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Press release
 
October 6, 2015
FDA Clears CorPath® System for Robotic-assisted Radial Access PCI Procedures

CorPath System Provides Important Protection from Occupational Hazards in Growing Radial PCI Market

WALTHAM, MA - October 6, 2015Corindus Vascular Robotics, Inc. [NYSE MKT: CVRS], a leading developer of precision vascular robotics, announced today that the U.S. Food and Drug Administration has given 510(k) clearance for its robotic-assisted CorPath System to be used during percutaneous coronary interventions (PCIs) performed via radial access. The 510(k) clearance was based on results of a clinical trial conducted at Spectrum Health, Grand Rapids, Mich., and St. Joseph's Hospital Health Center, Syracuse, N.Y., with an enrollment of 30 patients that demonstrated 100 percent device and clinical success.

The radial approach for PCI has been steadily growing in popularity and is now utilized in approximately 40 percent of PCIs in the U.S. During radial PCI, the physician threads a catheter to the patient's heart from the radial artery at the patient's wrist rather than into the femoral artery at the patient's upper thigh. The radial approach delivers similar procedural success as femoral PCI procedures but with fewer access site or vascular complications. Studies also demonstrate that radial PCI procedures can significantly reduce hospital stays and associated costs as patients are able to return home shortly after the procedure. While radiation exposure to patients during PCI procedures is similar regardless of access site, the REVERE trial1 demonstrated that interventional cardiologists are exposed to significantly higher levels of radiation while performing left-radial as opposed to femoral access procedures.

"Radial access is a critical technique to improve patient experience and reduce post procedural complications. It will doubtless become the predominant approach in the U.S. as it has abroad," said Ryan Madder, MD, an interventional cardiologist at the Frederik Meijer Heart & Vascular Institute of Spectrum Health. "I routinely use the CorPath System in radial PCI and have found it to be useful in reducing my radiation exposure in these radial cases. Minimizing operator radiation in these cases is particularly important considering that some studies have shown radial access to be associated with increased radiation exposure."

"The FDA's clearance for radial access PCI with the CorPath System is a significant step in the adoption of robotic PCI. We are looking forward to further expand the use of the CorPath System enabled by this new clearance. The CorPath System's ability to protect cath lab personnel during these cases is more important than ever with the increasing prevalence of radial and complex PCI in today's cath lab," said David Handler, President and CEO, Corindus.

To test drive complex robotic-assisted PCI at the upcoming TCT 2015 conference, visit Corindus Vascular Robotics' booth #1525, or register here. For more information about the CorPath System, visit www.corindus.com.

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 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 event

Examples of such statements include statements:

  • that the level of precision that can be attained using the CorPath GRX technology, combined with the potential for remote capabilities in the future, will both expand and improve how patients are treated;
  • that Corindus has entered a transformational period with a focus on expanding its reach to partner with hospitals to build robotic programs globally;
  • that the successful completion of these procedures at Fu Wai Hospital is the first step in Corindus' growth strategy within China; and that
  • the precise positioning enhancements to the CorPath platform that allows physicians to adjust guide catheters during PCI procedures may expand the use of the CorPath GRX System to more complex cases.

Media Contacts:

Corindus Vascular Robotics, Inc.

Kate Stanton
(508) 653-3335 ext. 200
kate.stanton@corindus.com

Investor Contact:

Lynn Pieper Lewis
(415) 937-5402
ir@corindus.com
 
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