WALTHAM, Mass.--(BUSINESS WIRE)--Corindus Vascular Robotics, Inc. [NYSE MKT: CVRS] announced today the latest post-market findings from the PRECISION Registry at the 2017 Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions. "Efficacy and Safety Outcomes of Radial-vs Femoral-Access Robotic Percutaneous Coronary Intervention: Final Results of the Multicenter PRECISION Registry” was presented on behalf of the PRECISION investigators by Ehtisham Mahmud, M.D., FSCAI of UC San Diego School of Medicine, on Friday, May 12, during the Late Breaking Clinical Trials Session. Findings show a high success rate of both radial and femoral access robotic-assisted percutaneous coronary interventions (PCI).
"The selection of this study as a Late Breaking Clinical Trial at SCAI 2017 is a testament to the significance robotics will have in invasive cardiology," stated Dr. Mahmud. "My early experience with the CorPath 200 System demonstrated feasibility, safety and procedural effectiveness of robotic PCI to be comparable to the manual approach, even in complex and radial access PCI. I am excited to lead the PRECISION GRX Registry to further demonstrate the applicability and value of CorPath GRX in complex and radial cases."
The PRECISION Study, a multicenter post-market registry for the evaluation of the effectiveness of the CorPath® 200 System, aimed to collect data on the routine use of the CorPath 200 System in PCIs. Giora Weisz, M.D., Associate Professor of Medicine at Columbia University Medical Center and at the Hebrew University, was the Principal Investigator for the PRECISION Registry. Results showed that 754 patients with an aggregate of 949 lesions were treated with robotic PCI using transradial access in 452 (59.9%) and transfemoral access in 298 (39.5%). Technical (88.6% TRA vs 82.4% TFA; p=0.0224) and clinical success rates (98.9% TRA vs 94.9% TFA; p=0.0019) for both groups were high.
Corindus is now launching the PRECISION GRX Study, a post-market registry to continue market surveillance of its second generation CorPath GRX System. Dr. Mahmud has been named as the Principal Investigator for the PRECISION GRX Study. The CorPath GRX System offers improvements in procedural control, enhanced workflow and radiation protection for physicians, patients and staff.
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 precision to percutaneous coronary interventions. During the procedure, the interventional cardiologist sits at a radiation-shielded workstation to advance guide catheters, 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 interventional procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement during 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.
Forward Looking Statements
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 are that:
- having this study selected as a Late Breaking Clinical Trial at SCAI 2017 is a testament to the significance robotics will have in invasive cardiology and
- the PRECISION GRX Registry will further demonstrate the applicability and value of the CorPath GRX in complex and radial cases.
Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled "Risk Factors" in the company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, including, but not limited to the following: 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. 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. More information is available on Corindus' website at http://www.corindus.com.