Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), shared 12-month data from the COMPLIANCE 360° study of severely calcified above-the-knee lesions at the New Cardiovascular Horizons Annual Conference on Saturday, June 9, 2012. Dr. Barry Weinstock, Interventional Cardiologist, Orlando Regional Medical Center, Winter Park, Fla., presented data demonstrating positive outcomes and cost comparisons to the widely used percutaneous transluminal angioplasty (PTA).

The COMPLIANCE 360° is a prospective, randomized study of 50 patients (with 65 lesions) at nine U.S. sites. Patients had calcified above-the-knee lesions greater than 70 percent and were equally randomized to PTA alone versus a therapy with the Diamondback™ Orbital Atherectomy System (Diamondback) with adjunctive PTA.

Important outcomes:
  • Study shows that by avoiding stents and reducing restenosis saves money - approximate incremental cost effectiveness of the Diamondback group vs. the PTA group at six months was $5,264 per additional acute adjunctive stenting or restenosis avoided.
  • The PTA arm required bail-out stenting in 84% of the procedures to achieve results equivalent to the Diamondback arm.
  • Diamondback procedures had lower dissection rates and reduced bail-out stenting, thus preserving future treatment options.

Key findings:
Diamondback Arm PTA Arm
25 patients/ 25 patients/
      38 lesions     27 lesions
Average number of stents placed:



(p 0.0001)


Average number of balloons used:



(p = NS) (measure of lesions compliance)


Percentage of patients free from acute adjunctive 72.7% 8.3%
stenting and restenosis at 6 months: (16 of 22 patients) (2 of 24 patients)

(p 0.0001)

David L. Martin, CSI president and chief executive officer, said, “Our goal is to provide top-quality, cost effective, treatment options for clinicians who treat patients with calcified lesions. The additional clinical data provided by the COMPLIANCE 360° study demonstrates our commitment to this effort and the results support using the Diamondback system as a primary therapy in the treatment of calcium.”

Also presented was information from Dr. Jihad Mustapha, Interventional Cardiologist, Metro Health Hospital, Wyoming, Mich., exploring how endovascular treatment with the Diamondback Orbital Atherectomy System may have advantages in modifying calcified lesions to allow lower pressure adjunctive balloon, less need for bailout stenting and improved patient outcomes. Dr. Mustapha highlighted real-world clinical experience demonstrating that treatment with CSI’s orbital technology, with its unique mechanism of action, prevents vessel wall damage and preserves the media, leading to better patient outcomes.

About Peripheral Arterial DiseasePAD is a life-threatening condition where a fatty material called plaque builds up on the inside walls of the blood vessels that carry blood from the heart to legs and arms. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow to the legs. The risk of PAD increases if a person has one or several of the following: high blood pressure, abnormal cholesterol levels, diabetes, or personal history of heart disease, heart attack or stroke. PAD affects an estimate 8-12 million in the United States. The disease prevalence increases with age and 12-20 percent of Americans age 65 and older (4.5 to 7.6 million) suffer from PAD symptoms. As the U.S. population ages, the prevalence range could reach 9.6 to 16 million in those age 65 and older and 19 million overall by 2050.

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 66,000 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

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