CSI’s Next-Generation Diamondback 360 Coronary OAS Approved in Japan
January 2, 2019—Cardiovascular Systems, Inc. (CSI) announced that it has received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for the next generation of its Diamondback 360 coronary orbital atherectomy system (OAS), which includes the Classic Crown and ViperWire Advance coronary guidewire with FlexTip.
According to the company, the Classic Crown is a 1.25-mm diamond-coated crown that uses centrifugal force and differential sanding to safely modify arterial calcium. The FlexTip is an atherectomy guidewire with a nitinol core and shapeable stainless-steel tip that offers flexibility and kink resistance.
“Using the new ViperWire Advance FlexTip combined with the GlideAssist feature on the Classic Crown allowed me to easily track the OAS device through tortuous coronary vessels and effectively modify a calcified lesion, facilitating stent deployment,” said Shigeru Saito, who is with Shonan Kamakura General Hospital in Kamakura City, Japan, and is National Principal Investigator of the COAST trial.
CSI noted that it received Japanese MHLW approval for the Diamondback 360 coronary OAS Micro Crown in March 2017 and reimbursement in February 2018.