Cardiovascular Systems Reports First Patient Enrollment in Calcium 360 Degrees Clinical Trial

According to Cardiovascular, the calcium 360 degrees study will evaluate the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI's Diamondback 360 PAD System, a minimally invasive catheter for treating PAD anywhere in the leg. The first procedure was performed by Dr. Nicolas Shammas at Trinity Medical Center, Bettendorf, Iowa. Dr. Shammas is the research director of the Midwest Cardiovascular Research Foundation in Iowa. He and Dr. Russell Lam, Presbyterian Hospital, Dallas, are the study's co-principal investigators.

The Calcium 360 degrees trial will compare the effectiveness of the Diamondback 360 degrees to balloon angioplasty in treating atherosclerosis in the smaller vessels behind and below the knee (popliteal, tibial and peroneal). The study will enroll 50 patients at five investigational sites and follow patients for 12 months. The primary endpoint is 30 percent or less residual stenosis, or plaque remaining, with no dissection. In this study, Volcano Corp.'s intravascular ultrasound VH IVUS system is being used to acquire images which provide detailed, accurate measurements of plaque and vessels.

"Plaque buildup in the smaller vessels behind and below the knee is often calcified and difficult to treat with other devices and procedures," said Dr. Lam. "I am optimistic that data from the Calcium 360 degrees study will demonstrate that we can safely restore blood flow, assist in improving wound healing, prevent amputations and improve quality of life in patients treated with the Diamondback 360 degrees."

Calcium 360 degrees is the second study in CSI's 360 degrees Clinical Series, which is designed to demonstrate successful acute outcomes and durable long-term results with the Diamondback 360 degrees PAD System. The Calcium 360 degrees study complements the COMPLIANCE 360 degrees study, initiated in June 2009, another prospective, randomized study of 50 patients to evaluate use of the Diamondback 360 degrees in above-the-knee arteries.

CSI received FDA 510(k) marketing clearance for the Diamondback 360 degrees as a PAD therapy in August 2007 on the basis of data from the OASIS study, the first-ever prospective study evaluating a plaque removal system, which enrolled 124 patients at 20 sites. Acute outcomes demonstrated that the Diamondback 360 degrees device is safe and effective. Six-month results showed no amputations, and 97.5 percent of patients required no reintervention. Recently announced follow up on 64 patients demonstrated the long-term durability of treatment with the Diamondback 360 degrees , with a 100-percent limb salvage rate maintained and freedom from reintervention in 86.4 percent of patients after two years.

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