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Medical Devices / Submissions and Approvals

Ra Medical Systems Achieves FDA Clearance For Peripheral Artery Disease Treatment

May 31, 2017
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The FDA has granted marketing clearance to Ra Medical Systems for its DABRA System for peripheral artery disease treatment.

The device is a catheter and excimer laser system for the treatment of complex and diffuse arterial blockages in the lower vessels.

The single-use catheter produces a lumen while minimizing trauma to the vasculature. It is a full catheter tip forward cutter, without the “dead-space” of fiber optic bundle catheters.

The DABRA laser photochemically ablates arterial blockages, reducing calcium, thrombus and atheroma, minimizing downstream debris. The portable laser weighs about 100 pounds. — Cynthia Jessup

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