In Hopes To Expand Sales Overseas, Cardiovascular Systems Looks To Japan
Cardiovascular Systems Inc. is looking to break into its first international market: Japan.
On Thursday, the medical device company from New Brighton said it was seeking approval overseas for its Diamondback 360 Coronary Orbital Atherectomy System (OAS).
The heart device, which was approved in the U.S. in October 2013, sands down calcium and plaque build-up in the arteries so that a stent may be inserted. (A video describing the process can be found below.)
The Diamondback 360 device has been used in over 250,000 cases so far.
Coronary artery disease affects more than 16.3 million people in the U.S., according to the American Heart Association. Approximately 600,000 Americans die each year from the disease. In Japan, coronary artery disease stands as the second most common cause of death.
“The presence of severely calcified coronary lesions contributes to both poor patient outcomes and higher treatment costs around the world,” said Scott Ward, interim president and CEO of CSI.
A number of tests have been conducted on the effectiveness of CSI’s OAS technology. Recent data presented at the Cardiovascular Research Technologies Conference (CRT) found that its Diamondback 360 device created a 30-day freedom from major adverse cardiac events 85 percent of the time and allowed for a 99 percent successful stent delivery rate.
“The data we presented at CRT demonstrates the ability of our technology to treat this very challenging condition and patient population on a global scale,” Ward said.
To bring the technology to the Japanese market, CSI will need to accomplish two major tasks. The first is gaining approval through Japan’s Pharmaceuticals and Medical Devices Agency. An application, CSI said, has already been submitted.
Once approved, the med-tech company will then need to find a distribution partner in the country.
If all goes as planned, CSI expects commercialization to begin at the start of 2018.