ST. PAUL, Minn. & CHICAGO--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), today presented 12-month data from the COMPLIANCE 360° study of severely calcified above-the-knee lesions at the American College of Cardiology’s (ACC) 61st Annual Scientific Session. Dr. Raymond Dattilo, St. Francis Health Center, Topeka, Kan., principal investigator of the study, presented the long-term data (Abstract Presentation #1123-37) demonstrating that strong acute results translate into positive clinical outcomes at 12 months.
COMPLIANCE 360° enrolled 50 patients (with 65 lesions) at nine U.S. sites. Patients had calcified above-the-knee lesions greater than or equal to 70 percent, and were equally randomized to PTA alone versus therapy with the Diamondback Orbital Atherectomy System. Click here to read the full abstract.
Dr. Dattilo presented the following 12-month data:
|Diamondback Arm||PTA Arm|
|(25 pts)||(25 pts)|
≤30% residual stenosis without bailout stent placement
|92.1% of 38 lesions||21.4% of 28 lesions|
2 of 25 patients
21 of 25 patients
Mean maximum balloon pressure:
(p < 0.0001) (measure of lesions compliance)
|3.97 atm||9.15 atm|
|Percentage of patients free from target lesion revascularization (TLR) or duplex ultrasound restenosis at 12 months:||
15 of 20 patients
16 of 21 patients
Dr. Dattilo noted, “At 12 months, data from COMPLIANCE 360° shows outcomes, treating calcified lesions above-the-knee, consistent with other available data regarding the efficacy of this therapy. Vessel preparation with CSI’s Diamondback Orbital Atherectomy System, through compliance change, enables low-pressure adjunctive balloon inflation compared to the high pressures required in the PTA arm. Favorable acute angiographic results led to sustained patency at 12 months in the Diamondback arm that is comparable to PTA with adjunctive stent usage (only 8 percent vs. 84 percent of patients required stenting in each arm, respectively). Decreasing the need for adjunctive stenting preserves future treatment options for patients. Evidence continues to build that we can achieve positive clinical outcomes by changing lesion compliance and decreasing acute vessel injury with CSI’s Diamondback Orbital Atherectomy System.”
David L. Martin, CSI president and chief executive officer, added: “CSI is focused on treating patients with calcified disease in their arteries. The prevalence of arterial calcium is high in patients over 65 years of age who are diabetic, and/or have renal insufficiency. We are excited to offer both patients and payors a clinically proven product that provides durable outcomes. Our technology is safe, durable, and routinely treats calcium in less than 2 minutes of device run time.”
About Peripheral Arterial Disease
As 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 Diamondback Orbital Atherectomy System, a minimally invasive catheter system developed and manufactured by CSI. This system uses 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 Diamondback Orbital Atherectomy System treats calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and addresses 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 Orbital Atherectomy System in August 2007. To date, more than 61,000 PAD procedures have been performed using CSI’s technology 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.
The Diamondback Orbital Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The system is 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.