Cardiovascular Systems, a medical device company that specializes in the treatment of vascular diseases, has enrolled the first patient in its COMPLIANCE 360° clinical trial. The prospective study will generate additional data on the effectiveness of CSI’s Diamondback 360° Peripheral Arterial System against above-the-knee lesions related to peripheral arterial disease (PAD). PAD is a vascular condition in which hardened plaque clogs up the foot or leg arteries, reducing blood flow, causing leg pain, and potentially leading to amputation. Approximately 8 to 12 million people in the U.S. are affected by PAD.
PAD can be treated using high-pressure balloon angioplasty, in which a balloon attached to a thin tube is inserted through the skin and expanded to open up the artery. However, this procedure often damages the large diseased vessels above the knee. The COMPLIANCE 360° study will compare the benefits of high-balloon angioplasty to treatment with the Diamondback 360 system followed (in some cases) by low-pressure balloon angioplasty. The Diamondback 360° uses a rotating “crown” to sand away plaque, providing an alternative to surgery or amputation. The device received 510(k) clearance from the U.S. Food and Drug Administration in 2007. Since the product’s launch two years ago, about 500 hospitals across the country have adopted the device to treat PAD.
Cardiovascular Systems, based in St. Paul, Minn., plans to enroll 50 patients in the COMPLIANCE 360° study. Patients will be followed for 12 months.
Without early detection, PAD can become life-threatening. BioMedix has developed the PADnet Disease Management System for the easy diagnosis of PAD. Their system tests a variety of factors, including blood pressure measurements and venous refill time. HyperMed ‘s OxyVu is an imaging system to diagnose and monitor PADS.