Corindus has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) for use of the CorPath GRX system in peripheral vascular interventions. The system brings the added benefits of robotic precision and radiation protection to minimally invasive techniques.
The CorPath system is the first and only FDA-cleared medical device to bring robotic precision to both percutaneous coronary intervention and peripheral vascular intervention procedures, a company release states. The advanced CorPath GRX system broadens the capabilities of the CorPath robotic technology platform from exclusively treating coronary artery disease to include peripheral arterial disease, the release adds.
“My colleagues and I have seen first-hand how CorPath GRX can overcome the challenges of manual percutaneous coronary intervention and I am excited to apply the capabilities of robotics to effectively treat peripheral arterial disease patients,” said Alan Lumsden, chief of the Department of Cardiovascular Surgery at Houston Methodist Hospital, Houston, USA. “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 coronary artery disease and peripheral arterial disease.”
“CorPath GRX enables me to provide transformational treatment options to my patients suffering from peripheral arterial disease,” said Joseph Ricotta, medical director, Vascular Surgery and Endovascular Therapy, Tenet Healthcare, professor of Surgery, Charles E Schmidt College of Medicine, FAU, Boca Raton, USA. “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 CEO of Corindus, stated, “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 peripheral vascular intervention procedures.”