CHICAGO, IL--(Marketwire - April 21, 2012) -
Transcend Medical, Inc., an ophthalmic device company dedicated to developing minimally invasive glaucoma therapies, announced that the CyPass Micro-Stent® will be the subject of four clinical presentations this week at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting.
"These ASCRS abstracts, and in particular the preliminary twelve-month CyCLE data from our international colleagues, demonstrate the potential for the CyPass Micro-Stent to safely reduce and stabilize intraocular pressure over time with minimal side effects," commented Steve Vold, MD, Steering Committee Chairman for the COMPASS clinical trial, which is evaluating the CyPass® device in the United States.
The four scientific abstracts accepted for publication include:
- Intraocular Pressure-Lowering Effect of Suprachoroidal Micro-Stent in Combination with Phaco Cataract Surgery; presented by E. Randy Craven, MD, which will include new 12-month international efficacy and safety data
- Surgical Outcomes and Safety of Novel Supraciliary Micro-Stent; presented by S. D. Vold, MD
- Use of Anterior Segment OCT for Deep-Angle Visualization After Micro-Stent Implantation; presented by Ike K. Ahmed, MD
- Gonio-Free Minimally Invasive Glaucoma Suprachoroidal Micro-Stent; presented by T. Ianchulev, MD
The CyPass Micro-Stent is the first micro-invasive glaucoma stent designed to drain aqueous fluid toward the suprachoroidal space. It is designed to reduce intraocular pressure (IOP) by bypassing the trabecular meshwork and Schlemm's canal -- drainage paths that may be diseased in glaucomatous eyes -- and by enhancing uveoscleral outflow, one of the eye's alternative, natural drainage pathways. This device is currently being studied in combination with cataract surgery in the COMPASS multicenter clinical trial, one of the largest randomized, controlled, studies in surgical glaucoma to date.
"We are encouraged by both the clinical data and our overall progress with the CyPass Micro-Stent technology," said Brian Walsh, President and Chief Executive Officer of Transcend Medical. "In the U.S., the COMPASS pivotal trial, which has already achieved 50 percent enrollment, has set a new standard for surgical device trials in the mild-to-moderate glaucoma population in that it is designed to evaluate product risks and benefits through two years of follow-up while eliminating the confounding factor of glaucoma medication use."
Ike K. Ahmed, MD, FRCSC, Assistant Professor at the University of Toronto, stated, "To date, the CyPass Micro-Stent is the most studied minimally invasive device that takes advantage of the high potential, pressure-lowering physiology of the suprachoroidal drainage path. Implanting the CyPass device is a very straightforward procedure, resulting in IOP-lowering and quick recovery."
About the CyPass Micro-Stent®
The CyPass Micro-Stent is the first micro-invasive glaucoma stent designed to drain aqueous fluid toward the suprachoroidal space. It is about the size of a grain of rice and is made of polyimide, a highly biocompatible polymer. Once in place, the CyPass Micro-Stent is designed to provide 24-hour IOP control, which may reduce the risk of glaucoma disease progression. While CE mark for the device was granted in 2008, the CyPass Micro-Stent is for investigational use only.
About the COMPASS Clinical Study
The COMPASS clinical study, which is under way at over 20 study sites in the U.S., is a large randomized, controlled trial evaluating the CyPass Micro-Stent in combination with cataract surgery against cataract surgery alone for the treatment of glaucoma. For more information about the study, please visit www.compassclinicalstudy.com.
About Transcend Medical, Inc.
Transcend Medical (www.transcendmedical.com) is focused on the development of minimally invasive medical devices for the treatment of glaucoma, the leading cause of adult irreversible blindness. Over 4 million people in the U.S. and roughly 60 million worldwide are afflicted with the disease today and the numbers are expected to grow to nearly 6 million in the U.S. and over 70 million worldwide by the year 2015.