Cardiovascular Systems has signed an exclusive distribution agreement with Medikit to sell its Diamondback 360 Coronary and Peripheral Orbital Atherectomy Systems (OAS) in Japan.
According to a press release, Medikit is one of the world’s leading manufacturers in vascular access and interventional medical devices, especially haemodialysis and other catheters used by hospitals for coronary and peripheral interventions. Medikit’s Japanese sales channel includes 120 sales representatives selling products to over 800 hospitals that perform percutaneous coronary interventions. To secure exclusive distribution rights, Medikit will make an upfront payment of US$10 million to CSI.
“The presence of severely calcified coronary lesions contributes to both poor patient outcomes and higher treatment costs,” said Nobufumi Kurita, president, Medikit. “We look forward to working with CSI to bring this important, novel technology, with compelling clinical and economic evidence, to the Japanese market.”
In June, CSI submitted a Shonin application to Japan’s Pharmaceuticals and Medical Devices Agency for approval of its Diamondback 360 Coronary OAS Micro Crown to treat severely calcified coronary arteries. The company anticipates commercialization beginning in calendar 2018. CSI will also pursue Shonin approval for its Diamondback 360 Peripheral Orbital Atherectomy System in the near future.
“We are excited to partner with Medikit, a highly respected distribution partner with a large sales force in Japan,” said Scott Ward, president and chief executive officer of CSI. “Japan represents the world’s second-largest market for coronary interventions, with a large patient population suffering from calcified artery disease. Physicians in Japan understand the challenges of treating calcified lesions and they are seeking novel tools, like orbital atherectomy, to improve clinical outcomes for their patients.”
CSI submitted its application for Shonin approval of the Coronary OAS Micro Crown following the completion of the COAST clinical study. COAST is a harmonisation-by-doing clinical study conducted in both the United States and Japan under the regulations of both governments. COAST is a single-arm, multicentre, global investigational device exemption (IDE) study to evaluate the safety and efficacy of CSI’s next-generation OAS in treating patients with severely calcified coronary lesions. The company completed COAST enrolment of 100 patients, including 74 patients at 12 sites in the United States and 26 patients at five sites in Japan, in July 2015. At the 2016 Cardiovascular Research Technologies Conference, data presented from the study showed a 30-day freedom from major adverse cardiac events rate of 85% and a successful stent delivery rate of 99%.