The Rex Medical Revolution rotational atherectomy system incorporates continuous aspiration and has a dual indication for atherectomy and thrombectomy.
November 7, 2019 — The REVEAL FDA investigational device exemption (IDE) trial confirmed a favorable safety and effectiveness profile through six months for the Rex Medical Revolution rotational atherectomy system. The results were presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting by presenter Jeffrey G. Carr, M.D., FACC, FSCAI University of Texas Health.
The Rex Medical Revolution rotational atherectomy system incorporates continuous aspiration and has a dual indication for atherectomy and thrombectomy. The device is intended for atherectomy of the peripheral vasculature in patients with obstructive atherosclerotic disease both above and below the knee. No capital equipment is required. The spheroid-shaped burr rotates at 140,000 rpm to ablate plaque, which is aspirated into the catheter.
The primary objective of the REVEAL trial was to evaluate the safety and effectiveness of the Revolution peripheral atherectomy system in patients with symptomatic infrainguinal lower extremity arterial obstructive disease. One 121 patients were enrolled at 17 U.S. sites. Patients with Rutherford category 2-5 disease and lesions with ≥70% stenosis were eligible. The primary safety endpoint was a composite of 30-day major adverse events, including all-cause mortality, clinically driven target lesion revascularization, amputation, vessel perforation, and embolization. The primary effectiveness endpoint was technical success, defined by core laboratory–assessed ≤50% diameter stenosis after treatment prior to adjunctive therapy.
The 30-day primary safety and effectiveness endpoints were met, with freedom from 30-day major adverse events in 110 of 113 (97.3%) intention-to-treat patients at 30 days (both distal embolizations were clinical events committee adjudicated as nondevice-related) and technical success in 111 of 123 (90.2%) target lesions. Excluding lesions that were treated with a burr not appropriately sized for the vessel diameter from the data set in which the post-atherectomy stenosis was > 50%, the technical success rate was 95.7% (111 of 116 patients) (nonimputed). The procedural success rate was 93.7% (119 of 127 patients). The six-month outcomes were also favorable.
The Revolution received FDA 510(k) clearance in September 2019.