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 & CEO Dr. Jan Pietzsch said in prepared remarks.
Cardiovascular Systems said it won reimbursement approval in Japan this month, and that Medikit is acting as its exclusive distribution partner in the region.
“We are excited to bring orbital atherectomy technology to Japan. Ten to twenty percent of the 280,000 Japanese patients who undergo percutaneous coronary procedures each year have severely calcified coronary lesions. The introduction of Micro Crown gives physicians in Japan a cost-effective treatment option for this difficult-to-treat patient population,” prez & CEO Scott Ward said in a press release.