WALTHAM, Mass.--(BUSINESS WIRE)--Corindus Vascular Robotics, Inc. (OTCQB:CVRS), a leading developer of precision vascular robotics, announced today that it has initiated a clinical trial of its CorPath System in peripheral vascular interventions. The study is currently enrolling patients at the Medical University of Graz in Graz, Austria, and is led by Prof. Dr. Marianne Brodmann, MD, a leading researcher within the university’s Division of Angiology, in combination with Prof. Dr. Hannes Deutschmann, of the Medical University of Graz Department of Radiology, and study chairman, Dr. Ehtisham Mahmud, director, Sulpizio Cardiovascular Center-Medicine, UC San Diego.
“I routinely use the CorPath System in complex PCI cases and it reduces my exposure to a significant amount of scatter radiation,” said Dr. Mahmud. “The value of precision and protection afforded to physicians performing PCI through robotic technology is considerable. As peripheral vascular procedures are lengthy and often complex, the ability to translate the effectiveness of robotic technology to peripheral interventions has tremendous potential to be of benefit to both patients and physicians.”
The trial is a prospective, single-arm, single-center study that will enroll up to 20 patients. Researchers participating in the study will assess the safety and effectiveness of the CorPath System in recanalizing lower extremity arterial blockages during peripheral angioplasty procedures.
“It was astonishing how easy it was to advance the guidewire and balloon catheter in a precise controlled manner in the superficial femoral artery,” said Dr. Brodmann. “The results of this trial can mean the extension of the CorPath System’s capabilities to a greater range of procedures to further transform care delivery in the cath lab.”
“The potential for interventionists to utilize the precision of robotics for peripheral vascular intervention may have significant implications for the care they provide to their patients, and their own health as well,” said David Handler, President and CEO, Corindus Vascular Robotics. “As concern about the risks of cumulative radiation exposure continues to grow for operators in the cath lab, an expansion of the CorPath System’s indications, if enabled by a successful clinical trial, would increase the number and variety of cases that can be performed under the protection of CorPath, which can be significantly beneficial to physician health.”
Developed by Corindus Vascular Robotics, the CorPath System is the first FDA-cleared medical device to bring robotic-assisted precision to coronary angioplasty procedures. The CorPath System is currently indicated in the US for PCI only. During the procedure, the interventional cardiologist sits in the radiation-shielded interventional cockpit and advances stents and guidewires with millimeter by millimeter precision.
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 FDA-cleared CorPath System is the first medical device that offers interventional cardiologists PCI procedure control from a radiation protective interventional cockpit. With the CorPath System, Corindus Vascular Robotics brings robotic precision to PCI procedures to help optimize clinical outcomes and minimize the costs associated with complications through 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' Prospectus, dated January 16, 2015, filed with the SEC 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.
