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Cardiovascular Systems Announces First Patients Treated with New Electric Orbital Atherectomy System in ORBIT II Coronary Trial

Tue, 07/03/2012 - 11:06am

 ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, today announced that two patients at two different hospitals were treated with its new, 6 French guide catheter-compatible, electric orbital atherectomy system. The treatments are part of CSI’s ORBIT II trial, which is now over 70 percent enrolled. ORBIT II is evaluating the safety and effectiveness of CSI’s orbital technology in treating calcified coronary arteries.

“The new lower profile system allows me more access site options, so I can treat a broader patient population.”

Dr. Rohit Bhatheja, an interventional cardiologist at Florida Hospital Orlando in Orlando, Fla., and Dr. Rakesh Shah, an interventional cardiologist at St. Mary Medical Center in Langhorne, Pa., enrolled the first patients with the new electric coronary system. Dr. Bhatheja said, “This new electric system is very easy to use, and the setup time only takes a few seconds.” Dr. Rakesh added, “The new lower profile system allows me more access site options, so I can treat a broader patient population.”

According to David L. Martin, CSI president and CEO, “Treating patients with our most advanced coronary system in the ORBIT II trial is a key accomplishment, as we work to secure a coronary indication in the United States. Using orbital technology in calcified coronary arteries may lead to a new treatment paradigm for more effective stent placement, avoiding the trauma and cost of retreatment or heart bypass surgery. Our technology showed excellent results in the ORBIT I feasibility trial, and we anticipate similar results in ORBIT II.”

CSI’s orbital technology is well suited for removing calcific and fibrocalcific plaque in coronary lesions. This new coronary system underscores CSI’s technology leadership in treating calcified arteries with a simpler design that gives physicians complete control of device operation. Additionally, the system uses CSI's orbital mechanism of action that protects healthy tissue while removing even the most difficult to treat plaque. The advanced, electric-powered handle features a power on/off button and speed selection controls conveniently positioned for ease of use and greater physician control. By eliminating the compressed air tank and separate speed controller of the previous coronary systems, CSI’s new system significantly reduces device set-up and lab-staff time.

CSI received unconditional FDA IDE approval for the ORBIT II study in April 2010, and more than 45 U.S. medical centers are enrolling patients. The company expects to complete patient enrollment early fall of 2012. Dr. Jeffrey Chambers, an interventional cardiologist with Metropolitan Cardiovascular Consultants, Minneapolis, is the principal investigator for the ORBIT II study. The primary endpoints of ORBIT II are based on a 30-day patient follow-up post procedure, and CSI expects to submit a Premarket Approval (PMA) application to the FDA soon after enrollment completion.

A coronary application of CSI’s orbital technology would open up a large, underserved opportunity for the company. CSI estimates coronary market potential to be in excess of $1.5 billion.

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 Diamondback Orbital Atherectomy System treats calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and addresses 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 Orbital Atherectomy System in August 2007. To date, more than 66,000 PAD procedures have been performed using CSI’s technology in leading institutions across the United States. CSI has also commenced its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.

For more information, visit the company’s website at www.csi360.com.

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