FDA Approves Robotic Angioplasty Tool
July 26, 2012

Robotic Angioplasty Tool Saves Surgical Teams From Radiation

John Neumann for redOrbit.com - Your Universe Online

The FDA has granted clearance for the first robotic-assisted percutaneous coronary intervention (PCI) system to be used by surgeons. The CorPath 200, from Massachusetts-based Corindus Vascular Robotics provides robotic assistance for heart surgeons that are performing angioplasty, reports Chris Kaiser for MedPage Today.

Angioplasty restores blood flow to a blocked coronary artery by inflating a balloon in the artery, and implanting a stent to keep the artery open.

Although the procedure is relatively common, it poses risks to the doctors who perform it. The patient is x-rayed throughout the procedure and the surgeon is exposed to the radiation.

Over time, this exposure can put the physician and surgical team at risk for brain tumors even though lead aprons are worn. During the procedure with the CorPath 200, the surgeon sits at a console away from the fluoroscopy system, thereby reducing operator radiation exposure.

The go-ahead by the FDA comes on the strength of the PRECISE trial, a prospective, single-arm, multicenter study presented at the recent annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).

Of the 162 procedures performed with the robotic technology in PRECISE, only two cases had to be converted to manual stent implantation, none of which was due to the robotic system, Giora Weisz, MD, of Columbia University Medical Center in New York City, reported at the time.

Weisz explained that the system that is better for doctors is also better for patients. “Overall, the system makes the doctor more relaxed. It´s better for patients would rather have a relaxed, fresh doctor than a tired, annoyed one,” he said.

“The precision of the procedure is also better, as is the visualization.  That means fewer mistakes and fewer chances that a patient will have to come back to surgery for a second stent. It just optimizes everything you do.”

During clinical trials, reports Alex Knapp for Forbes, the overall success rate of the procedure was 97.6 percent. There´s good news for doctors, too. Use of the CorPath 200 system reduced their radiation exposure by 95 percent.

“This is a huge step forward in interventional cardiology,” Dr. Weisz continued. “It´s standardizes performance and provides precise movements. It also brings additional benefits to both physician and patient.”

“What Corindus did was amazing engineering work that allows surgeons to perform flawlessly. I see this as the first big leap in robotics in terms of interventional cardiology. It´s the beginning of very bright future.”