APAC Important Safety Information
Australia
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent infinite Trabecular Micro-Bypass System Model iS3 is intended to reduce intraocular pressure in adult patients diagnosed with primary open-angle glaucoma (POAG) currently treated with ocular hypotensive medication. The device can be implanted with or without cataract surgery. CONTRAINDICATIONS. The iStent infinite System is contraindicated under the following circumstances or conditions: In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations; In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
New Zealand
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent infinite Trabecular Micro-Bypass System Model iS3 is intended to reduce intraocular pressure in adult patients diagnosed with primary open-angle glaucoma (POAG) currently treated with ocular hypotensive medication. The device can be implanted with or without cataract surgery. CONTRAINDICATIONS. The iStent infinite System is contraindicated under the following circumstances or conditions: In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations; In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
Hong Kong
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent infinite System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and/or conventional glaucoma surgery.
CONTRAINDICATIONS. The iStent infinite System is contraindicated under the following circumstances or conditions: In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations; In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite System is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: For prescription use only. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
Malaysia
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent infinite System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and/or conventional glaucoma surgery.
CONTRAINDICATIONS. The iStent infinite System is contraindicated under the following circumstances or conditions: In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations; In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite System is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: For prescription use only. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
Philippines
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent infinite System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and/or conventional glaucoma surgery.
CONTRAINDICATIONS. The iStent infinite System is contraindicated under the following circumstances or conditions: In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations; In patients with retrobulbar tumor, thyroid eye disease, Sturge- Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite System is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: For prescription use only. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
Singapore
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent infinite System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and/or conventional glaucoma surgery.
CONTRAINDICATIONS. The iStent infinite System is contraindicated under the following circumstances or conditions: In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations; In patients with retrobulbar tumor, thyroid eye disease, Sturge- Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite System is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: For prescription use only. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
South Korea
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent infinite System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and/or conventional glaucoma surgery.
CONTRAINDICATIONS. The iStent infinite System is contraindicated under the following circumstances or conditions: In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations; In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite System is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: For prescription use only. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
Taiwan
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent infinite System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and/or conventional glaucoma surgery.
CONTRAINDICATIONS. The iStent infinite System is contraindicated under the following circumstances or conditions: In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations; In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite System is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: For prescription use only. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
Thailand
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent infinite® Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed. CONTRAINDICATIONS. The iStent infinite is contraindicated in eyes with angle-closure glaucoma where the angle has not been surgically opened, acute traumatic, malignant, active uveitic, or active neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite is MRConditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
Australia
IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE: Trabecular Micro-Bypass System (Model G2-W) is intended to reduce intraocular pressure in adult patients diagnosed with mild to moderate primary open-angle glaucoma (POAG) currently treated with ocular hypotensive medication. The device can be implanted with or without cataract surgery. CONTRAINDICATIONS. The device is contraindicated for use in eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations, and in patients with retrobulbar tumour, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. This device has not been studied in patients with uveitic glaucoma. Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. iStent inject® is MR-Conditional, meaning that the device is safe for use in a specified MRI environment under specified conditions; please see labelling for details. Physician training is required prior to use and consists of 3 parts: webinar, Didactic session with Glaukos surgical representative and observation of surgical cases by Glaukos representative until implantation proficiency is demonstrated. Do not re-use the stent(s) or injector. ADVERSE EVENTS. Postoperative adverse events include but are not limited to: corneal complications including edema, opacification and decompensation, cataract formation (in phakic patients), posterior capsule opacification, stent obstruction, intraocular inflammation (non-preexisting), BCVA loss and IOP increase requiring management with oral or intravenous medications or surgical intervention. Please refer to Directions for Use for additional adverse event information. CAUTION: Please reference the Directions for Use labelling for a complete list of contraindications, warnings and adverse events.
New Zealand
IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE: Trabecular Micro-Bypass System (Model G2-W) is intended to reduce intraocular pressure in adult patients diagnosed with mild to moderate primary open-angle glaucoma (POAG) currently treated with ocular hypotensive medication. The device can be implanted with or without cataract surgery. CONTRAINDICATIONS. The device is contraindicated for use in eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations, and in patients with retrobulbar tumour, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. This device has not been studied in patients with uveitic glaucoma. Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. iStent inject® is MR-Conditional, meaning that the device is safe for use in a specified MRI environment under specified conditions; please see labelling for details. Physician training is required prior to use and consists of 3 parts: webinar, Didactic session with Glaukos surgical representative and observation of surgical cases by Glaukos representative until implantation proficiency is demonstrated. Do not re-use the stent(s) or injector. ADVERSE EVENTS. Postoperative adverse events include but are not limited to: corneal complications including edema, opacification and decompensation, cataract formation (in phakic patients), posterior capsule opacification, stent obstruction, intraocular inflammation (non-preexisting), BCVA loss and IOP increase requiring management with oral or intravenous medications or surgical intervention. Please refer to Directions for Use for additional adverse event information. CAUTION: Please reference the Directions for Use labelling for a complete list of contraindications, warnings and adverse events.
China
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE / SCOPE OF APPLICATION
The iStent inject W, Model G2-W glaucoma drainage device is intended for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in patients who have poor effectiveness using medication only or cannot receive medication with full open angle in static gonioscopy; who receive gonioscopic laser therapy at the same time but cannot have the disease progression controlled, or are not suited for receiving or cannot receive gonioscopic laser therapy as determined by a physician; and who cannot tolerate conventional filtering surgery for primary open-angle glaucoma in early and intermediate stage.
CONTRAINDICATIONS
The iStent inject W System is contraindicated under the following circumstances or conditions:
- In eyes with primary angle closure glaucoma;
- In eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber (AC) angle;
- In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
WARNINGS
- The following conditions may prohibit sufficient visualization of the angle required for safe and successful stent implantation: corneal haze, corneal opacity, or any other conditions that may inhibit the gonioscopic view in the intended implant location.
- The surgeon should perform a slit lamp gonioscopy examination prior to taking a patient to surgery to exclude congenital anomalies of the angle, including peripheral anterior synechiae (PAS), rubeosis, and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard.
- Patients with peripheral iridotomies are at risk of stent dislocation to the posterior chamber and related sequelae.
- The G2-W is intended for implantation in conjunction with cataract surgery, which may impact corneal health. Therefore, caution is indicated in eyes with evidence of corneal compromise (e.g., corneal guttae or low endothelial cell density) or with risk factors for corneal compromise following cataract surgery (e.g., advanced age, severe nuclear sclerosis).
- Non-clinical testing has demonstrated that the G2-W is MR Conditional. Please see the “MRI SAFETY INFORMATION” section at the end of this document on conditions for safe scanning.
PRECAUTIONS
- The surgeon should inform the patient that the stent is MR Conditional (as noted on their Patient ID card), and if the patient needs to undergo an MRI, they should let their doctor know they have an G2-W stent implanted in their eye.
- After the surgery, the surgeon should give the patient the Patient ID card (enclosed in the G2-W packaging) with the appropriate information filled in, and should advise the patient to keep the card in a safe place, e.g., his or her wallet, for future reference. The surgeon should advise the patient that this Patient ID card contains important information related to the G2-W and that the card should be shown to their current and future health care providers.
- The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate additional therapy to reduce intraocular pressure.
- The safety and effectiveness of the G2-W system has not been established as an alternative to the primary treatment of glaucoma with medications. The effectiveness of this device has been demonstrated only in patients with mild to moderate open-angle glaucoma who are undergoing concurrent cataract surgery for visually significant cataract.
- The safety and effectiveness of the G2-W product has not been determined in patients with the following circumstances or conditions which were not studied in the key clinical trial(s):
-
- In children;
- In eyes with obvious trauma;
- In eyes with abnormal anterior segment;
- In eyes with chronic inflammation;
- In glaucoma associated with vascular disorders;
- In patients with secondary pseudophakic glaucoma;
- In uveitic glaucoma;
- In eyes with prior incisional glaucoma surgery or cilioablative procedures;
- In eyes with prior laser trabeculoplasty (LT) with selective LT within 90 days prior to screening or prior argon laser trabeculoplasty (ALT) at any time;
- In patients with medicated intraocular pressure greater than 24 mmHg;
- In patients with unmedicated intraocular pressure less than 21 mmHg or greater than 36 mmHg;
- For implantation of more or less than two implants;
- For complications during cataract surgery, including, but not limited to, severe corneal burn, vitreous removal/vitrectomy required, corneal injuries, or complications requiring the replacement of an anterior chamber IOL;
- For implantation not in conjunction with cataract surgery with intraocular lens implantation to treat significant visual impairment;
- In patients with pseudoexfoliative glaucoma or pigmentary glaucoma, or in patients with other secondary open-angle glaucoma.
- The implant is comprised of implant grade titanium alloy (Ti6Al4V ELI) covered with a heparin coating. The total amount of heparin is estimated to be less than 0.9 μg per implant, or approximately 0.01 to 0.02 IU.
- In the process of stent implantation, surgeons should use caution to avoid contact with the cornea and the iris, in order to minimize sequela associated with contact between the device and the cornea, stent blockage, and /or iritis.
ADVERSE EVENTS
Refer to the Pivotal Clinical Trial Results section for the adverse events that occurred in the pivotal clinical trial. Additional adverse events that may be reasonably associated with the use of the device include but are not limited to the following: anterior chamber shallowing, severe, prolonged, or persistent intraocular inflammation, intraocular inflammation, aqueous misdirection, choroidal effusion, choroidal hemorrhage, corneal decompensation, corneal injury, corneal opacification, cyclodialysis cleft, damage to trabecular meshwork, hyphema, hypopyon, hypotony, hypotony maculopathy, IOL dislocation, iridodialysis, loss of vitreous, perforation of sclera, posterior capsular bag rupture, proliferative vitreoretinopathy, pupillary block, pupillary membrane formation, retinal detachment, retinal dialysis,retinal flap tears, secondary surgical intervention, including but not limited to glaucoma surgery, premature stent release, stent dislocation, stent not retrievable, stent not visible with gonioscopy, over implanted stents that are not visible with gonioscopy, stent malfunction, and vitreous hemorrhage (TASS).
CAUTION
Please reference the Directions For Use labelling for a complete list of contraindications, warnings and adverse events.
Malaysia
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE: The iStent inject W, is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The iStent inject W, can deliver two (2) stents on a single pass, through a single incision. The implant is designed to stent open a passage through the trabecular meshwork to allow for an increase in the facility of outflow and a subsequent reduction in intraocular pressure.
The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery.
CONTRAINDICATIONS
The iStent inject W System is contraindicated under the following circumstances or conditions:
- In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations
- In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
WARNINGS/PRECAUTIONS
- For prescription use only.
- This device has not been studied in patients with uveitic glaucoma.
- Do not use the device if the Tyvek® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised.
- Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container.
- iStent inject W is MR-Conditional; see MRI Information below.
- Physician training is required prior to use of the iStent inject W System, and consists of three main parts:
- Webinar
- Didactic session with Glaukos surgical representative
- Observation of surgical cases by Glaukos representative until implantation proficiency is demonstrated
- Do not re-use the stent(s) or injector, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events as shown below under “Potential Complications.”
- There are no known compatibility issues with the iStent inject W and other intraoperative devices
- (e.g., viscoelastics) or glaucoma medications.
- Unused product & packaging may be disposed of in accordance with facility procedures. Implanted medical devices and contaminated products must be disposed of as medical waste.
- The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate treatment regimen to reduce intraocular pressure.
- Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract.
ADVERSE EVENTS
Please refer to Directions For Use for additional adverse event information.
CAUTION
Please reference the Directions For Use labelling for a complete list of contraindications, warnings and adverse events.
Philippines
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE:
The iStent inject W, is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The iStent inject W, can deliver two (2) stents on a single pass, through a single incision. The implant is designed to stent open a passage through the trabecular meshwork to allow for an increase in the facility of outflow and a subsequent reduction in intraocular pressure.
The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery.
CONTRAINDICATIONS
The iStent inject W System is contraindicated under the following circumstances or conditions:
- In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations
- In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
WARNINGS/PRECAUTIONS
- For prescription use only.
- This device has not been studied in patients with uveitic glaucoma. • Do not use the device if the Tyvek® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised.
- Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container.
- iStent inject W is MR-Conditional; see MRI Information below.
- Physician training is required prior to use of the iStent inject W System, and consists of three main parts:
- Webinar
- Didactic session with Glaukos surgical representative
- Observation of surgical cases by Glaukos representative until implantation proficiency is demonstrated
- Do not re-use the stent(s) or injector, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events as shown below under “Potential Complications.”
- There are no known compatibility issues with the iStent inject W and other intraoperative devices
- (e.g., viscoelastics) or glaucoma medications.
- Unused product & packaging may be disposed of in accordance with facility procedures. Implanted medical devices and contaminated products
- must be disposed of as medical waste.
- The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate treatment regimen to reduce intraocular pressure.
- Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract.
ADVERSE EVENTS
Please refer to Directions For Use for additional adverse event information.
CAUTION
Please reference the Directions For Use labelling for a complete list of contraindications, warnings and adverse events.
Thailand
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE:
The iStent inject W, is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The iStent inject W, can deliver two (2) stents on a single pass, through a single incision. The implant is designed to stent open a passage through the trabecular meshwork to allow for an increase in the facility of outflow and a subsequent reduction in intraocular pressure.
The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery.
CONTRAINDICATIONS
The iStent inject W System is contraindicated under the following circumstances or conditions:
- In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations
- In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
WARNINGS/PRECAUTIONS
- For prescription use only.
- This device has not been studied in patients with uveitic glaucoma.
- Do not use the device if the Tyvek® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised.
- Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container.
- iStent inject W is MR-Conditional; see MRI Information below.
- Physician training is required prior to use of the iStent inject W System, and consists of three main parts:
- Webinar
- Didactic session with Glaukos surgical representative
- Observation of surgical cases by Glaukos representative until implantation proficiency is demonstrated
- Do not re-use the stent(s) or injector, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events as shown below under “Potential Complications.”
- There are no known compatibility issues with the iStent inject W and other intraoperative devices
- (e.g., viscoelastics) or glaucoma medications.
- Unused product & packaging may be disposed of in accordance with facility procedures. Implanted medical devices and contaminated products must
- be disposed of as medical waste.
- The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate treatment regimen to reduce intraocular pressure.
- Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract.
ADVERSE EVENTS
Please refer to Directions For Use for additional adverse event information.
CAUTION
Please reference the Directions For Use labelling for a complete list of contraindications, warnings and adverse events.
Vietnam
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE:
The iStent inject W, is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The iStent inject W, can deliver two (2) stents on a single pass, through a single incision. The implant is designed to stent open a passage through the trabecular meshwork to allow for an increase in the facility of outflow and a subsequent reduction in intraocular pressure. The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery.
CONTRAINDICATIONS
The iStent inject W System is contraindicated under the following circumstances or conditions: • In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations • In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
WARNINGS/PRECAUTIONS
- For prescription use only.
- This device has not been studied in patients with uveitic glaucoma.
- Do not use the device if the Tyvek® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised.
- Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container.
- iStent inject W is MR-Conditional; see MRI Information below.
- Physician training is required prior to use of the iStent inject W System, and consists of three main parts:
- Webinar
- Didactic session with Glaukos surgical representative
- Observation of surgical cases by Glaukos representative until implantation proficiency is demonstrated
- Do not re-use the stent(s) or injector, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events as shown below under “Potential Complications.”
- There are no known compatibility issues with the iStent inject W and other intraoperative devices
- (e.g., viscoelastics) or glaucoma medications.
- Unused product & packaging may be disposed of in accordance with facility procedures. Implanted medical devices and contaminated products must
- be disposed of as medical waste.
- The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate treatment regimen to reduce intraocular pressure.
- Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract.
ADVERSE EVENTS
Please refer to Directions For Use for additional adverse event information.
CAUTION
Please reference the Directions For Use labelling for a complete list of contraindications, warnings and adverse events.
IMPORTANT SAFETY INFORMATION
INDICATION FOR USE. The MicroShunt is intended for reduction of intraocular pressure in eyes of patients with primary open angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. CONTRAINDICATIONS. The implantation of the MicroShunt is contraindicated under the following circumstances and conditions: ANGLE CLOSURE GLAUCOMA; PRESENCE OF CONJUNCTIVAL SCARRING, PREVIOUS INCISIONAL OPHTHALMIC SURGERY INVOLVING THE CONJUNCTIVA OR OTHER CONJUNCTIVAL PATHOLOGIES (E.G., THIN CONJUNCTIVA, PTERYGIUM) IN THE TARGET QUADRANT; ACTIVE IRIS NEOVASCULARIZATION; ACTIVE INFLAMMATION (E.G., BLEPHARITIS, CONJUNCTIVITIS, SCLERITIS, KERATITIS, UVEITIS); SECONDARY GLAUCOMA SUCH AS POSTTRAUMATIC, PSEUDOEXFOLIATION OR PIGMENTARY; VITREOUS IN THE ANTERIOR CHAMBER; PRESENCE OF AN ANTERIOR CHAMBER INTRAOCULAR LENS (ACIOL); INTRAOCULAR SILICONE OIL. WARNINGS. Rx only: This device is restricted to sale by, or on the order of, a physician. For one-time use only. Do not reuse or re-sterilise. Reuse, or re-sterilisation may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in serious patient injury, illness, blindness or death. Reuse, or re-sterilisation may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, blindness, or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative, and/or local government policy. Long term effects of Mitomycin C (MMC) with the use of this device have not been evaluated. Necessary precautions and interventions on the use of MMC are highly recommended. The patient’s IOP should be monitored postoperatively. If IOP is not adequately maintained after surgery, appropriate additional therapy to maintain IOP should be considered. The MicroShunt should not be subjected to direct contact with petrolatum-based (i.e., petroleum jelly) materials (e.g., ointments, dispersions, etc.). No cutting or modification of the MicroShunt is allowed. POTENTIAL COMPLICATIONS / ADVERSE EVENTS. The complications during and after surgery may include: Glaucoma progression not controlled, increase in cup-to-disc ratio (C/D), anaesthesia related complications, difficulty in inserting the MicroShunt, failure to implant the device, device malfunction, device repositioning, extended surgical procedure, tube migration out of anterior chamber, flat anterior chamber, shallow anterior chamber, excessive bleeding in anterior chamber or incision site or eye, MicroShunt touches cornea or iris, intraocular pressure too high or low, strabismus, viscoelastic used in anterior chamber, choroidal effusion or hemorrhage, retinal complications (retinal detachment, proliferative retinopathy), hyphema, hypotony or hypotony maculopathy, phthisis bulbi, endophthalmitis, tube erosion through conjunctiva, tube obstruction partial or complete (block by iris or vitreous or fibrin or debris), uveitis, iritis, diplopia, aqueous misdirection, corneal complications (abrasion, edema, ulceration, infection, decompensation, bullous keratopathy, endothelial cell loss, Descemet striae, keratitis), partial or complete vision loss, blurry vision, bleb leak, blebitis, cystic bleb, bleb failure, pupillary block, ptosis, macular edema, prolonged inflammation, use of glaucoma medications, ocular pain, conjunctival complications (buttonhole, dehiscence, dissection, hemorrhage, hyperemia, scar, tear, ulcer), iris adhesions/synechiae, iris abrasion, cataract development or progression, posterior capsule opacity, explantation of the MicroShunt, encapsulation reaction, foreign body sensation, fibrin in anterior chamber, visual field damage, unplanned glaucoma-related surgical re-intervention, optic disc hemorrhage, globe perforation, headache, vitreous hemorrhage, wound leak, and suture related complications.
The KXL® System delivers a uniform, metered dose of UVA light to a targeted treatment area for the intended use of illuminating the cornea during corneal cross-linking procedures stabilising cornea which have been weakened by disease or by refractive surgery.
VibeX & Mediocross riboflavin are indicated for use in the treatment of corneal strengthening, progressive keratoconus, iatrogenic ectasia, pellucid marginal degeneration.
VibeX & Mediocross riboflavin formulation is CE Marked and can be accessed through the TGA Special Access Scheme (SAS) in Australia.
iStent® (G1) Important Safety Information
INDICATIONS FOR USE
The iStent® Trabecular Micro-Bypass System is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery.
CONTRAINDICATIONS
The iStent® Trabecular Micro-Bypass Stent is contraindicated under the following circumstances or conditions: In eyes with primary angle-closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations. In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
WARNINGS/PRECAUTIONS:
This device has not been studied in patients with uveitic glaucoma. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. iStent is MR-Conditional meaning that the device is safe for use in a specified MRI environment under specified conditions, please see labeling for details. Physician training is required prior to use. Do not re-use the stent(s) or inserter.
ADVERSE EVENTS
The most common post-operative adverse events reported in the randomized pivotal trial included early post-operative corneal edema (8%), BCVA loss of ≥ 1 line at or after the 3 month visit (7%), posterior capsular opacification (6%), stent obstruction (4%) early post-operative anterior chamber cells (3%), and early post-operative corneal abrasion (3%). Please refer to Directions for Use for additional adverse event information.
CAUTION
Please reference the Directions for Use labeling for a complete list of contraindications, warnings, precautions, and adverse events.