Minimally invasive radiation treatment for wet AMD nears market
Howard Larkin
Published: Thursday, September 8, 2016
Inserted into the sub-Tenon’s space, the lighted tip of the Salutaris SMD-DA can be seen through an ophthalmoscope, allowing precise positioning of a radioisotope seed under wet AMD lesions
Salutaris Medical Devices introduced a new generation of its epsicleral brachytherapy device for treating necovascular age-related macular degeneration at the Ophthalmology Futures European Forum in Copenhagen, Denmark, Thursday. Designed to reduce the need for ongoing anti-VEGF intravitreal injections, the new device is expected to receive the CE Mark by year’s end, said Salutaris CEO Laurence J Marsteller MD.
“Our new commercial-ready applicator system is a significant marker of SalutarisMD’s continued progress and we are looking forward to positively affecting patient outcomes,” Dr Marsteller said.
The new SMD-DA device treats wet AMD by exposing a target lesion to a strontium-90 radioisotope seed delivering ionizing radiation with anti-angiogenic and anti-inflammatory effects. It consists of a curved cannula with a lighted tip, which is placed directly behind the target lesion. The seed is then advanced from the handle to precisely deliver a prescribed radiation dose. Because it does not penetrate the globe, the 15-minute outpatient procedure is safer than brachytherapy using an epimacular probe, which requires vitrectomy, Dr Marsteller noted.
SMD-DA improves dosimetry control over the first-generation SMD-1, increasing chances that the entire target lesion will be treated, Dr Marsteller said. In a test of the earlier device, three of four treatment-naïve patients and one of two chronically treated wet AMD patients saw best corrected visual acuity improve four to 25 letters two years following treatment. Two of the treatment-naïve patients required no further anti-VEGF injections at two years. The new device has received USA regulatory approval for an investigational clinical trial.