Enrollment Completed in Rex Medical’s REVEAL Peripheral Atherectomy IDE Trial
March 19, 2019—Rex Medical announced the completion of patient enrollment in the REVEAL investigational device exemption trial of the company’s Revolution peripheral atherectomy system in treating infrainguinal lower extremity peripheral arterial occlusive disease. The single-arm, prospective REVEAL study enrolled 121 patients in 17 United States sites to evaluate the system's safety and effectiveness.
The company describes the Revolution system as a low-profile rotational atherectomy platform with continuous mechanical aspiration intended for below-the-knee and above-the-knee applications, including plaque morphologies ranging from thrombus and soft plaque to severely calcified lesions.
“In our experience, the Revolution technology demonstrated effective vessel preparation in a diverse set of lesions both above and below the knee prior to adjunctive therapy," said Principal Investigator Jeffrey G. Carr, MD, of Cardiovascular Associates of East Texas, in the company's announcement. "In addition, the efficient aspiration feature reduces the potential for intraprocedural embolization and associated complications. No capital equipment along with fast and user-friendly setup is a discernible advantage to those physicians performing procedures in office interventional suites, outpatient surgery centers, and hospital settings.”
The system is currently under CE Mark review, and the company will file a regulatory submission to the FDA this May.