REVEAL Data Presented for Rex Medical’s Revolution Rotational Atherectomy System

 

November 5, 2019—VIVA Physicians announced that findings from the REVEAL study confirm a favorable safety and effectiveness profile at 30 days and through 6 months for the Revolution peripheral atherectomy system (Rex Medical, LP). Jeff Carr, MD, presented the findings in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.

According to the VIVA announcement, the Revolution 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.

In September 2019, Rex Medical announced that it had received FDA 510(k) clearance for the Revolution peripheral atherectomy system and that European CE Mark approval is anticipated in Q4 2019. The Revolution system, which required no capital equipment, features a spheroid-shaped burr that rotates at 140,000 rpm to ablate plaque, which is aspirated into the catheter.

As summarized by VIVA, 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.

Investigators enrolled 121 patients at 17 sites in the United States. Patients with Rutherford class 2 to 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 as core laboratory–assessed ≤ 50% diameter stenosis after treatment before adjunctive therapy.

Dr. Carr reported that 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 adjudicated by a clinical events committee 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 postatherectomy 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 6-month outcomes were also favorable, concluded Dr. Carr.

 

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