Pending approval, Japan would become the first international market for any CSI product and would represent a significant milestone for the company. CSI expects commercialization beginning in calendar 2018 and is currently working to find a distribution partner in Japan.
The second generation device builds on the technology of the first generation coronary OAS, which has been approved in the United States since October 21, 2013.
The fundamental, novel mechanism of action remains unchanged; however, the second generation device incorporates a diamond-coated tip for immediate engagement in tight lesions.
Additionally, the increased mass of the sanding crown allows for lower rotational speeds while maintaining the same orbit potential as the first generation OAS. The unique orbital mechanism of action for both the first and second generation OAS is designed to allow continuous flow of blood during treatment, which is important for both acute and long-term success.
"The presence of severely calcified coronary lesions contributes to both poor patient outcomes and higher treatment costs around the world," said Scott Ward, Chairman and Interim President and Chief Executive Officer of CSI.
"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."
Application for approval was made following the completion of the company’s Harmonization-By-Doing clinical study, COAST, conducted in both the United States and Japan under the regulations of both governments.
COAST is a single-arm, multi-center, 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 for the facilitation of stent placement.
The company completed COAST enrollment 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 recent 2016 Cardiovascular Research Technologies Conference (CRT), data presented from the study showed a 30-day freedom from MACE (major adverse cardiac events) rate of 85% and a successful stent delivery rate of 99%.
Research has shown that an increased amount of calcium deposits leads to a higher incidence of MACE when compared to non-calcified lesions. Calcified lesions have been shown to respond poorly to balloon angioplasty and, therefore, are associated with a high frequency of restenosis, target lesion revascularization (TLR), vessel dissection during percutaneous coronary intervention (PCI), failure to deliver a stent, balloon ruptures and un-dilatable lesions.
Up to 50% of coronary stents deployed in calcified lesions have been found to have asymmetric stent expansion, potentially increasing the likelihood of stent thrombosis and/or restenosis. As the concentration of calcium increases, so do the odds of a vessel perforation during PCI.
CAD is a life-threatening condition and a leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart.
