1-Year Study Outcomes for Vetex Medical’s ReVene Thrombectomy Catheter Meet Primary Endpoint

March 17, 2021—Vetex Medical Ltd. announced positive 1-year results from a European clinical study of the company’s ReVene thrombectomy catheter in patients with iliofemoral vein thrombus. ReVene uses dual-action technology designed to declot peripheral vessels through wall-to-wall contact in a single session, with or without the use of thrombolytics.

The findings demonstrated that treatment with the device significantly improved the patients’ symptoms and quality of life while reducing their leg swelling. The results were presented by the study’s Principal Investigator Professor Stephen A. Black, MD, at Venous 2021, the annual meeting of the American Venous Forum, held virtually March 17-20.

“In this study, we saw a very low rate of postthrombotic syndrome at 12 months, with all patients seeing improvements in symptoms and quality of life and no safety concerns,” commented Prof. Black in the company’s press release. “I found the ReVene device very effective at removing clot and very straightforward to use. These outcomes are really very exciting and show a great deal of promise in improving outcomes in the management of clot in the peripheral vasculature for the benefit of both patients and the health care system.” Prof. Black is Consultant Vascular Surgeon at Guy’s and St Thomas’ Hospital NHS Foundation Trust and Professor of Venous Surgery at Kings College Hospital in London, United Kingdom.

According to the company, the multicenter VETEX European clinical study of thrombus extraction with the ReVene device enrolled patients with acute iliofemoral deep vein thrombosis, the majority of whom had severe disease.

As outlined by Vetex Medical, the study outcomes included the following:

• The primary endpoint was met with 100% procedural success and achievement of grade II lysis in the target vessel, with no instances of procedure- or device-related adverse events or complications, including major bleeding.
• The median Villalta score decreased from 15 at baseline to 2 at 12 months (P < .001).
• The median Venous Clinical Severity Score decreased from 9 at baseline to 2 at 12 months, demonstrating a durable outcome out to 1 year. (P < .001).
• The median Venous Insufficiency Epidemiological and Economic Study quality-of-life score increased from 57 at baseline to 98 at 12 months. (P < .001)
• The median thrombectomy time (including imaging assessments) was 23 minutes and as short as 3 minutes.

On March 1, 2021, Vetex Medical announced that the ReVene thrombectomy catheter received FDA 510(k) clearance for the following indication: “The device is indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature.” The Ireland-based company advised that the device is expected to be commercially available in the United States later in 2021.