05.11.20

VisionCare Announces CE Mark Approval of the Tsert-SI Delivery System for the CentraSight Treatment Program

Source: VisionCare

VisionCare has received CE Mark for the Tsert-SI delivery system for the CentraSight treatment program, which includes the Implantable Miniature Telescope (by Dr. Isaac Lipshitz). The Tsert-SI delivery system includes a pre-loaded telescope implant injector, which only requires a 6.5mm incision, reducing the incision size by nearly half.

“The Tsert-SI delivery system will allow surgeons to more quickly and more easily insert the telescope implant, which is demonstrated to restore vision and improve quality of life in people living with severe, blinding forms of macular degeneration,” Sumit Garg, MD, Associate Professor of Ophthalmology, Medical Director, and Vice Chair of Clinical Ophthalmology at the Gavin Herbert Eye Institute (University of California, Irvine), said in a company news release. “With a smaller incision size, the surgery will be more straightforward, and patients will have a faster visual recovery.”

The Tsert-SI delivery system includes a telescope implant with foldable haptics, which allows it to fit in the injector and be delivered through a smaller incision. During development, providers found that out-patient surgery procedural time using the injector system, which includes removal of a patient’s cataract and implantation of the implantable miniature telescope in one eye only, expected to drop from approximately 60 minutes to approximately 25 minutes (in routine procedures).

”We are excited that our years long effort to develop the Tsert-SI delivery system will allow ophthalmologists in the European Economic Area to offer the telescope implant and CentraSight treatment program to their patients with the goal of an enhanced patient experience,” Wolfgang Tolle, CEO of VisionCare, said in the news release. “We look forward to coordinating a meeting with the U.S. Food and Drug Administration to determine the timeline and pathway to bring this technology to United States health care providers.”

In the United States, the telescope implant is part of the CentraSight treatment program, which is for people 65 years and older diagnosed with end-stage, age-related macular degeneration who meet specific eye health and vision requirements, and for whom common treatments such as glasses, vitamins, drugs or cataract surgery will not lead to vision improvement. The telescope implant is contraindicated in patients with previous intraocular or corneal surgery of any kind in the operative eye, including cataract surgery.

 

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