Cardiovascular Systems Enrolls First Patient in ORBIT II Coronary Clinical Trial

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.

“Our commitment to clinical rigor continues to advance with the recent completion of patient enrollment for both the CALCIUM 360° and COMPLIANCE 360° post-market peripheral studies, and now with the initiation of the ORBIT II coronary study,” said David L. Martin, president and CEO of Cardiovascular Systems. “The ORBIT II trial is another scientific step in obtaining irrefutable proof to establish the Diamondback 360° as an advantageous treatment alternative in both coronary and peripheral arterial disease (PAD). Our device has been instrumental in providing more than 25,000 patients and their families a new option for treating PAD.”

“This is the start of a new era in the treatment of coronary artery disease,” said Dr. Jeffrey Chambers, an interventional cardiologist with Metropolitan Cardiovascular Consultants, Minneapolis, and the principal investigator for the ORBIT II study. “We believe that the Diamondback 360° System will broaden our ability to safely and effectively treat more challenging patients.”

The Diamondback 360° is distinctively designed to remove calcific and fibro-calcific plaque in coronary lesions thereby facilitating effective stent placement and restoring flow. With a diamond-coated crown and unique orbital mechanism of action, the system removes hardened plaque while allowing continuous saline and blood flow through the lesion, which may be advantageous during treatment.

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, statements in this press release regarding (i) the number of patients that will be involved in the ORBIT II trial; (ii) CSI’s progress toward regulatory approval for a coronary application; (iii) CSI’s significant market expansion; (iv) CSI’s optimism about the outcomes in a coronary application through the ORBIT II study; and (v) that the ORBIT II study is a scientific step in obtaining irrefutable proof to establish the Diamondback 360° as an advantageous treatment alternative in both coronary and peripheral arterial disease, 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 studies; new data or events that may disrupt plans for these studies; unexpected results or clinical outcomes in the ORBIT II trial 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., (CSI) (Nasdaq: CSII) based in St. Paul, Minn., is a medical device company focused on providing clinically proven, safe and effective interventional solutions for vascular disease. The company’s Diamondback 360® System removes calcified and fibrotic plaque in small and large peripheral vessels, and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. In August 2007, the U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° as a therapy for PAD (peripheral arterial disease), and CSI commenced a U.S. product launch in September 2007. Since then, more than 25,000 procedures have been performed using the system. For more information visit the company’s Web site at www.csi360.com.

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