Corindus Vascular Robotics (NYSE:CVRS) said today that it won FDA 510(k) clearance for its robotic-assisted CorPath system for peripheral interventions, a year after launching a clinical trial.
The clearance was based on the 20-patient Rapid trial, a prospective, single-arm, single-center study designed to look at the safety and effectiveness of the CorPath device in peripheral artery disease patients with lower-extremity blockages.
“For the past 2 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,” co-lead investigator Dr. Ehtisham Mahmud, of the UC San Diego Health System, said in prepared remarks. “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.”
“Our first priority is to provide the best care to our patient community via robotic precision while protecting the physicians performing these important procedures,” added new president & CEO Mark Toland. “This FDA clearance demonstrates our commitment to the development of clinical data in our endeavor to expand the scope of robotic therapy.”
Corindus won FDA clearance in July 2012 to use CorPath in coronary angioplasty procedures, and added a radial access clearance in October 2015.
In August 2015, Corindus said it signed a distribution agreement with Unfors RaySafe to offer RaySafe’s i2 radiation dose monitoring system with CorPath.
The partnership will allow cath lab physicians and staff to better monitor and protect themselves from excessive radiation exposure, Waltham, Mass.-based Corindus said.