Menlo Park, CA. (October 22, 2015) – Transcend Medical, Inc., a pioneer of minimally invasive glaucoma surgery (MIGS), today announced the submission to the U.S. Food and Drug Administration (FDA) of the final module of the company’s Premarket Approval (PMA) application for the CyPass® Micro-Stent.
The CyPass Micro-Stent is a MIGS implant designed to reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma. The final module includes two-year patient follow-up data from the COMPASS pivotal clinical trial, in which more than 500 patients in over 20 sites throughout the U.S. were enrolled, making it the largest completed, randomized, controlled trial in the field of MIGS. In the study, the CyPass Micro-Stent demonstrated superiority over the control by achieving both primary and secondary endpoints at one and two years.
“We are very pleased to have attained this important milestone and have the CyPass Micro-Stent be the next MIGS technology submitted to FDA for premarket approval,” said Brian Walsh, President and Chief Executive Officer of Transcend Medical. “With the robust results from the COMPASS study, we believe the CyPass can provide a compelling treatment option for mild-to-moderate glaucoma patients undergoing cataract surgery.”
About the CyPass® Micro-Stent
The CyPass Micro-Stent is the first minimally invasive glaucoma stent designed to reduce IOP by enhancing aqueous outflow to the suprachoroidal space. Implanted using a minimally invasive procedure, the CyPass Micro-Stent avoids the trabecular meshwork and Schlemm’s canal—a drainage pathway that is believed to be compromised in glaucomatous eyes. The CyPass Micro-Stent has received the CE Mark and was the subject of investigation for the treatment of mild-to-moderate glaucoma the U.S. in the COMPASS Clinical Study.
About the COMPASS study
The COMPASS study was a prospective, multicenter, randomized, controlled trial conducted at more than 20 sites throughout the U.S. under an Investigational Device Exemption (IDE) as part of the PMA requirements for the CyPass Micro-Stent. Over 500 adult patients with mild-to-moderate glaucoma undergoing cataract surgery were randomized to either receive the CyPass Micro-Stent after cataract surgery or undergo no further intervention.
About Transcend Medical, Inc.
Transcend Medical (www.transcendmedical.com) is a privately-held, venture-backed medical device company focused on the development of minimally invasive glaucoma interventions for the ophthalmic surgeon. Glaucoma is the leading cause of adult irreversible blindness, with nearly 6 million in the U.S. and over 70 million worldwide affected by the disease today. Glaucoma is a progressive disease of the optic nerve, usually the result of abnormally high intraocular pressure (IOP). While topical medications to lower IOP are considered first-line therapy and represent a nearly $5 billion market,1 patient adherence is low,2 and many require alternative therapies.
Transcend Medical Submits Final Module of FDA Premarket Approval Application for the CyPass® Glaucoma Micro-Stent Transcend Medical, Inc.
CyPass is a registered trademark, and Transcend is a trademark, of Transcend Medical, Inc. *Caution: Investigational Device. Limited by Federal (U.S.) law to investigational use.
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For more information, please contact:
Ravi Pamnani
Transcend Medical, Inc.
+1-650-223-6625
rpamnani@transcendmedical.com
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