| | IRVINE, Calif., Dec. 16, 2020 /PRNewswire/ --Ivantis, Inc., developer of the novel Hydrus® Microstent, a minimally invasive glaucoma surgery (MIGS) device designed to lower eye pressure in patients with open-angle glaucoma, is proud to be the recipient of multiple awards and recognition this year for its innovation and excellence in helping to change the standard of care for the world’s 80 million glaucoma patients, as well as its positive, supportive company culture. “It’s truly an honor to be recognized for our commitment to innovation and excellence in the fight against glaucoma.” The company has received several “best places to work” designations. Ivantis was ranked No. 4 on The Orange County Register’s Top Workplaces 2020 list and was also the only medical device company, at No. 15, on the Orange County Business Journal’s 2020 Best Places to Work list. Additional awards and recognition include: “It’s truly an honor to be recognized for our commitment to innovation and excellence in the fight against glaucoma, as well as our empowering, fun and supportive corporate culture,” said Dave Van Meter, president and CEO of Ivantis. “To receive so many awards and recognition during what has been an unprecedented and challenging year for so many in our community is humbling. We share this acknowledgment with our entire team and thank them for their hard work, resolve and dedication to our mission. Everyone at Ivantis is passionate about making a difference in the lives of glaucoma patients worldwide and delivering innovative, high-quality products for clinicians, and we look forward to continuing to innovate together.” To learn more, visit Ivantisinc.com. About Hydrus Microstent
Roughly the size of an eyelash, the Hydrus Microstent is a next-generation MIGS device designed to reduce eye pressure by reestablishing flow through Schlemm’s canal, the eye’s natural outflow pathway. When placed in the canal during minimally invasive microsurgery, the device restores the flow of fluid in the eye, using a Tri-Modal® mechanism of action: - The Hydrus Microstent dilates and scaffolds Schlemm’s canal to augment outflow of aqueous humor from the anterior chamber.
- It maintains an opening through the trabecular meshwork from the anterior chamber into Schlemm’s canal.
- Its length spans approximately 90 degrees of the canal to provide consistent access to multiple fluid collector channels in the eye.
Approved by the Food and Drug Administration in August 2018 for use in conjunction with cataract surgery, the Hydrus Microstent is one of the most rigorously researched and thoroughly studied MIGS devices, with more than 4,000 cases treated globally in controlled clinical studies and registries in patients with a wide range of disease severities. About Ivantis
Ivantis Inc. is a privately held company established in 2007 to design, develop and commercialize new technologies to treat eye disease. Investors include New Enterprise Associates, Delphi Ventures, Foresite Capital, RA Capital Management, Ascension Ventures, EDBI, GBS Ventures, MemorialCare Innovation Fund, Merieux Development and Vertex Healthcare. The company is headquartered in Irvine, California. Ivantis, Hydrus and Tri-Modal are registered trademarks of Ivantis Inc. All rights reserved 2020. References - Gedde SJ, Vinod K, Wright MM, Muir KW, Lind JT, Chen PP, Li T, Mansberger SL, on behalf of the American Academy of Ophthalmology Preferred Practice Pattern Glaucoma Panel, Primary Open-Angle Glaucoma Preferred Practice Pattern®. Ophthalmology. 2020. doi:10.1016/j.ophtha.2020.10.022
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. 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 > 34 mmHg, 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 the use of more than a single Hydrus Microstent has not been established. ADVERSE EVENTS
Common postoperative 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 ≥ three 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 MRI environment under specified conditions of use; please see the Instructions for Use and Patient Information Card for details. Please refer to the Instructions for Use for complete product information. www.IvantisInc.com Media Contact
Capwell Communications
info@capwellcomm.com
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SOURCE Ivantis, Inc. | |
