Salutaris Medical Devices, Inc. announced the first subject was treated in a multi-center clinical trial investigating the use of its ophthalmic brachytherapy device to treat neovascular Age-related Macular Degeneration (nAMD) on May 23, 2018. Dr. Gregg Kokame, Principal Investigator (PI) at the clinical site in Honolulu successfully performed the first procedure using the SMD-DA device on May 9, 2018. The procedure was performed without complication and well tolerated by the subject.
The trial, “A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration”, has the primary objective to determine the safety, including surgeon ease of use and subject tolerability, of the SMD-DA system concomitant with an anti-VEGF treatment regimen. Further details are posted on www.clinicaltrials.gov (identifier NCT 02988895)