Rex Medical has completed the patient enrollment for the Revolution Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization (REVEAL) IDE clinical trial in the US.
Rex Medical stated that the trial is a single arm, prospective study to assess the safety and efficacy of the Revolution Peripheral Atherectomy System in treating infrainguinal lower extremity peripheral arterial occlusive disease.
The company enrolled 121 patients across 17 sites in the country. It will file a regulatory submission with the US Food and Drug Administration (FDA) in May this year and is presently under CE review.
Peripheral artery disease (PAD) and its most severe form, critical limb ischemia (CLI) are believed to affect more than 10 million people in the US. It occurs when an artery is either blocked or narrowed due to plaque or calcium accumulation and this can in turn reduce 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 treating and in improving the quality of life for patients.
Rex Medical says that its Revolution Peripheral Atherectomy System is an ergonomically designed low profile rotational atherectomy system (with 140,000 RPM) and with continuous mechanical aspiration for below-the-knee (BTK) and above-the-knee (ATK) applications including multiple plaque morphologies that range from thrombus and soft plaque to severely calcified lesions.
The device runs on a 72-Watt power supply similar in size to a laptop computer charger and needs no capital equipment, coupled with minimal setup time prior to use.
Rex Medical president Lindsay Carter said: “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 US and OUS regulatory agencies to bring this differentiated technology to the interventional community and patient population undergoing treatment for peripheral arterial disease.”
Based in Conshohocken, Pennsylvania, Rex Medical develops minimally invasive medical devices targeted towards cardiovascular, venous access, endosurgery and oncology markets.