WALTHAM, Mass.--(BUSINESS WIRE)--Corindus Vascular Robotics, Inc. [NYSE American: CVRS], a leading developer of precision vascular robotics, today announced first patient enrollment in the PRECISION GRX Registry, a post-market study to continue market surveillance of the Company's second generation CorPath GRX System.
The PRECISION GRX Registry will include up to 25 sites and enroll up to 1,000 patients receiving robotic-assisted percutaneous coronary intervention (PCI). The study will gather data to evaluate patient outcomes, potential economic benefits, procedural parameters and the expanding capabilities of robotics in PCI. Additional sub-studies will seek to evaluate the impact of robotics on left transradial access and robotic wiring times. Dr. Ehtisham Mahmud, Division Chief of UC San Diego Health, Cardiovascular Medicine and Medical Director, Sulpizio Cardiovascular Center, has been named as the Global Principal Investigator for the PRECISION GRX Study.
"We have shown that robotic-assisted PCI can be used with high clinical and technical success in multiple sites with multiple operators and the new Registry is designed to evaluate the impact of the expanding capabilities of robotics," said Ehtisham Mahmud, MD. "I look forward to spearheading the effort in evaluating this new technology and its value in current practice."
The procedure on the first patient in the trial was performed by Dr. Srini Potluri at The Heart Hospital Baylor Plano, one of two Baylor hospitals participating in the Registry. The hospital currently has two CorPath GRX Systems installed in its catheterization labs. Dr. Potluri stated, "I am excited to participate in the PRECISION GRX Registry to expand the depth of clinical research supporting robotic-assisted PCI. Our participation emphasizes our continuous commitment to advancing patient care in interventional medicine."
"Enrollment of the first patient in the PRECISION GRX Registry is a major milestone for the Company and we look forward to the participation of leading centers across the country," said Mark Toland, President and Chief Executive Officer of Corindus. "We strongly believe that the improvements to the CorPath platform with GRX will further validate the widespread benefits and adoption of robotic-assisted PCI."
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.
An example of such a statement is that:
- the PRECISION GRX Study will include up to 25 sites, enroll up to 1,000 patients receiving PCI, and will gather data to evaluate patient outcomes, potential economic benefits, procedural parameters and the expanding capabilities of robotics in PCI, with additional sub-studies seeking to evaluate the impact of robotics on left transradial access and robotic wiring times;
- the new Registry is designed to evaluate the impact of the expanding capabilities of robotics and the effort in evaluating this new technology and its value in current practice; and
- Corindus' belief that the improvements to the CorPath platform with GRX will further validate the widespread benefits and adoption of robotic-assisted PCI.
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.