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June 20, 2019

RESULTS Registry Will Evaluate 2-Year Outcomes With Ra Medical's DABRA Excimer Laser System

June 19, 2019—Ra Medical Systems, Inc. announced it is conducting a study to demonstrate the effectiveness of the company's DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) excimer laser photoablation system to deliver long-lasting results and a low reintervention rate for patients with peripheral artery disease. The DABRA system nonthermally, photochemically ablates channels in vascular blockages with minimal vascular trauma.

According to the company, the RESULTS study will gather revascularization rates and clinical outcomes data with the DABRA system at 2 years posttreatment. The multisite registry study will include 2,500 patients with Rutherford classification of 2–6 enrolled at up to 50 hospital or office-based lab sites in the United States. Each patient will receive follow-up at 6-month intervals for 2 years.

C.V. Ramana, MD, will serve as Principal Study Investigator of RESULTS. Rajesh Dave, MD, is Study Chairman. Dr. Ramana practices at NAADI Healthcare in Oklahoma City, Oklahoma. Dr. Dave is Chairman of the Department of Cardiology, Geisinger Holy Spirit Hospital in Camp Hill, Pennsylvania.

In the company's press release, Dr. Ramana commented, “Restenosis, or renarrowing of an artery postprocedure, is a major problem for my patients. 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.”

Dr. Dave stated, “In my practice, we are seeing very positive clinical outcomes using DABRA. The goal of this study is to demonstrate the lasting lumen patency achieved with this exciting new technology.”

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June 21, 2019

CDRH Provides Statement on Efforts to Increase Transparency in Medical Device Reporting

June 21, 2019

CDRH Provides Statement on Efforts to Increase Transparency in Medical Device Reporting