ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon.
OrbusNeich’s 1.0mm Sapphire II PRO, the first and only 1.0mm coronary balloon available in the U.S., offers industry-leading entry and crossing profiles and is precision engineered for crossing and treating extremely tight and complex lesions.
In January, CSI announced it is the exclusive U.S. distributor of OrbusNeich balloon products. OrbusNeich is a globally recognized corporation with established balloon technologies in both percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).
“As physicians, we have continued to advance techniques and expand access to interventional cardiology procedures. As a result, the patients we are treating today have become increasingly complex, with more challenging lesions and anatomy, and with more difficult clinical indications,” according to David E. Kandzari, M.D., Director of Interventional Cardiology and Chief Scientific Officer, Piedmont Heart Institute, Atlanta, GA, and principal investigator for the Sapphire II PRO U.S. Clinical Study. “With its exceptionally low profile and deliverability, the Sapphire II PRO is an important new tool to enable us to better treat the patients we serve.”
Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “Offering the Sapphire II PRO 1.0mm coronary balloon—the smallest, FDA-cleared coronary balloon on the market—is critical for physicians treating highly complex coronary lesions. As the market leader in coronary atherectomy, the 1.0mm balloon complements our orbital atherectomy system as we continue providing advanced solutions for treating the complex and high-risk indicated patient.”
At launch, CSI will offer both the 1.0-4.0mm Sapphire II PRO and the 2.0-4.0mm Sapphire® NC Plus non-compliant coronary balloons on a limited basis. The company anticipates that OrbusNeich’s full balloon product portfolio will become available in the U.S. throughout 2018 and 2019.
OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products include the world's first dual therapy stents, the COMBO Plus and COMBO Dual Therapy Stents, together with stents and balloons marketed under the names of Azule®, Scoreflex®, Sapphire® II, Sapphire® II PRO and Sapphire® II NC, as well as products to treat peripheral artery disease: the Jade® and Scoreflex® PTA balloons. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries. For more information, visit www.OrbusNeich.com.
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 the first 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 Coronary Orbital Atherectomy System. To date, over 356,000 of CSI’s devices have been sold to leading institutions across the United States. For more information, visit the company’s website at www.csi360.com.
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 the benefits of the 1.0mm balloon and the commercial launch of OrbusNeich’s balloon portfolio in the U.S., including the anticipated timing thereof, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, agreements with third parties to sell their products; the experience of physicians regarding the effectiveness and reliability of products sold by CSI; the reluctance of physicians, hospitals and other organizations to accept new products; the impact of competitive products and pricing; 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.
US Indications for Use
The Sapphire® II PRO Coronary Dilatation Catheter (1.0-1.25mm configurations) is indicated for:
- Balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purposes of improving myocardial perfusion
The Sapphire® II PRO Coronary Dilatation Catheter (1.5-4.0mm configurations) is indicated for:
- Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
- Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction