CSI Seeks Approval in Japan for Diamondback 360 Coronary OAS Micro Crown

July 8, 2016—Cardiovascular Systems, Inc. (CSI) announced this week that it has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency for approval of its Diamondback 360 coronary orbital atherectomy system (OAS) micro crown to treat severely calcified coronary arteries for the facilitation of stent placement.

CSI expects commercialization of the device beginning in 2018 and is currently working to find a distribution partner in Japan. Pending approval, Japan would become the first international market for any CSI product.

According to the company, the second-generation device builds on the technology of the first-generation coronary OAS, which was approved in the United States in October 2013. The original mechanism of action remains unchanged, but the second-generation device incorporates a diamond-coated tip for immediate engagement in tight lesions. Additionally, the increased mass of the sanding crown allows for lower rotational speeds while maintaining the same orbit potential as the first-generation OAS. Both devices’ orbital mechanism of action allows a continuous flow of blood during treatment.

The application for approval was made following the completion of the company’s COAST study, conducted in both the United States and Japan under the regulations of both governments and the countries’ Harmonization-By-Doing initiative. 

COAST is a single-arm, multicenter, global investigational device exemption study to evaluate the safety and efficacy of CSI’s next-generation OAS in treating patients with severely calcified coronary lesions for the facilitation of stent placement. In July 2015, CSI announced 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 February, the company announced the presentation of the 30-day data from COAST at CRT 2016, the Cardiovascular Research Technologies conference in Washington, DC. The study showed a 30-day freedom from major adverse cardiac events rate of 85% and a successful stent delivery rate of 99%.