Samsara Vision’s new generation SING IMT received a CE mark for the European Union in 2020. The SING IMT procedure features the Tsert SI pre-loaded delivery system, and only requires a 6.5mm incision, which reduces the incision size by nearly half. The 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, including removal of a patient’s cataract and implantation of the implantable miniature telescope in one eye only, was expected to drop from approximately 60 minutes to approximately 25 minutes (in routine procedures). The SING IMT is not currently FDA approved. Samsara Vision is working with the U.S. Food and Drug Administration to determine the timeline and pathway to bring this technology to United States health care providers. Presently, the SING IMT (not currently FDA approved) is indicated for monocular (one-eye) implantation to improve vision in eyes of patients at least 55 years of age with severe to profound vision impairment caused by bilateral central scotomas (scars) associated with end-stage age-related macular degeneration (AMD). Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular lens placement are contraindicated for telescope surgery.
IMT 3X implantable device packaged with the Tsert SI delivery system. The Implantable Miniature Telescope is referred to as "the IMT (by Dr. Isaac Lipshitz)" or as "the Implantable Miniature Telescope (by Dr. Isaac Lipshitz)."