Technology | Peripheral Artery Disease (PAD) | February 20, 2018

FDA Clears Corindus CorPath GRX for Peripheral Vascular Interventions

Expanded indication extends robotic precision to broader patient base with vascular disease

FDA Clears Corindus CorPath GRX for Peripheral Vascular Interventions

February 20, 2018 — Corindus Vascular Robotics Inc. 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, according to the company, to bring robotic precision to both percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI) procedures.

The 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."

For more information: www.corindus.com

References

1. Millennium Research Group 2013 Peripheral Vascular Devices US 2013 Market Analysis RPUS 11PV14 p 98.

2. cdc.gov/PAD.

Related Content

TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
htisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...