WALTHAM, Mass.--(BUSINESS WIRE)--Corindus Vascular Robotics, Inc. (NYSE MKT:CVRS), a leading developer of precision vascular robotics, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CorPath GRX, the second generation of its CorPath Vascular Robotic System. Corindus expects to commence commercialization of CorPath GRX in the first quarter of 2017.
“CorPath GRX is a critical advancement in our core technology and a meaningful step toward realizing our vision of fundamentally changing how PCI procedures are performed,” said Mark Toland, President and CEO of Corindus. "GRX will enable us to build more robust and sustainable cardiovascular robotic programs with our hospital partners as we remain focused on providing the highest level of care to patients while protecting the health and wellness of the cath lab staff. We are excited to debut the GRX at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference later this week where we will be holding clinician demonstrations."
CorPath GRX significantly builds upon the CorPath platform, adding a significant number of key upgrades that increase precision, improve workflow, and extend the capabilities and range of procedures that can be performed robotically. These features include Active Guide Management which enables control of the guide catheter along with robotic control of the guidewire and balloon or stent catheter, with one-millimeter advancement, from the control console. This precise positioning will enable physicians to adjust guide catheter position during PCI procedures, and may expand use of CorPath to more complex cases. CorPath GRX also features a completely redesigned Bedside Unit featuring an Extended Reach Arm and a touchscreen display to streamline workflow.
"The new features of the next generation CorPath System, particularly the addition of active guide catheter management, will allow physicians to increase the complexity of procedures performed robotically,” said J. Aaron Grantham, M.D., Chief Medical Officer of Corindus. “This is a tremendous advancement in the technology platform that will greatly extend the clinical capability of the system."
Corindus' CorPath System is the first and only FDA-cleared medical device to bring robotic precision to Percutaneous Coronary Interventions (PCI) and protects medical professionals from radiation exposure occurring in hospital cath labs.
CorPath GRX will be on display for the first time at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference where Corindus will sponsor a breakfast symposium entitled "Robotic Therapy – Current Applications & Future Vision" on Monday, October 31 at 7:00 a.m. Register here to visit Corindus at Booth #1322 for an opportunity to use CorPath GRX with an advanced simulator.
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 with 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.
* Clinical trials conducted using the CorPath 200 System
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 regarding:
- the expectation that Corindus will commence commercialization of CorPath GRX in the first quarter of 2017,
- that CorPath GRX is a critical advancement in Corindus' core technology that fulfills the Company's vision to fundamentally change how PCI procedures are performed, and
- that the new features of CorPath GRX will enable physicians to extend the volume and complexity of procedures performed robotically.
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.
