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 given 510(k) clearance for its robotic-assisted CorPath System to be used during percutaneous coronary interventions (PCIs) performed via radial access. The 510(k) clearance was based on results of a clinical trial conducted at Spectrum Health, Grand Rapids, Mich., and St. Joseph's Hospital Health Center, Syracuse, N.Y., with an enrollment of 30 patients that demonstrated 100 percent device and clinical success.
The radial approach for PCI has been steadily growing in popularity and is now utilized in approximately 40 percent of PCIs in the U.S. During radial PCI, the physician threads a catheter to the patient's heart from the radial artery at the patient's wrist rather than into the femoral artery at the patient's upper thigh. The radial approach delivers similar procedural success as femoral PCI procedures but with fewer access site or vascular complications. Studies also demonstrate that radial PCI procedures can significantly reduce hospital stays and associated costs as patients are able to return home shortly after the procedure. While radiation exposure to patients during PCI procedures is similar regardless of access site, the REVERE trial1 demonstrated that interventional cardiologists are exposed to significantly higher levels of radiation while performing left-radial as opposed to femoral access procedures.
"Radial access is a critical technique to improve patient experience and reduce post procedural complications. It will doubtless become the predominant approach in the U.S. as it has abroad," said Ryan Madder, MD, an interventional cardiologist at the Frederik Meijer Heart & Vascular Institute of Spectrum Health. "I routinely use the CorPath System in radial PCI and have found it to be useful in reducing my radiation exposure in these radial cases. Minimizing operator radiation in these cases is particularly important considering that some studies have shown radial access to be associated with increased radiation exposure."
"The FDA's clearance for radial access PCI with the CorPath System is a significant step in the adoption of robotic PCI. We are looking forward to further expand the use of the CorPath System enabled by this new clearance. The CorPath System's ability to protect cath lab personnel during these cases is more important than ever with the increasing prevalence of radial and complex PCI in today's cath lab," said David Handler, President and CEO, Corindus.
To test drive complex robotic-assisted PCI at the upcoming TCT 2015 conference, visit Corindus Vascular Robotics' booth #1525, or register here. For more information about the CorPath System, visit www.corindus.com.
About Corindus Vascular Robotics, Inc.
Corindus Vascular Robotics, Inc. is a global technology leader in robotic-assisted percutaneous coronary interventions (PCIs). The company's CorPath System is the first FDA-cleared medical device to bring robotic-assisted precision to PCI 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 PCI procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement with manual PCI 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 30, 2015 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 and 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.
1 Pancholy SB, Joshi P, Shah S, et al. Randomized evaluation of vascular entry site and radiation exposure: the REVERE trial. J Am Coll Cardiol Intv. 2015; Epub ahead of print.