The company is working with FDA on an IDE study, making its case with international data showing up to a 61% reduction in IOP at 6 months and 60% at 12 months. The blebless device requires ab externo surgery. An ab interno injectable MINIJect is under development.
“Because our silicone material is anti-fibrotic and anti-inflammatory, we strongly urge surgeons not to use mitomycin C or other antifibrotic agents during implantation,” said CEO Michel Vanbrabant. “The device itself takes care of those problems.”
Transcend Medical has taken the CyPass Micro-Stent through eight generations in more than 1,000 patients. The stent drains directly into the suprachoroidal space, which offers a large absorptive capacity and a natural pressure gradient to drive outflow. Non- FDA studies show a 35% reduction in IOP at 24 months when used with phacoemulsification and slightly less when used alone.
The pivotal COMPASS trial is fully enrolled with 505 patients, said Sean Ianchulev, MD, chief medical officer with initial data due later this year.
The next generation is the CyFlo Vx Infusion System, an injectable system that creates a reservoir to increase absorptive capacity. One-year results show 10 mm Hg drop in IOP compared to a 7 mm Hg drop using CyPass alone.
“Stent technology is a familiar modality in cardiovascular, pulmonary, gastrointestinal and other specialties,” Dr. Ianchulev said. “In ophthalmology, stent technology is the next frontier.”