ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today announced that it has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for approval of its Diamondback 360® Coronary Orbital Atherectomy System (OAS) Micro Crown to treat severely calcified coronary arteries for the facilitation of stent placement.
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.
About Coronary Artery Disease (CAD)
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. The
plaque buildup causes the arteries to harden and narrow
(atherosclerosis), reducing blood flow. The risk of CAD increases if a
person has one or more of the following: high blood pressure, abnormal
cholesterol levels, diabetes, or family history of early heart disease.
According to the American Heart Association, 16.3 million people in the
United States have been diagnosed with CAD, the most common form of
heart disease. Heart disease claims more than 600,000 lives in the
United States each year and is the second most common cause of death in
Japan. According to estimates, significant arterial calcium is present
in nearly 40% of patients undergoing a percutaneous coronary
intervention (PCI). Significant calcium contributes to poor outcomes and
higher treatment costs in coronary interventions when traditional
therapies are used, including a significantly higher occurrence of death
and major adverse cardiac events (MACE).
About Cardiovascular Systems, Inc.
Cardiovascular Systems,
Inc., based in St. Paul, Minn., is a medical device company focused on
developing and commercializing innovative solutions for treating
vascular and coronary disease. The company’s Orbital Atherectomy Systems
treat calcified and fibrotic plaque in arterial vessels throughout the
leg and heart in a few minutes of treatment time, and address many of
the limitations associated with existing surgical, catheter and
pharmacological treatment alternatives. The U.S. FDA granted 510(k)
clearance for the use of the Orbital Atherectomy System in peripheral
arteries in August 2007. In October 2013, the company received FDA
approval for the use of the Orbital Atherectomy System in coronary
arteries. To date, over 249,000 of CSI’s devices have been sold to
leading institutions across the United States. The Coronary OAS Micro
Crown is limited by federal law to investigational use and is currently
not commercially available in the United States or Japan.
For more information, visit the company’s website at www.csi360.com.
Safe Harbor
Certain statements in this news release are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and are provided under the protection of
the safe harbor for forward-looking statements provided by that Act. For
example, statements in this press release regarding (i) expected
approval and commercialization of our OAS Micro Crown in Japan,
including the expected timing; (ii) finding a distribution partner in
Japan; and (iii) the COAST trial. These statements involve risks and
uncertainties that could cause results to differ materially from those
projected, including, but not limited to, regulatory developments in
Japan; PMDA and other clearances and approvals in Japan; approval of
products for reimbursement and the level of reimbursement in Japan; our
ability to find a distribution partner in Japan and to successfully
negotiate agreements with such partner; actual clinical trial and study
results; and other factors detailed from time to time in CSI’s SEC
reports, including its most recent annual report on Form 10-K and
subsequent quarterly reports on Form 10-Q. CSI encourages you to
consider all of these risks, uncertainties and other factors carefully
in evaluating the forward-looking statements contained in this release.
As a result of these matters, changes in facts, assumptions not being
realized or other circumstances, CSI's actual results may differ
materially from the expected results discussed in the forward-looking
statements contained in this release. The forward-looking statements
made in this release are made only as of the date of this release, and
CSI undertakes no obligation to update them to reflect subsequent events
or circumstances.