Salutaris Medical Devices (SalutarisMD) announced that during its upcoming presentation at the Ophthalmology Futures European Forum on September 8, the company will introduce its new generation, commercial ready, episcleral brachytherapy applicator system.
The presentation by Dr. Laurence Marsteller, CEO, will discuss how the new SalutarisMD system (SMD-DA) is designed to deliver improved dosimetry to wet AMD lesions and improved ease of use for retinal surgeons. The company will also display the system at its exhibitor’s booth. ISO audits for certification and CE application are underway and the company expects to receive ISO 13485 certification and the CE Mark on the commercial product by year end.
The company recently received US regulatory approval for an upcoming clinical study utilizing the new and improved device. The company has successfully completed a previous study with a first generation clinical device. While that study was not intended to be extrapolated for statistical significance, individual subject results were tracked. In three of the four treatment-naïve patients and one of the two chronically treated wet AMD patients, best corrected visual acuity (BCVA) improved at two years following SMD-1 treatment (range: +4 to +25 ETDRS letters). In addition, two treatment-naïve patients did not require any further anti-VEGF injections during the following two years.
As wet AMD is the leading cause of blindness worldwide, there is an urgent and compelling need for new therapies that improve visual outcomes and lower the burden of care. Dr. Laurence Marsteller commented that, “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.”