Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announced today that its CALCIUM 360° Study, the first-of-its kind prospective, randomized feasibility study, demonstrated the safety and effectiveness of plaque modification with the Diamondback 360 ® PAD System versus the standard of care treatment (balloon angioplasty) in below-the-knee arteries. This study contributes to a large and growing body of clinical evidence from 1,200 patients in nine clinical trials demonstrating that the Diamondback 360° can predictably treat peripheral arterial disease (PAD) safely and effectively anywhere in the leg. The Diamondback System, developed and manufactured by CSI, is a minimally invasive catheter system that removes hardened plaque to restore blood flow in peripheral arteries. Dr. Nicolas Shammas, Trinity Medical Center, Bettendorf, Iowa, principal investigator of the CALCIUM 360° Study, will present the acute results in a Wednesday, September 22 poster session (No. 411, Hall A) from 1 to 3:30 p.m. at the 22 nd Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C., sponsored by the Cardiovascular Research Foundation. Two additional studies highlighting the acute safety and efficacy advantages of the Diamondback 360° will be presented during the same poster session:
CALCIUM 360° Study Shows Improved Results Over the Current Standard of CareThe CALCIUM 360° Study randomized 50 patients with critical limb ischemia under a common protocol to either orbital treatment with the Diamondback 360° or balloon angioplasty. The primary endpoint of device success of ≤ 30 percent residual stenosis with no dissection Type C-F, as determined by operator visualization angiographically, was met in 92.6 percent of those treated with the Diamondback 360° and 78.8 percent of those treated with balloon angioplasty (p < 0.001). Primary treatment in the orbital arm was followed by low-pressure balloon inflation, while the physician’s standard protocol for balloon therapy was used in the alternative arm. Ninety-six percent of the patients had symptoms of critical limb ischemia (Rutherford classes 4-6), and 94 percent had moderately or severely calcified lesions. Six- and 12-month clinical and economic outcomes will be reported as the data becomes available. “The Diamondback 360° is particularly effective in changing the compliance of calcified lesions prior to low-pressure balloon angioplasty,” said Dr. Shammas. “Traditionally, patients with PAD have been treated with high-pressure balloon angioplasty, which is associated with a high rate of dissection and bailout stenting. With the Diamondback 360°, patients with calcified arteries now have an ideal option for restoring flow to heal wounds, save legs and keep patients walking ─ without leaving metal stents in the leg or having to undergo bypass surgery.” CONFIRM DIAMONDBACK Registry Demonstrates Safety, Efficacy Results in Challenging, Real-World Population The CONFIRM DIAMONDBACK Registry further validates the acute safety and efficacy of the Diamondback 360° System in a real-world setting. This prospective, single-arm study enrolled 728 patients by 84 physicians at 57 centers. All patients considered candidates for treatment with the Diamondback 360° by the physician were enrolled consecutively. “This registry demonstrates the benefits of changing lesion compliance with the Diamondback 360°, followed by low-pressure adjunctive balloon angioplasty, if desired, in a very large and challenging patient cohort,” said Dr. Dattilo. “Data from this study show that the entire leg can quickly, safely and effectively be treated by a multitude of physicians with variable experience and treatment philosophies.” CONFIRM results include a low rate of procedural events (0.5 percent perforations, 1.2 percent abrupt closure/no flow and 0.7 percent macro embolization), predictable plaque removal with a final residual stenosis of 10.5 percent, and a low bailout stent rate due to dissection (2.2 percent).
CLEAR 360° Study Provides Additional Safety DataThe potential for hemolysis (a breakdown of red blood cells) as a side effect of orbital atherectomy treatment was evaluated for its clinical significance in the CLEAR 360° Study. Results of 31 patients at four enrolling centers showed that no clinically significant hemolysis was found in any subject. 360° Clinical Series of Studies Under Way CSI’s 360° Clinical Series — including the CONFIRM, CALCIUM 360° and CLEAR 360° Studies — is designed to demonstrate successful acute outcomes, durable long-term results and the economic feasibility of orbital PAD treatment. Other studies under way include the COMPLIANCE 360° Study to evaluate the effectiveness of changing lesion compliance with the Diamondback 360° versus treatment with balloon angioplasty in calcified above-the-knee arteries and the CONFIRM PREDATOR registry to collect information on the newly released Diamondback Predator 360™ PAD System. About the Cardiovascular Research Foundation The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1990, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in the subspecialty of interventional cardiology and endovascular medicine. For more information, please visit www.crf.org. 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 ® and Diamondback 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. 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, nearly 30,000 procedures have been performed using the Diamondback 360° in leading institutions across the United States. For more information visit the company’s Web site at www.csi360.com. 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 provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding CSI’s ongoing and future clinical trials; 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 clinical trials; the performance of the Diamondback System and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. 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.
Product DisclosureThe Diamondback 360 ® PAD System and Diamondback Predator 360™ PAD System 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.