Cardiovascular Systems (NSDQ:CSII) said today it won approval from Japan’s Ministry of Health, Labor and Welfare for its Diamondback 360 coronary orbital atherectomy system and its Classic Crown and ViperWire Advance coronary guidewire FlexTip.
The Classic Crown includes a a 1.25mm diamond-coated crown and uses centrifugal force and differential sanding to safely modify arterial calcium, the St. Paul, Minn.-based company said. The FlexTip is a new atherectomy guidewire with a nitinol core and shapeable stainless-steel tip for improved flexibility and kink-resistance, the company said.
“Using the new ViperWire Advance FlexTip combined with the GlideAssist feature on Classic Crown allowed me to easily track the OAS device through tortuous coronary vessels and effectively modify a calcified lesion facilitating stent deployment,” Cardiovascular Systems COAST trial national principal investigator Dr. Shigero Saito of Kamakura City, Japan’s Shonan Kamakura General Hospital said in a press release.
Cardiovascular Systems said that it won Japanese MHLW approval for the Diamondback 360 coronary OAS micro crown in March 2017, and reimbursement in February last year.
“We are excited to introduce the Classic Crown and FlexTip in Japan – the first market with an opportunity to use these two products together. Ten to 20% of the 280,000 Japanese patients who undergo percutaneous coronary interventions, or PCIs, each year have severely calcified coronary lesions. Multiple studies have shown that calcium is associated with poor PCI outcomes. Orbital atherectomy modifies calcific plaque to improve PCI results. Physicians in Japan may now consider our Classic Crown or Micro Crown to provide durable and cost-effective results for this large and underserved patient population,” prez & CEO Scott Ward said in a prepared statement.
Last month, Cardiovascular Systems touted that the first patients in the U.S. were treated with the OrbusNeich Teleport microcatheter.