FDAnews Device Daily Bulletin

Cardiovascular Systems Signs Distribution Agreement with Medikit for Japan

Nov. 15, 2016

Cardiovascular Systems has signed a distribution agreement with Medikit to sell its Diamondback 360 Coronary and Peripheral Orbital Atherectomy Systems (OAS) in Japan.

Cardiac Systems has submitted its application for Shonin approval of the Coronary OAS Micro Crown following the completion of the Coast clinical study which evaluated the safety and efficacy of Cardiac Systems’ OAS in treating patients with severely calcified coronary lesions.

The company 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.

Data was presented from the study showed a 30-day freedom from major adverse cardiac events rate of 85 percent and a successful stent delivery rate of 99 percent. — Cynthia Jessup

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