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Press release
 
July 25, 2012
FDA Clears First Robotic-Assisted System for Coronary Artery Disease Stent Procedures

Corindus Vascular Robotics wins 510(k) clearance for CorPath® 200 System; Robotic-assisted percutaneous coronary interventions (PCI) enhances control and protects physicians from radiation

NATICK, Mass. – July 25, 2012 – Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced FDA 510(k) clearance has been granted for the CorPath 200 System to be used in performing percutaneous coronary interventions (PCI). The technology is now approved in the United States to assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in patients with coronary artery disease (CAD).

"We are pleased to have received clearance from the FDA for the world's first system designed for robotic-assisted PCI procedures," said David M. Handler, President and CEO of Corindus Vascular Robotics. "This is an important milestone for interventional cardiology as we take the next step in transforming the way these procedures are performed in the future. The CorPath System offers hospitals the opportunity to bring robotic-assisted technology benefits to their coronary patients and their physicians."

"The FDA clearance of the CorPath System will truly change the way I am able to practice. As interventional cardiologists, we perform our procedures using X-ray guidance and are cognizant that throughout our careers, we will be exposed to a high amount of radiation. In the past, we have relied on heavy lead aprons to protect us from radiation, but the physical stress of wearing these aprons can lead to back pain, fatigue and orthopedic injuries," said Joseph P. Carrozza, Jr. M.D., Chief of Cardiovascular Medicine at St. Elizabeth's Medical Center in Boston. "Robot-assisted PCI procedures allow us to provide our patients with the highest quality of care working in an ergonomic position with robotic-assisted stent and balloon placements to restore blood flow."

Recent data published in Catheterization and Cardiovascular Intervention journal demonstrated an interventional cardiologist's daily exposure to radiation and the physical stresses inherent in the cath lab can lead to occupational health risks, including orthopedic problems, cataracts, and cancer. The CorPath PRECISE Trial—a prospective, single-arm, multi-center, study, which served as the basis for the submission of a pre-market clearance (510(k)) application to the FDA—demonstrated that robotically-assisted PCI is safe and feasible for patients. PCI was successfully completed without having to convert to manual PCI in 98.8 percent of patients and without device-related complications. The overall procedure success rate was 97.6 percent. Additionally, the trial found that robotic-assisted PCI can make the procedure safer for the interventional cardiologist by reducing the radiation exposure by 95 percent when performing the procedure with the CorPath 200 System.

"Gaining significant experience with the CorPath 200 System, I was impressed with its performance and the precise control of the interventional devices, including manipulating the guidewire and stent and being able to move the devices precisely in increments as small as one millimeter," said Giora Weisz, M.D., Director of Clinical Research at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and Associate Professor of Medicine at Columbia University College of Physicians and Surgeons, New York. "Working with this robotic technology is very intuitive and the PRECISE trial demonstrated its applicability in today's cath lab environment. I strongly believe robotic-assisted PCI will enhance the way we are conducting PCI, and we are looking forward to adapting it in our everyday practice."

The CorPath 200 System is the first and only robotic-assisted procedure to allow for controlled placement of coronary guidewires and stent/balloon catheters from an optimized interventional cockpit. The lead-lined cockpit protects the interventional cardiologist from harmful radiation exposure and the seated position in front of monitors may provide enhanced view of the angiography screen while reducing fatigue and minimizing head, neck and back strain.

"There has been a tremendous amount of interest in the CorPath 200 System, and we are excited to bring to market a solution that has the potential to transform the standard of care for PCI procedures," said Handler. "Corindus is ready to help our customers successfully implement the complete CorPath-assisted procedure program into their institutions."

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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