FDA Clears Rex Medical’s Revolution Peripheral Atherectomy System


September 12, 2019—Rex Medical, LP announced that it has received FDA 510(k) clearance for the Revolution peripheral atherectomy system. The Revolution device is indicated for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease. European CE Mark approval is anticipated in Q4 2019, advised the company.

According to Rex Medical, the Revolution is an ergonomically designed low-profile rotational atherectomy system with continuous mechanical aspiration for below-the-knee and above-the-knee applications, including multiple plaque morphologies ranging from thrombus and soft plaque to severely calcified lesions and chronic total occlusions. This device is operated by a 72-watt power supply (similar in size to a laptop computer charger) and requires no capital equipment and minimal setup time before use.

The company stated that FDA regulatory clearance was based on data provided by the REVEAL investigational device exemption clinical trial. The results of this pivotal trial demonstrated the safety and effectiveness of the Revolution system for lower extremity peripheral arterial revascularization in 121 patients with femoropopliteal/tibial occlusive disease. The trial met all prespecified primary and secondary safety and effectiveness endpoints.

Jeffrey G. Carr, MD, from the Tyler Cardiac and Endovascular Center in Tyler, Texas, served as the REVEAL study’s Principal Investigator. In the company’s announcement, Dr. Carr commented, “Peripheral artery disease and critical limb ischemia are associated with significant patient quality of life and major health issues. 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.”


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