Carldbad, Calif.-based Ra Medical’s Dabra device uses laser radiation ablation to bore through blockages in affected arteries. It’s designed to minimize damage to the surrounding vessel tissue.
The 2,500-patient Results trial is designed to evaluate outcomes for patients treated for re-narrowing of the peripheral arteries after an initial procedure to remove the blockage. Patients are slated for two years of follow-up at six-month intervals, the company said
“Restenosis, or re-narrowing of an artery post-procedure, is a major problem for my patients,” principal investigator Dr. C.V. Ramana, of Oklahoma City’s NAADI Healthcare, said in prepared remarks. “In my experience, Dabra has provided a highly effective treatment, with minimal vascular trauma, which I believe leads to lower rates of restenosis and longer lasting results.”
“In my practice, we are seeing very positive clinical outcomes using Dabra,” added study chairman Dr. Rajesh Dave, of Camp Hill, Pa.’s Geisinger Holy Spirit Hospital. “The goal of this study is to demonstrate the lasting lumen patency achieved with this exciting new technology.”
“Our mission at Ra Medical Systems is to help physicians save patients’ limbs and lives,” CEO Dean Irwin said in a press release. “We believe the clinical study will demonstrate that patients do not have to return to their doctor to be re-treated for the same blockage, which benefits that patient and the healthcare system as a whole.”
Dabra won CE Mark approval in the European Union in October 2016 and landed 510(k) clearance from the FDA the following May. Ra Medical brought in more than $86 million in an initial public offering in October 2018.