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Saturday, October 23, 2021

MEDICAL DEVICE NEWS MAGAZINE

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HomeRa Medical SystemsDABRA Begins First Commercial, FDA-Cleared, In-Patient Use Reports Ra Medical Systems
HomeRa Medical SystemsDABRA Begins First Commercial, FDA-Cleared, In-Patient Use Reports Ra Medical Systems

DABRA Begins First Commercial, FDA-Cleared, In-Patient Use Reports Ra Medical Systems


Now Treating Patients with Peripheral Artery Disease in the United States

Ra Medical Systems, today announced the commercial launch in the United States of the Company’s groundbreaking DABRA™ System for treatment of Peripheral Artery Disease. This follows FDA clearance earlier this week.

Dr. Athar Ansari of the California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient today, performing the first ever DABRA case on arterial blockages via brachial artery access.

Additionally, Dr. Raghotham Patlola of the Louisiana Cardiovascular & Limb Salvage Center will present new data on DABRA at the New Cardiovascular Horizons (NCVH) Conference in New Orleans, La., on Friday, June 2, 2017, highlighting the efficacy and safety of this treatment to date.

Dr. Patlola reports: “My patients have a high rate of Peripheral Artery Disease, many with a high likelihood of limb amputation. To help them, I have worked with Dean Irwin and Ra Medical Systems to make DABRA a reality, performing the most DABRA cases to date. It is a two-in-one – you cross the blockage and remove the plaque from the artery – and with FDA clearance, starting today, DABRA will be my go-to choice to provide my patients with the safest and most effective, state-of-the-art technology to cross and treat arterial blockages.”

DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) changes the paradigm of vascular treatments clinically and economically, continuing Ra Medical Systems’ decade-long successful track record of delivering better, safer, faster and less-expensive solutions to treat complex and chronic medical conditions. Compared to other treatments for arterial blockages, Ra Medical Systems’ DABRA has shorter procedure times, better patient outcomes and is less expensive. Combined with its safety profile and versatility, these DABRA advantages may reduce the costs that are associated with treating Peripheral Artery Disease and ultimately lead to greater patient access to, and success with, interventional procedures.

Dr. Patlola’s presentation showcases DABRA’s 95 percent success rate and top-notch safety profile, with zero adverse events, in the clinical study. The study also demonstrates the ease with which DABRA was used in a variety of catheter labs settings, its quick set-up and procedure time and its efficacy on all types of lesions.

“DABRA enables me to treat my patients more efficaciously and at a lower cost than other devices,” added Dr. Patlola. “I am thrilled to present the study data to my peers at New Cardiovascular Horizons so that more interventionalists can offer their patients access to this limb-saving device.”

Peripheral Artery Disease is the leading cause of limb amputations. More than 200 million people worldwide, including approximately 8.5 million Americans, suffer from Peripheral Artery Disease, a life-threatening condition in which the arteries that carry blood from the heart to the legs and arms narrow and become blocked. In the U.S. and Europe, Peripheral Artery Disease is responsible for approximately 240,000 amputations every year. Nearly one-quarter of these patients die within 30 days and almost half within a year of their limb amputation.

Dean Irwin, CEO, Ra Medical Systems, concluded, “The DABRA system is a win-win-win for patients, physicians and the healthcare system, offering all participants better clinical and economic outcomes in the treatment of Peripheral Artery Disease. Our clinical study investigators say that DABRA is a game-changer, and we are thrilled that this week’s FDA clearance enables us to make it available to patients across the U.S.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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