Cardiovascular Systems, (CSI) (NASDAQ:CSII), today released 30-day results from its Coronary Orbital Atherectomy System Study (COAST) in a late-breaking presentation at the 2016 Cardiovascular Research Technologies (CRT) conference in Washington, D.C.
The COAST study is CSI’s prospective, single-arm, multi-center, global IDE trial to evaluate the safety and efficacy of the company’s next-generation Micro Crown orbital atherectomy technology in treating patients with severely calcified coronary lesions.
It follows the ORBIT II pivotal trial of the company’s Diamondback 360® Coronary OAS Classic Crown, which received PMA approval from the U.S. Food and Drug Administration (FDA) in 2013 as a primary treatment for severely calcified coronary arteries when facilitating stent delivery.
CSI completed COAST enrollment of 100 patients, including 74 patients at 12 sites in the United States and 26 patients at five sites in Japan, in July 2015.
Dr. Richard A. Shlofmitz of St. Francis Hospital in Roslyn, N.Y., presented the 30-day results including the primary endpoints of procedural success and the freedom from major adverse cardiac events (MACE), including target lesion revascularization (TLR) at 30 days after the procedure.
Additional authors on the abstract are: Dr. Shigeru Saito, Shonan Kamakura General Hospital, Kamakura, Japan; Dr. Samin K. Sharma, Mount Sinai Medical Center, N.Y.; and Dr. Gregg Stone, Columbia University Medical Center, N.Y.
"Adequate modification of severely calcified plaque is an important step to achieve successful stent delivery and expansion," said Dr. Shlofmitz. "The Diamondback 360° Coronary OAS Micro Crown is designed to engage tight lesions with distal sanding. The results from the COAST IDE Study resulted in 99 percent successful stent delivery and 85 percent freedom from 30-day MACE."
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 Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.