WALTHAM, Mass.--(BUSINESS WIRE)--Corindus Vascular Robotics, Inc. (NYSE MKT: CVRS), a leading developer of precision vascular robotics, announced today that the first commercial procedures have been performed using its CorPath GRX System following the company’s recent 510(k) clearance from the U.S. Food and Drug Administration (FDA). In early February, NewYork-Presbyterian, UC San Diego Health, and University of Virginia Health System used the CorPath GRX System to perform robotic-assisted PCI procedures. Corindus began limited installations of the CorPath GRX System in January 2017 with plans for a full commercial launch in late February.
Hospital programs provided positive feedback on their initial experience with the CorPath GRX System.
Manish Parikh, MD, Associate Director of the Cardiac Catheterization Laboratory at NewYork-Presbyterian, stated, "We are proud to be among the group of premier hospitals that performed the first cases in the world using the new CorPath GRX System. The enhancements provided by CorPath GRX represent a dramatic improvement in the capabilities in robotic PCI and have the potential to provide significant improvements in patient care."
Ehtisham Mahmud, MD, Division Chief of UC San Diego Health, Cardiovascular Medicine and Medical Director, Sulpizio Cardiovascular Center, stated, "I am impressed with the additional capabilities of the new GRX System. The redesigned bedside unit, intuitive control console, and especially guide catheter control further facilitate complex PCI procedures. It also enables me to train other interventionalists and fellows in state-of-the-art robotics."
Michael Ragosta, MD, Interventional Cardiologist, stated, "The CorPath GRX System provides me with complete robotic control during complex PCI procedures. Using CorPath GRX and its radiation-shielded cockpit has enabled me to expand the number of procedures I can perform."
CorPath GRX offers enhancements to the CorPath platform by adding important key upgrades that increase precision, improve workflow, and extend the capabilities and range of procedures that can be performed robotically. The unique Active Guide Management feature allows interventional cardiologists to control the guide catheter, which was not possible with the first generation technology. Physicians now have independent and simultaneous robotic control of guide catheters, guidewires, and balloon/stent catheters, with one-millimeter advancement, from the cockpit console. This precise positioning that allows physicians to adjust guide catheters during PCI procedures may expand the use of the CorPath GRX System to more complex cases. CorPath GRX also features a completely redesigned bedside unit featuring an extended reach arm and touchscreen display to streamline workflow.
"Completion of these initial CorPath GRX procedures marks an important step forward in vascular robotics," said Mark Toland, President and Chief Executive Officer of Corindus Vascular Robotics. "We are committed to continuing to develop and deliver innovative products to advance the field of cardiovascular robotics and support better patient outcomes."
About Corindus Vascular Robotics
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 interventional procedures. 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 include statements:
- that Corindus plans for the full commercial launch of CorPath GRX System beginning later this month;
- that the precise positioning that allows physicians to adjust guide catheters during PCI procedures may expand the use of the CorPath GRX System to more complex cases; and
- that the enhancements provided by CorPath GRX have the potential to provide significant improvements in patient care.
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.
(1) Mahmud E. et al. "CORA-PCI Study," University of California, San Diego Sulpizio Cardiovascular Center. Presented at SCAI 2016.
(2) Weisz G, et al. "Safety and Feasibility of Robotics Percutaneous Coronary Intervention," J. American College of Cardiol, 2013, Vol. 61, No. 15: 1596-1600.
(3) Smilowitz et al. "Robotic-Enhanced PCI Compared to the Traditional Manual Approach," J Invasive Cardiol, 2014;26)7):318-321.
(4) Campbell P.T., et al. "The Impact of Precise Robotic Lesion Length Measurement on Stent Length Selection: Ramification for Stent Savings." Poster Presentation CRT 2015.