WALTHAM, Mass.--(BUSINESS WIRE)--Corindus Vascular Robotics, Inc. (NYSE American: CVRS), a leading developer of precision vascular robotics, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the first automated robotic movement designed for the CorPath GRX platform.
The proprietary software feature, named "Rotate on Retract" (RoR), is the first automated robotic movement in the technIQ Series for the CorPath GRX platform. It allows the operator to quickly navigate to a targeted lesion by automatically rotating the guidewire upon joystick retraction. Preclinical data presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in October 2017 demonstrated a significant reduction in wiring time among a highly-experienced group of physicians when comparing robotic wiring versus robotic wiring with RoR enabled.
Following the software's CE Mark approval in January 2018, interventional cardiologists Arif Al Nooryani, M.D. and Wael Aboushokka, M.D. of Al Qassimi Hospital in Sharjah, Dubai, UAE, performed the first percutaneous coronary interventional procedures (PCI) in the world using RoR. Today Nelson Bernardo, M.D., Medical Director of the Peripheral Vascular Laboratory at MedStar Heart Institute, will be performing a robotic-assisted peripheral intervention utilizing RoR, which will be broadcast live to the Cardiovascular Research Technologies (CRT) Meeting in Washington, D.C.
"This first-of-its-kind automation software has the potential to extend the clinical capabilities of CorPath GRX in more complex procedures," said J. Aaron Grantham, M.D., Chief Medical Officer of Corindus and practicing Interventional Cardiologist at Saint Luke’s Mid America Heart Institute. "Bringing consistency to interventional procedures through advanced wire movements has the opportunity to reduce procedure time and enhance patient outcomes."
Mark Toland, President and CEO of Corindus, stated, "FDA clearance of this new software feature marks the first step on our path to full autonomous navigation. Over the next several years, we will focus on automating the techniques of world-class physicians to make them available to every hospital with a vascular robotic program. We believe artificial intelligence through procedural automation will increase the value of robotics in the cath lab by reducing variability of treatment and procedure time, and improving the overall quality of patient care."
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 percutaneous coronary and percutaneous vascular 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. CorPath GRX is the second generation robotic-assisted PCI technology offering enhancements to the platform by adding important key upgrades that increase precision, improve workflow, and extend the capabilities and range of procedures that can be performed robotically. 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:
- robotic automation can potentially extend the clinical capabilities of CorPath GRX in more complex procedures;
- bringing consistency to interventional procedures through advanced wire movements may reduce procedure time and enhance patient outcomes;
- the FDA clearance of the new software marks the first step on Corindus' path to total autonomous navigation;
- Corindus will focus on automating the techniques of world-class physicians to make them available over the next several years to every hospital with a vascular robotic program; and
- artificial intelligence through procedural automation will increase the value of robotics in the cath lab by reducing variability of treatment and procedure time, and improving the overall quality of 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.