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 360⁰ was successful in 98 percent of patients, with an acute procedural success rate of 94 percent. As part of its 360⁰ Clinical Series, CSI has completed enrollment in 11 peripheral and coronary studies at nearly 300 hospitals with more than 2,400 patients.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 and centers that will be involved in the ORBIT II trial; (ii) FDA approval to use the ViperSlide ® Lubricant in the ORBIT II study; (iii) CSI’s progress toward U.S. regulatory approval for a coronary application; (iv) the market opportunity of the coronary application; (v) CSI’s ability to repeat the outcomes of the ORBIT I trial in the ORBIT II trial; and (vi) the effectiveness of the Diamondback 360°, 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; the FDA process; 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., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Stealth 360°™, Diamondback 360 ® and Diamondback Predator 360 ® Orbital 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. The U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° in August 2007 and for the Stealth 360° in March 2011. To date, more than 37,000 PAD procedures have been performed using the Diamondback 360° in leading institutions across the United States. For more information, visit the company’s website at www.csi360.com. Product Disclosure The Stealth 360°™, Diamondback 360 ® and Diamondback Predator 360 ® Orbital PAD Systems 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. The Diamondback 360 ® System for use in coronary arteries is an investigational device and is limited by Federal (or United States) law to investigational use.