Rex Medical said last week that it received FDA 510(k) clearance for its Revolution peripheral atherectomy system.
The Conshohocken, Pa.-based company’s Revolution device is indicated for atherectomy of the peripheral vasculature and is designed to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.
In the 121-person Reveal IDE pivotal clinical trial, the Revolution system demonstrated safety and effectiveness, meeting all primary and secondary endpoints, according to a news release.
Rex Medical expects to receive CE Mark approval in the fourth quarter of fiscal 2019, president Lindsay Carter said in the release.
“We are pleased to provide a new, innovative and differentiated peripheral atherectomy system designed for effective treatment of the global patient population impacted by symptomatic infrainguinal lower extremity arterial occlusive disease,” Carter said in prepared remarks.
“[Peripheral artery disease] and [critical limb ischemia] are associated with significant patient quality of life and major health issues,” added principal investigator Dr. Jeffrey Carr of the Tyler, Texas, Cardiac & Endovascular Center. “The recent clearance of Revolution technology will assist the interventional community in the effective reduction of calcification and vessel preparation in multiple lesion morphologies prior to adjunctive therapy utilizing percutaneous transluminal angioplasty, drug-coated balloons, and stenting. Continuous mechanical aspiration to reduce the potential for distal embolization is a distinct advantage associated with this technology. Intraprocedural embolization continues to be a key concern for many atherectomy procedures.”