Hydrus Microstent – Micro-Invasive Glaucoma Surgery – Dr. Lewis
Serving Northeast Philadelphia, the Main Line, King of Prussia, Conshohocken, Philadelphia, Phoenixville, Willow Grove, Abington, and surrounding areas.
Hydrus® Microstent Fact Sheet
Facts about Hydrus:
– Roughly the size of an eyelash, the Hydrus® Microstent is a revolutionary new minimally invasive glaucoma surgery (MIGS) device designed to reduce eye pressure by reestablishing the patient’s natural outflow pathway (known as Schlemm’s canal) through which fluid (called aqueous humor) exits the eye .
– The Hydrus Microstent is placed in the eye by a surgeon using a small incision in a minimally invasive procedure. This less invasive approach may allow for fewer complications and faster healing times than traditional incisional glaucoma surgery.
– The unique design of the Hydrus Microstent provides a Tri-Modal mechanism of action to treat glaucoma:
- The device opens a bypass through the trabecular meshwork, a common site of aqueous blockage in the eye;
- It then dilates and scaffolds (keeps open) an important part of the eye called Schlemm’s canal to enhance flow; and
- The device spans a full 90 degrees within the canal. This coverage is designed to ensure that fluid reaches the eye’s drainage system, which carries fluid from Schlemm’s Canal in to the body’s circulatory system and allows pressure in the eye to be lowered
– The Hydrus Microstent is one of the most studied glaucoma devices to date, with more than 4,000 cases treated globally in patients with a wide range of disease severities.
– The FDA approval is based on the landmark HORIZON Trial, the largest MIGS clinical study ever conducted. The study included 556 adult patients with open-angle glaucoma and was conducted at 38 centers in nine countries. The study demonstrated the safety and effectiveness of the Hydrus Microstent with cataract surgery to lower intraocular pressure (IOP) compared to the control which was cataract surgery alone. 1
- In this pivotal study more than 78 percent of Hydrus Microstent patients remained medication-free compared to 48 percent in the control group, a 30 percent difference and the largest improvement versus control of any MIGS pivotal trial to date.
- Additionally Hydrus Microstent patients had a 43% lower intraocular pressure at 2 years compared to the control group
Facts about Glaucoma:
– Glaucoma is a leading cause of blindness and affects more than 70 million people worldwide; it is estimated that over 4 million patients have glaucoma in the United States.2 There is no cure for glaucoma, but its long term effects may be prevented with early detection, medication use and other treatments, including surgery.
– Glaucoma is a group of eye diseases that occur due to increased pressure in the eye caused by a buildup of excess fluid. Treatment is aimed at lowering pressure to prevent further loss of vision.
About Ivantis:
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Ivantis, Inc. is a privately held company established in 2007 to design, develop and commercialize new technologies to treat eye disease.
FAQs:
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Q: Who are candidates for this procedure?
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A: The Hydrus Microstent is indicated for use in conjunction with cataract surgery to treat adult patients who have mild to moderate primary open angle glaucoma. Your doctor can provide you with additional information to determine if you may be a candidate.
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Q: What can patients expect during and after the procedure?
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A: The Hydrus Microstent is an outpatient procedure designed to be quick and minimally
invasive for the patient. Typically performed using topical anesthesia, the Hydrus Microstent is implanted in conjunction with cataract surgery. Patients will be able to go home the same day, following the procedure. Patients will not be able to see or feel the tiny device in
the eye.
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Q: What are the alternative treatment options for glaucoma?
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A: Current therapies include prescription eye drops, laser therapy, and surgery. The advent of minimally invasive glaucoma devices, such as the Hydrus Microstent, offer a new solution
designed to safely and effectively reduce eye pressure and reliance on medical eye drops.
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Q: When does the procedure start to work for patients after surgery?
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A: Although patients will not be able to feel the Hydrus Microstent once its implanted, patients will know soon how well the device is working. In the weeks following the procedure, your doctor will test your IOP to determine if the pressure in your eye has been adequately lowered.
Hydrus® Microstent Important Safety 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, peripheralanterior synechiae (PAS), angle closure, rubeosis and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard.
PRECAUTIONS
The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. 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 uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open angle glaucomas, eyes that have undergone prior incisional glaucoma surgery or cilioablative procedures, eyes that have undergone argon laser trabeculoplasty (ALT), eyes with unmedicated IOP < 22 mmHg or > 34mmHg, eyes with medicated IOP > 31 mmHg, eyes requiring > 4 ocular hypotensive medications prior to surgery, in the setting of complicated cataract surgery with iatrogenic injury to the anterior or posterior segment and when implantation is without concomitant cataract surgery with IOL implantation. The safety and effectiveness of use of more than a single Hydrus Microstent has not been established.
ADVERSE EVENTS
Common post operative adverse events reported in the randomized pivotal trial included partial or complete device obstruction (7.3%); worsening in visual field MD by > 2.5 dB compared with preoperative (4.3% vs. 5.3% for cataract surgery alone); device malposition (1.4%); and BCVA loss of ≥ 2 ETDRS lines ≥ 3 months (1.4% vs. 1.6% for cataract surgery alone). 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 condition, please see the Instructions for Use and Patient Information Card for details.
Please refer to the Instructions for Use for complete product information.
1. A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract: The HORIZON Study. Ophthalmology. In press, corrected proof. Available online June 23, 2018. Thomas W. Samuelson, David F. Chang, Robert Marquis, Brian Flowers, et al; HORIZON Investigators.
2. 2017 Glaucoma Surgical Device Report: A global Market Analysis for 2016 to 2020, Market Scope, LLC.
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