Acute data from Cardiovascular Systems’ (CSI) (Nasdaq: CSII) prospective, randomized COMPLIANCE 360° clinical trial was presented today at the American College of Cardiology’s (ACC) 60 th Scientific Session in New Orleans. The study directly compared the Diamondback 360 ® Orbital PAD System versus balloon angioplasty in treating above-the-knee peripheral arterial disease (PAD), or blockages in leg arteries.

COMPLIANCE 360° acute results (ACC i2 Poster #507) showed that the Diamondback 360° Orbital PAD System can achieve far superior acute results in treating calcium-containing femoropopliteal plaque by improving lesion compliance through a unique technology known as differential sanding, without the need for stent placement.

According to Principal Investigator Dr. Raymond Dattilo, St. Francis Health Center, Topeka, Kan., “The acute data from the COMPLIANCE 360° trial shows treatment with the Diamondback 360° leads to better luminal gain, improved lesion compliance (as reflected in lower balloon pressures post treatment with the Diamondback 360°) and a marked reduction in bailout stenting. The Diamondback’s unique orbital mechanism of action with differential sanding safely removes calcified plaque, reducing the need for high-pressure balloon angioplasty and stenting.”

David L. Martin, CSI president and chief executive officer added, “Our commitment to clinical rigor is providing physicians with the clinical and scientific data needed to support their treatment decisions and provide optimal patient outcomes. We are challenging old paradigms by going head-to-head against balloon therapy, which has previously been considered the standard of care. We now have acute results from 100 patients in two randomized studies — COMPLIANCE 360° and CALCIUM 360° — that demonstrate the unrivaled success of our orbital technology.” The CALCIUM 360° trial is evaluating the use of Diamondback 360° in treating calcified lesions below the knee.

Acute data showed treatment with the Diamondback 360° generated superior outcomes with fewer complications, as follows:
Acute Results from COMPLIANCE 360° Clinical Trial
        Diamondback 360°    

BalloonAngioplasty
   

StatisticalSignificance
 
  Met angiographic endpoint     82.4% of lesions     17.9% of lesions     p < 0.0001  
 

Maximum balloon inflation pressure(proxy for lesion compliance)
    3.8 atms     8.9 atms     p < 0.0001  
  Lesions requiring stents     2 (5.9%)     22 (78.6%)     p < 0.0001  

The COMPLIANCE 360° study enrolled 50 patients at nine U.S. sites. All patients had been diagnosed with calcium-containing lesions above the knee with ≥ 70 percent stenosis. Additionally, they exhibited Rutherford class 2 to 4 symptoms, that is, mild to severe pain due to blocked arteries. Patients were equally randomized to two groups: balloon angioplasty alone versus treatment with the Diamondback 360°, followed by low-pressure balloon angioplasty (up to 4 atmospheres), if needed, with the angiographic endpoint of a residual stenosis of ≤ 30 percent without bailout stenting.

COMPLIANCE 360° patients will have clinical follow up at one, six and 12 months, along with duplex scanning and Ankle Brachial Index evaluations, an indication of blood flow through the foot. Longer term results will be reported as they become available.

COMPLIANCE 360° is part of CSI’s 360° Clinical Series — clinical studies designed to demonstrate successful acute outcomes, durable long-term results and the economic feasibility of orbital PAD treatment. CSI is leading the industry in providing physicians the clinical and scientific data needed to support their treatment decisions and provide optimal patient outcomes. The results of the prospective data accumulated to date confirm the clinical and economic relevance of CSI’s orbital technology in calcific vessels large and small, and in previously untreatable disease.

About Peripheral Arterial DiseaseAs many as 12 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.

Millions of patients with PAD may benefit from treatment with the Stealth 360° and Diamondback 360°, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to a guide wire, which sands away plaque while preserving healthy vessel tissue, or medial integrity — a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.

About Cardiovascular Systems, Inc.Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Stealth 360°™, Diamondback 360 ® and Diamondback Predator 360 ® Orbital PAD Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° in August 2007 and for the Stealth 360° in March 2011. To date, more than 37,000 PAD procedures have been performed using the Diamondback 360° in leading institutions across the United States.

CSI has also commenced its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its Diamondback 360° System in treating coronary arteries. The coronary system is under clinical investigation and is currently not commercially available in the United States.

For more information, visit the company’s website at www.csi360.com.

Product DisclosureThe Stealth 360°™, Diamondback 360 ® and Diamondback Predator 360 ® Orbital PAD Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.

Editor’s Note: For background information and images, please go to http://pub.psbpr.com/CSI/mediakit-2010/newsroom/Default.aspx.

Copyright Business Wire 2010