Accelerating the New
Glaucoma Paradigm
Accelerating the New
Glaucoma Paradigm
Unlock first-line glaucoma care with Voyager™ DSLT
Consistent, precise treatment at the touch of a button.1
Hydrus® Microstent
The first and only MIGS device to report significant safety and effectiveness outcomes from a pivotal trial at 5 years.2,3
Important product information
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Intended Use: Voyager™ DSLT is a prescription device intended for use in performing selective laser trabeculoplasty.
Indications: Voyager™ DSLT is indicated for use in selective laser trabeculoplasty (SLT).
Contraindications: Use of the Voyager™ DSLT device is contraindicated in the following patients:
• Patients who are unable to fixate their head and/or eyes, such as patients suffering from uncontrolled nystagmus, tremors or similar conditions.
• Patients with a pupil that cannot constrict to a diameter of 4 mm or less.
Warnings:
• Users should wear laser safety eyewear while performing a procedure with the Voyager DSLT device to avoid injury to the user’s eyes.
• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure.
• Caution should be used when treating patients who have active uveitis or neovascularization that involves the iridocorneal angle with the Voyager DSLT device.
• The effect of selective laser trabeculoplasty energy on glaucoma implants located in the iridocorneal angle has not been studied. Because your version of the Voyager DSLT device does not allow masking of the implant area (i.e. ability to program a laser pattern which skips the local area of the implant), the use of the device is not recommended in eyes which have a glaucoma implant at any clock hour in the iridocorneal angle.
• In the pivotal clinical study of the Voyager DSLT device, the safety and effectiveness of re-treatment was not studied; therefore, the level of IOP reduction and potential for complications associated with re-treatment has not been established. Re-treatment is not recommended.
ATTENTION: Refer to the Voyager™ DSLT Directions for Use operating instructions and for the accessories/consumables and User Guide for a complete listing of indications, warnings, cautions and notes.
IMPORTANT PRODUCT INFORMATION CAUTION: Federal law restricts this device to sale by or on the order of a physician. INDICATIONS FOR USE: The Hydrus Microstent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).
CONTRAINDICATIONS: The Hydrus Microstent is contraindicated under the following circumstances or conditions: (1) In eyes with angle closure glaucoma; and (2) In eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber (AC) angle.
WARNINGS: Clear media for adequate visualization is required. Conditions such as corneal haze, corneal opacity or other conditions may inhibit gonioscopic view of the intended implant location. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, peripheral anterior synechiae (PAS), angle closure, rubeosis and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The surgeon should periodically monitor the status of the microstent with gonioscopy to assess for the development of PAS, obstruction of the inlet, migration, or device-iris or device-cornea touch. The Hydrus Microstent 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 or with risk factors for corneal compromise following cataract surgery. Prior to implantation, patients with history of allergic reactions to nitinol, nickel or titanium should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials.
PRECAUTIONS: If excessive resistance is encountered during the insertion of the microstent at any time during the procedure, discontinue use of the device. The safety and effectiveness of use of more than a single Hydrus Microstent has not been established. The safety and effectiveness of the Hydrus Microstent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, eyes with significant prior trauma, eyes with abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, eyes with preexisting pseudophakia, eyes with pseudoexfoliative or pigmentary glaucoma, and when implantation is without concomitant cataract surgery with IOL implantation. Please see a complete list of Precautions in the Instructions for use.
ADVERSE EVENTS: The most frequently reported finding in the randomized pivotal trial was peripheral anterior synechiae (PAS), with the cumulative rate at 5 years (14.6% vs 3.7% for cataract surgery alone). Other Hydrus postoperative adverse events reported at 5 years included partial or complete device obstruction (8.4%) and device malposition (1.4%). Additionally, there were no new reports of persistent anterior uveitis (2/369, 0.5% at 2 years) from 2 to 5 years postoperative. There were no reports of explanted Hydrus implants over the 5-year follow-up. For additional adverse event information, please refer to the Instructions for Use.
MRI INFORMATION: The Hydrus Microstent is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified conditions. Please see the Instructions for Use for complete
References:
1. Voyager DSLT User Guide (US). [REF-26202].
2. Ahmed IIK, et al. Long-term outcomes from the HORIZON randomized trial for Schlemm’s Canal microstent in combination cataract and glaucoma surgery. Ophthalmology. 2022;129(7):742-751.
Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients. ClinTrials.gov (NCT01539239).