Transcend Medical
The CyPass Micro-Stent has been implanted in more than 1,000 patients over the course of 10 years as part of multiple clinical trials, and Transcend expects to submit to the FDA during 3Q 2105. The device already has the CE Mark, and two post-marketing European studies are ongoing.
The CyPass creates a controlled outflow pathway to the suprachoroidal space. The device is about 6-mm long, and can be placed through a 1.5-mm corneal incision. The Micro-Stent has a 300-μm lumen and is placed into the iridocorneal angle with its distal portion resting in the supraciliary space.
The COMPASS study has randomized 505 patients across 27 sites in the U.S. The primary effectiveness endpoint for the study is the proportion of eyes with ≥20% decrease in intraocular pressure (IOP) from baseline to the medication-free 24-month postoperative examination. At 12 months, patients averaged a 9.9 mmHg decrease and remained medication-free.
Participant:
Sean Ianchulev, MD, MPH
Dr. Ianchulev is a physician-executive, innovator and venture capital investor with deep life-science and medical technology expertise.