Isnes, Belgium (Oct 30, 2014) – iSTAR Medical SA, a privately held ophthalmic device company, announced today that the first patient in its European multi-center clinical trial has been successfully implanted with the STARflo™ glaucoma drainage device.
The study will be conducted at leading clinical study sites across Europe to evaluate the effectiveness and safety of the STARflo™ system in patients with Open-angle glaucoma and is designed to support broader adoption of STARflo™ in geographies where it has been approved. STARflo received European CE Mark approval in 2012 and is currently available through distributors in select countries.
The first implantation procedure in the clinical trial was successfully performed by Professor Christophe Baudouin, head of the Ophthalmology Department at the Quinze-Vingt National Ophthalmologic University Hospital in Paris, France.
“The STARflo device provides a unique drainage mechanism for patients presenting with advanced or refractory glaucoma and fills an unmet clinical need for patients at high risk of failure following traditional filtering surgery,” said Professor Baudouin. “The bleb-free implantation procedure and soft material of STARflo are designed to offer a sustainable reduction of intra ocular pressure.”
“STARfloTM brings an unprecedented mode of action that sets it apart from any other treatment option available to glaucoma patients today,” said Michel Vanbrabant, CEO of iStar. “STARflo’s unique material mimics healthy eye tissue, enhances physiological draining pathways and has been designed to minimize scarring without requiring use of anti-metabolites. We are excited to partner with leading glaucoma experts around Europe to increase the level of scientific evidence supporting STARflo as a superior treatment option for improving long-term efficacy and reducing post-operative care for glaucoma patients.”
About Glaucoma and STARflo™
Glaucoma is the leading cause of irreversible blindness worldwide. By 2020, it is estimated that 80 million people worldwide will have the disease. Elevated intraocular pressure is considered a major risk factor for glaucoma and its progression. STARflo is a non-degradable, precision-pore, implant made from STAR® Biomaterial. It is designed to operate as a bleb-free, micro-porous drainage system to reduce intraocular pressure (IOP) in patients suffering from open-angle glaucoma by augmenting the eye’s natural uveoscleral outflow.