Cardiovascular Systems (NSDQ:CSII) said yesterday it is seeking Japanese approval for its Diamond back 360 coronary orbital atherectomy system micro crown designed to treat calcified coronary arteries to prep for stent placement.
The company said it submitted an application to Japan’s Pharmaceuticals and Medical Device Agency, and that if approved, it would be the 1st international market for Cardiovascular Systems’ devices.
“The presence of severely calcified coronary lesions contributes to both poor patient outcomes and higher treatment costs around the world. 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. We look forward to working with PMDA to bring this important, novel alternative technology, with compelling clinical evidence, to the Japanese market,” CEO Scott Ward said in a press release.
The application was submitted folowing the company’s Coast study, conducted across bot the U.S. and Japan, which evaluated the safety and efficacy of the device in treating patients with severely calcified coronary lesions. Data from the 100-patient study indicated a 99% rate of successful stent delivery and an 85% rate of freedom from major adverse cardiac events at 30 days.
Cardiovascular Systems said it expects to launch the device in Japan in 2018 and that it is currently looking for a distribution partner in the region.
Late last month, Cardiovascular Systems said it agreed to pay $8 million and sign a corporate integrity agreement to settle a False Claims Act lawsuit based on allegations from a former sales rep that the company ran kickbacks and an off-label marketing scheme to boost sales of its orbital atherectomy devices.
The settlement, 1st announced in March, calls for the St. Paul, Minn.-based company to pay $3 million up front and the remaining $5 million in 11 quarterly installments beginning in January 2017. The company will pay a 1.8% annual interest rate on the unpaid portion of the settlement, CSI said.
