News | June 12, 2014

Cardiovascular Systems Enrolls First Patient in Study of New Atherectomy System

Study to assess safety and efficacy of new coronary micro crown

June 12, 2014 — Cardiovascular Systems Inc. (CSI) announced that the first patient has been enrolled in its Coronary Orbital Atherectomy System Trial (COAST) clinical trial. Taking place in the United States and Japan, the study is designed to assess the safety and efficacy, as well as economic outcomes, of CSI’s new micro crown Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions in patients suffering from Coronary Artery Disease (CAD). Arthur Lee, North Florida Regional Medical Center, Gainesville, Fla., performed the first procedure.

The micro crown is CSI’s second-generation system designed to facilitate stent delivery in subjects with CAD who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting. The micro crown OAS is designed to improve the tracking and piloting of the OAS driveshaft and the ability of the crown to reach the lesion while operating at low rotational speeds.

“During my first procedure using CSI’s new micro crown OAS, I modified a calcified lesion allowing stent delivery and expansion,” said Lee. “I’m encouraged by CSI's commitment to advancing and improving the technology by expeditiously releasing a second generation of technology in a space that has been stagnant for 25 years.”

Building on CSI’s ORBIT II study, the first study designed to enroll severely calcified lesions that are typically excluded from all major trials but commonly seen in the real world cases, COAST is a prospective, single-arm, multi-center, global, investigational study designed to evaluate the safety and efficacy of CSI’s new micro crown OAS in these difficult to treat lesions.

Up to 100 subjects may be enrolled at up to 15 U.S. sites and five sites in Japan. Minimum enrollment is 50 patients in the United States and 25 in Japan. Gregg Stone, director of cardiovascular research and education at the Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, and Dr. Shigeru Saito, director of cardiology and catheterization laboratories, Shonan Kamakura General Hospital, Kamakura, Japan, are the study’s principal co-investigators.

Stone said: “We’re excited for the potential of CSI’s new micro crown OAS device to provide additional treatment options for heavily calcified lesions seen in the ORBIT II study.”

“We’re eager to launch our first international coronary study which will support the approval of our next-generation system in the United States and Japan,” said David L. Martin, CSI president and chief executive officer. “COAST aligns with our ORBIT II data protocol and study details — giving CSI a further opportunity to build on the compelling results we delivered in ORBIT II. Additionally, it will highlight the potential benefits of our new micro crown and, we hope help secure commercial approval in Japan.”

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