Medical device maker Ra Medical Systems (Carlsbad, CA), which has developed an excimer laser treatment for cardiovascular and dermatological diseases, has received CE Mark approval for its DABRA atherectomy system with catheter and Pharos excimer laser phototherapy system to treat psoriasis, vitiligo, and other skin diseases. The approval allows the devices to be sold in the European Union and all countries that recognize the CE Mark.
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Peripheral artery disease (PAD) is a circulatory condition characterized by narrowing of the peripheral arteries, resulting in limited blood supply to the stomach, legs, arms, and head. This disease is similar to coronary artery disease in its nature and prevalence worldwide.
Atherectomy is the removal of the plaque from the arteries, and it differs from angioplasty in which the plaque is not removed and is a minimally invasive endovascular way to treat patients with PAD.
The first DABRA cases in Europe are expected to be performed in 2016. The company is currently nearing completion of its U.S. investigational device exemption (IDE) study to support FDA clearance.
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