May 26, 2010 - Pivotal Study Evaluating the Clinical Benefits of Treating Calcified Coronary Lesions with the Diamondback 360° System – Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announces the first patient enrollment in its ORBIT II Investigational Device Exemption (IDE) clinical trial to evaluate the safety and effectiveness of its Diamondback 360® System in treating coronary arteries. The patient was treated by Dr. P.K. Khanna, an interventional cardiologist with Eisenhower Medical Center in Palm Springs, Calif. Dr. Khanna also treated patients in the 2008 ORBIT I coronary study of 50 patients in India. ORBIT I showed that the Diamondback 360° was successful in 98 percent of patients with calcified lesions, with an acute procedural success rate of 94 percent.“Severely calcified coronary lesions have frequently been excluded from other clinical studies over the past decade because they are a clinical challenge for coronary interventions,” Dr. Khanna said. “I believe that the Diamondback 360° is an essential advancement in treating patients with this type of disease. This easy-to-use tool should prove — through the ORBIT II trial — to be safe and effective in treating calcified lesions in order to facilitate stent placement.”
The ORBIT II study advances CSI’s progress toward U.S. regulatory approval for a coronary application and a significant market expansion. CSI received unconditional FDA IDE approval for the ORBIT II study in April 2010. The pivotal trial will initially enroll up to 100 patients, with the potential to enroll up to 429 patients... Cardiovascular Systems' Press Release -
