Data from Cardiovascular Systems’ (CSI) (Nasdaq: CSII) Predator 360° prospective single-center clinical study titled, Use of Orbital Treatment in a High Volume Clinical Practice Modifies Non-Compliant Plaque to Deliver Durable Long-Term Results, presented today affirmed the procedural safety and efficacy, as well as the long-term durability, of the Predator 360 ® PAD System in treating peripheral arterial disease (PAD), or blockages in leg arteries. The poster occurred today at the 2011 Vascular Interventional Advances (VIVA) conference.

According to Principal Investigator Dr. Prakash Makam, Cardiovascular Research of Northwest Indiana, Munster, Ind., “Twelve-month data shows the Predator 360° is a durable solution, resulting in modified lesion compliance. This is reflected by short treatment times, low-pressure balloon inflations post orbital atherectomy treatment, and elimination of bailout stenting. The Predator’s unique orbital mechanism of action with differential sanding safely removes resistant plaque, reducing the need for high-pressure balloon inflation and stenting.”

The study enrolled 46 patients at a single U.S. site. Fifty-seven lesions, with an average blockage of 90 percent due to plaque buildup, were treated using the Predator 360 ° PAD System. Additionally, patients presented with symptoms that ranged from severe pain to minor tissue loss due to their blocked arteries. Patients underwent primary intervention with the Predator 360° orbital technology followed by adjunctive balloon inflations if necessary, as determined by the physician.

Bailout stenting was not needed as a result of the efficacy of orbital atherectomy technology. Use of the Predator 360° led to durable results with a low (10.9 percent) reintervention rate within 12 months. In contrast, balloon angioplasty typically requires much higher balloon inflation pressures in fibrotic and calcified plaques, and subsequent dissection rates range from 40 percent to 74 percent¹, with bailout stenting rates as high as 40 percent².

David L. Martin, CSI president and chief executive officer, noted: “Dr. Makam’s study confirms previous data that demonstrates our PAD therapy is safe and provides excellent long-term results. Small, calcified vessels represent an understudied and challenging treatment dilemma, and CSI is the only atherectomy company providing physicians with the clinical and scientific data needed to treat them. Prospective data accumulated to date confirm the clinical and economic relevance of CSI’s orbital technology to treat fibrotic and calcific vessels large and small, which was a previously untreatable disease. CSI continues to lead the way in collecting scientific PAD data through our ongoing active 360 ° Clinical Series program.”

Symposium Reviewed CSI Orbital TreatmentCSI technologies and data from the 360 ° Clinical Series studies were presented at a symposium, “Redefining the Algorithm for Outflow Therapy” today in conjunction with the 2011 VIVA Conference. Featured topics and speakers were:
  • The Importance of Evidence-Based Medicine
    • Dr. George Adams, Rex/UNC Healthcare (Raleigh, N.C.)
  • Change Compliance FirstTM: Optimizing Treatment Strategies for Femoropopliteal Disease
    • Dr. Raymond Dattilo, St. Francis Health Center (Topeka, Kan.)
  • Best Practices for Plaque Modification in Patients with Calcified Outflow – View full abstract
    • Dr. Prakash Makam, Community Hospital (Munster, Ind.)
  • Restoring Runoff in Patients at Risk of Amputation: Advanced Tips and Techniques
    • Dr. J.A. Mustapha, Metro Health Hospital (Wyoming, Mich.)
  • The Next Frontier in Endovascular Treatment
    • Panel discussion

At VIVA, CSI is demonstrating its orbital PAD systems at Booth No. 222.

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 °, Predator 360°, or Diamondback 360 ° devices, 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 °TM, Diamondback 360 ® and Predator 360 ® 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 55,000 PAD procedures have been performed using CSI's PAD systems 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 orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use 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 °TM, Diamondback 360 ® and Predator 360 ® 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.

References:
  1. Fitzgerald P. Contribution of Localized Calcium Deposits to Dissection After Angioplasty. Circulation 86 (1): 64-70.
  2. Laird J. Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the Superficial Femoral Artery and Proximal Popliteal Artery. Circulation.3(3): 267.

Editor’s Note: For background information and images, please go to www.csi360.com.

Copyright Business Wire 2010