Salutaris Medical Devices (SalutarisMD) is set to introduce new generation episcleral brachytherapy applicator system.
The new system is intended to treat patients with wet age-related macular degeneration (wet AMD).
According to the company, the firm expects to receive ISO 13485 certification and the CE mark approval for the new system by the end of this year.
Recently, the firm secured US regulatory approval for the new clinical study, which will assess the new device.
SalutarisMD already completed a previous study with a first generation clinical device, in which individual subject results have been tracked.
The firm’s patented technology integrates a minimally invasive single-use brachytherapy procedure, which can be carried out in an outpatient setting in around 15 minutes.
The method delivers ocalized tissue irradiation that is carried out under the direct care and expertise of a retina specialist.
SalutarisMD CEO Laurence Marsteller said: “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.”
The company will showcase the new episcleral brachytherapy applicator system at the Ophthalmology Futures European Forum.