Rex Medical recently announced that it has received 510k clearance from the US Food and Drug Administration (FDA) for the Revolution Peripheral Atherectomy System.
Regulatory clearance was based on data provided by the REVEAL investigational device exemption (IDE) clinical trial. The results of this pivotal trial demonstrated the safety and effectiveness of the Revolution Peripheral Atherectomy System for lower extremity peripheral arterial revascularisation in 121 subjects with femoropopliteal/tibial occlusive disease. The trial met all prespecified primary and secondary safety and effectiveness endpoints.
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.
According to a press release, 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 and chronic total occlusions (CTOs). 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 prior to use.
Jeffrey G Carr, Tyler Cardiac and Endovascular Center, served as the study’s principal investigator and stated, “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 utilising percutaneous transluminal angioplasty (PTA), drug-coated balloons, and stenting. Continuous mechanical aspiration to reduce the potential for distal embolisation is a distinct advantage associated with this technology. Intraprocedural embolisation continues to be a key concern for many atherectomy procedures.”