news
Press release
 
March 29, 2016
FDA Clears CorPath Robotic System for Use in Peripheral Vascular Intervention

Expanded indication highlights continued development progress for vascular robotics

WALTHAM, MA - March 29, 2016Corindus Vascular Robotics, Inc. [NYSE MKT: CVRS], a leading developer of precision vascular robotics, announced today that the U.S. Food and Drug Administration has cleared the CorPath® System for use in peripheral vascular interventions. This is the third clearance for the CorPath System including the initial clearance for percutaneous coronary intervention (PCI) which was followed by a clearance for radial PCI in October 2015. This 510(k) clearance for peripheral intervention was based on results of a clinical trial known as the RAPID (Robotic-assisted Peripheral Intervention for Peripheral Artery Disease) Study conducted at Medical University Graz in Austria.

"For the past two years, I have been successfully treating my coronary patients with robotic precision while protecting my staff and me from the hazards of radiation exposure in the cath lab," said Ehtisham Mahmud, Chief of Cardiovascular Medicine, Director of Sulpizio Cardiovascular Center-Medicine, and Director of Interventional Cardiology at UC San Diego Health System. "The ability to expand robotic precision to treat my peripheral disease patients is an important addition; I am looking forward to continued work with Corindus to optimize robotic therapy for peripheral procedures."

Peripheral vascular procedures can be lengthy and lead to a very high level of radiation exposure for the physicians performing these procedures. The RAPID Study demonstrated that the CorPath System can successfully be used to treat peripheral disease, and previous studies have shown that using the CorPath System will reduce overall radiation exposure for physicians.

"Our first priority is to provide the best care to our patient community via robotic precision while protecting the physicians performing these important procedures," said Mark Toland, President and CEO, Corindus. "This FDA clearance demonstrates our commitment to the development of clinical data in our endeavor to expand the scope of robotic therapy."

The RAPID Study enrolled 20 patients with symptomatic disease with either presence of critical limb ischemia or lifestyle-limiting claudication requiring percutaneous transluminal angioplasty. The CorPath System demonstrated 100% device and clinical success in the study.

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
 
close the window

Please complete the form below in order to download the content.








right
close the window

Please complete the form below in order to download the content.







close the window

Please fill out this brief form to subscribe to our email newsletter.





close the window

Please complete the form below and a member of our Clinical team will contact you.






close the window

Please complete the form below in order to download the content.







close the window
Thank you for subscribing to our newsletter. You will now receive email updates from Corindus.