First clinical trial patient receives STARflo

iSTAR Medical SA announced that the first patient in its European multicentre clinical trial has been successfully implanted with the company's STARflo glaucoma drainage device.

STARflo is a non-degradable implant made from iStar Medical's STAR biomaterial. It is designed to operate as a bleb-free, micro-porous drainage system to reduce intraocular pressure in patients with open-angle glaucoma by augmenting the eye's natural uveoscleral outflow.

The implantation marks the first in a study that will be conducted across Europe to evaluate the effectiveness and safety of the STARflo system in patients with open-angle glaucoma. STARflo received European CE Mark approval in 2012 and is currently available through distributors in select countries.

The implantation procedure was successfully performed 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 Christophe Baudouin, head of the Ophthalmology Department at the Quinze-Vingt National Ophthalmologic University Hospital. "The bleb-free implantation procedure and soft material of STARflo are designed to offer a sustainable reduction of intraocular pressure."

"STARflo's unique material mimics healthy eye tissue, enhances physiological draining pathways and has been designed to minimize scarring without requiring the use of anti-metabolites," added Michel Vanbrabant, CEO of iStar. "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."

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