Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII), announces the first patient enrollment in its prospective, randomized CALCIUM 360° clinical trial, part of the company’s 360° Clinical Series. The CALCIUM 360° 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 successfully 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.
“Balloon angioplasty, the current standard of care for endovascular treatment, may cause severe dissection, or cracking, in vessels with hardened plaque, which in turn could require placement of a stent,” said Dr. Shammas. “The Diamondback 360° may offer physicians an essential solution for effectively removing hardened plaque without a high rate of dissection and need for stenting in below-the-knee lesions. CALCIUM 360° will build on previous studies of the Diamondback 360° procedure, adding to our understanding of this unique technology.”
The CALCIUM 360° trial will compare the effectiveness of the Diamondback 360° 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 major dissection. In this study, Volcano Corporation’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° 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°.”
CALCIUM 360° is the second study in CSI’s 360° Clinical Series, which is designed to demonstrate successful acute outcomes and durable long-term results with the Diamondback 360° PAD System. The CALCIUM 360° study complements the COMPLIANCE 360° study, initiated in June 2009, another prospective, randomized study of 50 patients to evaluate use of the Diamondback 360° in above-the-knee arteries.
David L. Martin, president and CEO of Cardiovascular Systems, noted, “CSI is leading the way in collecting clinical data to advance the standard of care for PAD patients, save limbs and lives, and support evidence-based medicine. CALCIUM 360° focuses on changing the compliance of hardened plaque below the knee, where more effective, durable treatments are especially needed. Through this and our other evaluations, we are also collecting economic data to demonstrate the cost-effectiveness of the Diamondback 360° procedure ─ a vital consideration in this cost-conscious healthcare environment.”
CSI received FDA 510(k) marketing clearance for the Diamondback 360° 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° device is safe and effective. Six-month results showed no major 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°, 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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