Cardiovascular Systems Completes Patient Enrollment in COMPLIANCE 360° Clinical Trial

Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), has completed patient enrollment in its COMPLIANCE 360° clinical trial, part of the company’s 360° Clinical Series. COMPLIANCE 360° is a prospective, randomized feasibility study to evaluate the treatment of peripheral arterial disease (PAD) above the knee using CSI’s Diamondback 360® System, a minimally invasive catheter for treating PAD anywhere in the leg. Dr. Raymond Dattilo, director of peripheral vascular intervention at the Kansas Heart and Vascular Center, Cardiology Consultants of Topeka, P.A., Topeka, Kansas, is the study’s principal investigator.

“We have now completed enrollment in both the COMPLIANCE 360° and CALCIUM 360° clinical trials – the first-of-their-kind, complementary initiatives that will provide physicians scientific data to confirm the value of the Diamondback 360° in achieving optimal patient outcomes,” said David L. Martin, president and CEO of Cardiovascular Systems. “Through these studies, we are also collecting 24-month economic data for informed clinical decisions.”

The COMPLIANCE 360° trial is comparing the benefits of removing plaque and improving vessel compliance above the knee with the Diamondback 360° followed by low-pressure balloon therapy versus treatment with high-pressure balloon inflation alone. The study has enrolled 50 patients at nine investigational sites and will follow patients for 12 months. Interventional cardiologists and vascular surgeons are participating in the study. The primary endpoint is six-month restenosis (measured by arterial Duplex ultrasound with PSVR >2.5), or TLR (including the need for bailout stenting at procedure time). In addition to collecting clinical outcomes, the COMPLIANCE 360° study will gauge the economic utility of both the Diamondback 360° and angioplasty procedures by assessing initial procedural costs as well as subsequent hospitalizations.

“Treatment with stents has significant shortcomings in the above-the-knee region, and we need more effective, durable options,” said Dr. Dattilo. “The Diamondback 360° has the ability to remove hard, calcified plaque and better achieve more uniform, circumferential lesion compliance for patients with above-the-knee PAD. The Diamondback 360° facilitates treatment of larger vessels by modifying plaque first, which typically allows for lower pressure adjunctive balloon therapy. Clinical data from the COMPLIANCE 360° trial will help the medical community better understand the potential benefits of treating PAD patients with this device.” Dr. Dattilo described the COMPLIANCE 360° trial in an article in the March 2010 issue of Endovascular Today.

COMPLIANCE 360° is part of CSI’s 360° Clinical Series to demonstrate successful acute outcomes and durable long-term results with the Diamondback 360°. In April 2010, CSI completed patient enrollment in its CALCIUM 360°, another prospective, randomized feasibility study in the series evaluating 50 patients treated with either the Diamondback 360° or angioplasty in arteries behind or below the knee. These studies build upon the already completed OASIS and OASIS Long Term studies that demonstrated the safety, effectiveness and durability of the Diamondback 360° device in treating peripheral vascular disease.

Safe Harbor

Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are intended to enjoy the protection of the safe harbor for forward-looking statements provided by that Act. For example, the statements in this press release regarding the expected benefits and results of the COMPLIANCE 360° study are forward-looking statements. These statements involve risks and uncertainties which could cause results to differ materially from those projected, including but not limited to the potential for unanticipated delays in enrolling medical centers and patients for the study; new data or events that may disrupt plans for this study; unexpected results or clinical outcomes in the COMPLIANCE 360° study and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing interventional treatment systems for vascular disease. The company's Diamondback 360® 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. As many as 12 million Americans suffer from peripheral arterial disease (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, and can lead to tissue loss and eventually limb amputation. In August 2007, the U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° as a therapy for PAD, and CSI commenced a U.S. product launch in September 2007. Since then, more than 25,000 procedures have been performed to-date using the Diamondback 360° in leading institutions across the United States. For more information visit the company's Web site at www.csi360.com.

Product Disclosure

The Diamondback 360® System is a percutaneous orbital atherectomy system 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.

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