FDA grants approval for CSI to complete enrollment in ORBIT II IDE coronary clinical trial

Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII) has received FDA approval to complete enrollment of 429 patients in its ORBIT II Investigational Device Exemption (IDE) clinical trial for a coronary application for its Diamondback 360^® System. The approval came following FDA review of data from the first 50 cases, as called for in the trial protocol. The ORBIT II trial is evaluating the safety and effectiveness of CSI's orbital technology in treating calcified coronary arteries. CSI has also received conditional approval from the FDA to use ViperSlide^® Lubricant in the ORBIT II study.

"Approval to proceed with ORBIT II patient enrollment is a major milestone in obtaining a U.S. regulatory approval for a coronary application - a significant market opportunity for CSI," said David L. Martin, president and CEO of Cardiovascular Systems. "The Diamondback 360°'s orbital mechanism of action has already demonstrated it is especially well suited for treating small, calcified lesions in leg arteries. Use of the Diamondback 360° device in small, calcified coronary arteries may facilitate more effective stent placement, or avoid the trauma and cost of heart bypass surgery. This was demonstrated by the strong safety and efficacy data from our ORBIT I coronary feasibility trial, and we are confident we will have similar results in ORBIT II."

The Diamondback 360° is designed to be well suited for removing calcific and fibrocalcific plaque in coronary lesions. The system uses a diamond-coated crown with a unique orbital mechanism of action to sand and remove hardened plaque, which may facilitate more effective stent placement and restoration of blood flow in the coronary arteries. The orbital action also allows continuous saline and blood flow through the lesion, which may be advantageous during treatment. CSI's proven orbital mechanism action protects healthy vessel tissue while removing even the most difficult plaque to treat.

CSI received unconditional FDA IDE approval for the ORBIT II study in April 2010. As many as 50 U.S. medical centers are expected to participate in ORBIT II. Dr. Jeffrey Chambers, an interventional cardiologist with Metropolitan Cardiovascular Consultants, Minneapolis, is the principal investigator for the ORBIT II study. In the initial ORBIT I coronary study of 50 patients in India, the Diamondback 360° was successful in 98 percent of patients, with an acute procedural success rate of 94 percent. As part of its 360° Clinical Series, CSI has completed enrollment in 11 peripheral and coronary studies at nearly 300 hospitals with more than 2,400 patients.