VisionCare, Inc has announced designation of the Conformité Européene (CE) mark for the Tsert-SI™ delivery system for the CentraSight treatment program. The CentraSight treatment program includes the Implantable Miniature Telescope for treatment of end-stage age-related macular degeneration (AMD) and is available in many countries, including the United States, Europe, Australia, New Zealand, and Israel.
Smaller than a pea, the Implantable Miniature Telescope (by Dr. Isaac Lipshitz) is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation. The telescope implant is part of the CentraSight treatment program, which has been designed to help patients follow the necessary steps for proper diagnosis, surgical evaluation, and postoperative care.
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. The pre-loaded telescope implant injector only requires a 6.5mm incision, reducing the incision size by nearly half. 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).
“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,” said 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). “With a smaller incision size, the surgery will be more straightforward, and patients will have a faster visual recovery.”
”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,” stated Wolfgang Tolle, CEO of VisionCare, Inc. “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.”
Full press release: https://www.businesswire.com/news/home/20200511005232/en/VisionCare-Announces-CE-Mark-Approval-Tsert-SI%E2%84%A2-Delivery