Cardiovascular Systems launches Diamondback 360 in Japan, touts 1st patient treated

Cardiovascular Systems (NSDQ:CSII) said yesterday it launched its Diamondback 360 coronary OAS micro crown device in Japan, touting that the first patient had been treated with the system. The device won approval in Japan as a treatment for de novo severely calcified lesions to allow access to arteries for percutaneous coronary interventions based on data from the Coast trial of the device. “Patients with severely calcified coronary lesions are some of the most difficult to treat, leading to unfavorable clinical and economic outcomes. The commercialization of the Micro Crown in Japan provides physicians with a new technology to treat this unmet medical need,” Coast trial principal investigator Dr. Shigeru Saito, who treated the first patient, said in a prepared statement. The St. Paul, Minn.-based company’s Coast trial was conducted across both the U.S. and Japan and evaluated the safety and efficacy of the device in treating patients with severely calcified coronary lesions. Data from the 100-patient study indicated a 99% rate of successful stent delivery and an 85% rate of freedom from major adverse cardiac events at 30 days. “In a post hoc economic subanalysis, orbital atherectomy was associated with a reduction in one-year reintervention costs when compared to historical rotational atherectomy data. This is due to the reduced need for repeat revascularization, lower cardiac mortality and fewer devices used per procedure,” Wing Tech prez &a...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Vascular Cardiovascular Systems Inc. Source Type: news