FDA Clears CorPath Robotic System for Use in Peripheral Vascular Intervention
Expanded indication highlights continued development progress for vascular robotics
WALTHAM, Mass.–(BUSINESS WIRE)–
Corindus Vascular Robotics, Inc. [NYSE MKT: CVRS], a leading developer of precision vascular robotics, announced today that the U.S. Food and Drug Administration has cleared the CorPath®System for use in peripheral vascular interventions. This is the third clearance for the CorPath System including the initial clearance for percutaneous coronary intervention (PCI) which was followed by a clearance for radial PCI in October 2015. This 510(k) clearance for peripheral intervention was based on results of a clinical trial known as the RAPID (Robotic-assisted Peripheral Intervention for Peripheral Artery Disease) Study conducted at Medical University Graz in Austria.
“For the past two years, I have been successfully treating my coronary patients with robotic precision while protecting my staff and me from the hazards of radiation exposure in the cath lab,” said Ehtisham Mahmud, Chief of Cardiovascular Medicine, Director of Sulpizio Cardiovascular Center-Medicine, and Director of Interventional Cardiology at UC San Diego Health System. “The ability to expand robotic precision to treat my peripheral disease patients is an important addition; I am looking forward to continued work with Corindus to optimize robotic therapy for peripheral procedures.”
Peripheral vascular procedures can be lengthy and lead to a very high level of radiation exposure for the physicians performing these procedures. The RAPID Study demonstrated that the CorPath System can successfully be used to treat peripheral disease, and previous studies have shown that using the CorPath System will reduce overall radiation exposure for physicians.
“Our first priority is to provide the best care to our patient community via robotic precision while protecting the physicians performing these important procedures,” said Mark Toland, President and CEO, Corindus. “This FDA clearance demonstrates our commitment to the development of clinical data in our endeavor to expand the scope of robotic therapy.”
The RAPID Study enrolled 20 patients with symptomatic disease with either presence of critical limb ischemia or lifestyle-limiting claudication requiring percutaneous transluminal angioplasty. The CorPath System demonstrated 100% device and clinical success in the study.
About Corindus Vascular Robotics, Inc.
Corindus Vascular Robotics, Inc. is a global technology leader in robotic-assisted vascular interventions. The company’s CorPath System is the first FDA-cleared medical device to bring robotic-assisted precision to radial coronary and peripheral procedures. During the procedure, the interventional cardiologist sits at a radiation-shielded workstation to advance stents and guidewires with millimeter-by-millimeter precision. The workstation allows the physician greater control and the freedom from wearing heavy lead protective equipment that causes musculoskeletal injuries. With the CorPath System, Corindus Vascular Robotics brings robotic precision to radial and complex interventional procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement with manual procedures. Corindus stands behind its product with its unique $1,000 hospital credit “One Stent Program.”
For additional information, visit www.corindus.com, and follow @CorindusInc.
Statements made in this release that are not statements of historical or current facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Corindus to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward looking statements. In addition to statements that explicitly describe such risks and uncertainties, readers are urged to consider statements in the conditional or future tenses or that includes terms such as “believes,” “belief,” “expects,” “estimates,” “intends,” “anticipates” or “plans” to be uncertain and forward-looking. Forward-looking statements may include comments as to Corindus’ beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside Corindus’ control. Examples of such statements include statements regarding the potential benefits of our CorPath System and robotic-assisted PCI for hospitals, patients and physicians. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: the rate of adoption of our CorPath System and the rate of use of our cassettes; risks associated with market acceptance, including pricing and reimbursement; our ability to enforce our intellectual property rights; our need for additional funds to support our operations; our ability to manage expenses and cash flow; factors relating to engineering, regulatory, manufacturing, sales and customer service challenges; potential safety and regulatory issues that could slow or suspend our sales; and the effect of credit, financial and economic conditions on capital spending by our potential customers. More information on potential factors that could affect Corindus’ financial results is included from time to time in the “Forward Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Corindus’ periodic and current filings with the SEC, as well as those discussed under the “Risk Factors” and “Forward Looking Statements” section of Corindus’ Annual Report on Form 10-K filed with the SEC on March 11, 2016 and available on Corindus’ website at http://www.corindus.com/about-corindus/investor-relations. Forward looking statements speak only as of the date they are made. Corindus undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date.