News | October 30, 2014

Cardiovascular Systems Enrolls First Seven Patients in Japan for Coast Study

Study to assess safety and efficacy of new coronary micro crown to secure regulatory approval in United States and Japan

October 30, 2014 — Cardiovascular Systems Inc. announced that the first seven patients in Japan have been enrolled in its Coronary Orbital Atherectomy System Trial (COAST) study. 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). Shigeru Saito, M.D., director of cardiology and catheterization laboratories, Shonan Kamakura General Hospital, Kamakura, Japan, performed the procedures on Oct. 27.

The 1.25-mm micro crown is CSI’s second-generation system designed to facilitate stent delivery in patients with severely calcified lesions 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 lower rotational speeds.

“We’re excited to be in CSI’s pivotal COAST study,” said Saito. “Today, I used the company’s new micro crown OAS to successfully modify calcified coronary lesions in seven patients. Prepping the vessels with CSI’s technology enabled stent delivery and expansion in these challenging patient cases.”

Building on CSI’s ORBIT II study—the first study designed to enroll patients with severely calcified lesions who are typically excluded from all major trials but commonly seen in the real world—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 treating these difficult lesions.

Up to 100 subjects may be enrolled at up to 15 U.S. sites and five sites in Japan. Enrollment in the United States began in June 2014. Gregg Stone, M.D., director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at Columbia University Medical Center, New York, and Saito are the study’s principal co-investigators.

For more information: www.csi360.com

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