FDA Approves Pivotal Trial of Corindus CorPath 200

January 26, 2011—Corindus, Inc. (Natick, MA) announced that it has been granted conditional investigational device exemption approval from the US Food and Drug Administration (FDA) to evaluate the safety and effectiveness of its CorPath 200 system in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary intervention procedures.

The approval allows Corindus to begin its CorPath PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention Study) pivotal trial. PRECISE is a prospective, single-arm, multicenter study, which will initially enroll 154 patients in the United States. The results of this study will be the basis for a premarket 510(k) clearance application to the FDA. Patient enrollment is planned to begin in early 2011. In March 2010, the company completed its first-in-human clinical trial with the CorPath 200 system, which met its safety and efficacy endpoints.

The clinical endpoint of PRECISE is the ability to treat patients without the incidence of major adverse cardiovascular events. The trial will also be closely monitoring the radiation exposure to the interventional cardiologist while using the CorPath technology compared to the radiation exposure if the operator was performing the procedure at the table.

According to the company, the CorPath 200 system allows for controlled robotic-assisted placement of coronary guidewires and stent/balloon catheters from a lead-lined interventional cockpit.

“The CorPath system allows interventional cardiologists to operate in a comfortable environment, completely focused on the patient's physiology,” commented Joseph P. Carrozza, Jr, MD, a coprincipal investigator of PRECISE. “The ergonomically optimized cockpit enhances visualization while minimizing fatigue, radiation exposure, and other occupational hazards such as back strain.”