$CVRS Corindus Receives FDA Clearance for CorPath® GRX System in Peripheral Vascular Interventions
Business Wire Business Wire•February 20, 2018
WALTHAM, Mass.
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 use of its CorPath GRX System in peripheral vascular interventions. The CorPath System is the first and only FDA-cleared medical device to bring robotic precision to both percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI) procedures.
The advanced CorPath GRX System broadens the capabilities of the CorPath robotic technology platform from exclusively treating coronary artery disease (CAD) to include peripheral artery disease (PAD). It is estimated that 8.5 million people in the United States are living with PAD, a disease of blood vessels outside the heart that commonly affects arteries carrying blood to the lower extremities. In 2017, peripheral procedures were estimated to be a $3.4 billion market, and it is estimated that by 2020, one million PAD procedures will be performed annually in the U.S.1,2
"My colleagues and I have seen first-hand how CorPath GRX can overcome the challenges of manual PCI and I am excited to apply the capabilities of robotics to effectively treat PAD patients," said Alan Lumsden, M.D., Chief of the Department of Cardiovascular Surgery at Houston Methodist Hospital. "As a training site for future robotic interventionalists, I look forward to teaching these techniques to further enhance the quality of care for patients with both CAD and PAD."
"CorPath GRX enables me to provide transformational treatment options to my patients suffering from PAD," said Joseph Ricotta, M.D., Medical Director of Vascular Surgery and Endovascular Therapy, Tenet Healthcare, Professor of Surgery, Charles E Schmidt College of Medicine, FAU. "As a long-time adopter of robotics, I am passionate about the opportunity this technology presents to advance endovascular care while providing a safer work environment for healthcare providers."
Mark Toland, President and Chief Executive Officer of Corindus, stated, "The ability to treat patients with PAD using CorPath GRX is a significant step for Corindus as we expand the usage of our technology beyond PCI. The new indication aligns with our objective to provide more patients access to the benefits of precise robotic treatment while protecting healthcare professionals from harmful radiation during lengthy PVI procedures. We will continue to improve upon our technology platform with a keen focus on providing physicians the tools necessary to enhance patient care across the spectrum of interventional medicine."
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.
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