Ra Medical is looking to get some long-term data on its laser treatment for Peripheral Artery Disease. The Carlsbad, CA-based company is conducting a clinical study that will gather data for two years, post-treatment with the Dabra Excimer Laser System.
The REvascularization RateS and Clinical OUtcomes with DABRA Laser: A Long-Term 2-year Study(RESULTS)is a multi-site registry trial. It includes up to 50 U.S. hospital or office-based lab sites and 2,500 patients with Rutherford Classification 2 to 6. Each patient will receive follow-up at six-month intervals.
“In my practice, we are seeing very positive clinical outcomes using Dabra,” Rajesh Dave, MD., study chairman said in a release. “The goal of this study is to demonstrate the lasting lumen patency achieved with this exciting new technology.”
Dabra was launched in 2017 and unlike many mechanical, acoustic, or thermal treatments for peripheral artery disease that may damage the arterial wall, the device treats blockages with minimal vascular trauma.
“Our mission at Ra Medical Systems is to help physicians save patients’ limbs and lives,” Dean Irwin, CEO, said in a 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.”