Cardiovascular Systems Locks Down Distribution Partner For Japan Expansion

Cardiovascular Systems Locks Down Distribution Partner For Japan Expansion

The company’s flagship Diamondback 360 coronary device is expected to receive Shonin approval, which, if it does, will mark Cardiovascular Systems’ first step into an international market.

Cardiovascular Systems Inc. said it is on the brink of breaking into Japan, the company’s first international market, following successful efforts to lock down an overseas distributer.
All that remains for the New Brighton-based company is to receive Shonin approval (similar to FDA or Europe’s CE Mark approval) from Japan’s Pharmaceuticals and Medical Devices Agency for its Diamondback 360 Coronary and Peripheral Orbital Atherectomy Systems device.
Cardiovascular Systems’ Diamondback 360 device, which was approved in the U.S. in October 2013, is used to sand down calcium and plaque build-up in a heart’s arteries. The device is commonly used among patients with coronary artery disease and can ease the process of stent insertion during surgery. More than 250,000 cases have used the Diamondback 360 device to date.
If Cardiovascular Systems receives approval for the sale of its flagship device in Japan, it will likely provide a fruitful return for the company.
“Japan represents the world’s second-largest market for coronary interventions, with a large patient population suffering from calcified artery disease,” Scott Ward, CEO of Cardiovascular Systems, said in a statement. “We’re excited to partner with Medkit, a highly respected distribution partner with a large sales force in Japan.”
Medkit Co. specializes in the manufacture of coronary heart disease treatments and other medical devices, which is bolstered by a 120-person sales force. The Tokyo-based company said it sells medical products to over 800 hospitals and it will pay $10 million upfront to secure exclusive distribution rights of the Diamondback 360 device.
“We look forward to working with [Cardiovascular Systems] to bring this important, novel technology, with compelling clinical and economic evidence, to the Japanese market,” Medkit president Nobufumi Kurita said in a statement.
Both companies are anticipating an early 2018 start of commercialization efforts in Japan, which aligns with Cardiovascular Systems’ projection from July when it first announced its overseas expansion plan.