Rex Medical, L.P., a medical device design and development company, today announced the successful completion of enrollment in the Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization (REVEAL) IDE clinical trial.
The REVEAL trial is a single arm, prospective study to evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease. 121 patients were successfully enrolled in 17 U.S. sites. The company will file a regulatory submission to the U.S. Food and Drug Administration (FDA) in May, 2019 and is currently under CE review.
Peripheral artery disease (PAD) and its most severe form, critical limb ischemia (CLI), affect over 10 million people in the U.S. and occur when an artery becomes blocked or narrowed due to plaque or calcium deposits which in turn reduces blood flow to the lower extremities. Left untreated, this can result in pain, ulceration, gangrene and amputation. Successful revascularization and blood flow restoration is essential in the treatment and quality of life improvement for this patient population.
The Rex Medical Revolution™ Peripheral Atherectomy System is an innovative and ergonomically designed low profile rotational atherectomy system (140,000 RPM) with continuous mechanical aspiration for below-the-knee (BTK) and above-the-knee (ATK) applications including multiple plaque morphologies ranging from thrombus and soft plaque to severely calcified lesions. This device is operated by a 72 watt power supply similar in size to a laptop computer charger and requires no capital equipment along with minimal setup time prior to use.
Jeffrey G. Carr, MD, FACC, FSCAI, Cardiovascular Associates of East Texas, served as the study’s Principal Investigator and stated, “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. In addition, the efficient aspiration feature reduces the potential for intraprocedural embolization and associated complications. No capital equipment along with fast and user-friendly set up is a discernible advantage to those physicians performing procedures in office interventional suites (OIS), outpatient surgery centers (ASCs) and hospital settings.”
Commenting on the recent regulatory achievement, Rex Medical President, Lindsay L. Carter, “The successful completion of this trial is an important milestone for our company. We would like to thank all site investigators and clinical teams for their support and hard work throughout this study and look forward to working with both U.S. and OUS regulatory agencies to bring this differentiated technology to the interventional community and patient population undergoing treatment for peripheral arterial disease.”