EndocrinologyCardiovascular Systems Announces First Patient Enrolled In COMPLIANCE 360 Degree Clinical Trial
Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, announced today that the first patient has been enrolled in the COMPLIANCE 360 degree clinical trial. This prospective, randomized study will generate additional data on patient outcomes achieved in treating lesions above the knee with CSI"s Diamondback 360°® Peripheral Arterial System, a minimally invasive catheter for treating peripheral arterial disease (PAD).
COMPLIANCE 360° will compare the benefits of first modifying calcified plaque with the Diamondback 360° system followed by low-pressure balloon inflation if needed, versus the use of high-pressure balloon angioplasty alone in calcified lesions above the knee. Treatment with only high-pressure balloon angioplasty often damages large diseased vessels above the knee. Initial treatment with the Diamondback 360° could reduce the level of balloon pressure required to finish opening the vessel. The COMPLIANCE 360° study calls for enrolling 50 patients at five U.S. medical centers. Patients will be followed for 12 months, and an independent angiography core lab will verify results.
"CSI is devoted to clinical research that leads to innovative solutions to conquer PAD and keep patients walking without pain," said David L. Martin, CSI president and chief executive officer. "The physical, emotional and financial toll of more than 100,000 amputations annually in the United States is unacceptable. Our tool in doctors" hands has successfully treated more than 15,000 patients in less than two years since our FDA clearance. We are confident that the Diamondback 360° offers an effective solution to address PAD, giving patients and their loved ones new hope. COMPLIANCE 360° is the first of several post-market studies CSI is sponsoring to provide physicians with the clinical data they need. We plan to launch CALCIUM 360°, a study evaluating treatment with the Diamondback 360° in calcified lesions below the knee, in the coming months."
CSI received FDA 510(k) marketing clearance for the Diamondback 360° as a PAD therapy in August 2007 on the basis of data from the OASIS study, a prospective study which enrolled 124 patients at 20 medical centers. Since then, nearly 500 hospitals have adopted the Diamondback 360° system.
Dr. Ravish Sachar, an interventional cardiologist at WakeMed Health and Hospital in Raleigh, N.C., who enrolled the first patient in the COMPLIANCE 360° trial, commented, "The Diamondback 360° represents a viable treatment option for patients who previously have had limited options. Treating this disease can be very challenging due to the frequency of non-compliant, calcified plaque resulting from diabetes, smoking or renal failure. It has long been understood that high-pressure balloon angioplasty alone in these types of lesions can lead to vessel damage, and this study will help provide insight into the benefits of plaque modification prior to angioplasty."
Dr. Ray Dattilo, COMPLIANCE 360° principal investigator and director of peripheral interventions at St. Francis Hospital, Topeka, Kan., added, "In this difficult healthcare environment, with increasing costs and not enough dollars to go around, it is especially important to demonstrate that a new technology is better than the current standard of care. CSI understands that spending scarce healthcare dollars wisely is a necessity, and the company is willing to devote res to a randomized trial. The Diamondback system, supported by sound clinical data, could create a paradigm shift in the treatment of PAD."
Cardiovascular Systems, Inc.