Vetex Medical Ltd. today announced positive one-year results from a European clinical study of patients with iliofemoral vein thrombus that demonstrated that the ReVene® Thrombectomy Catheter significantly improved their symptoms and quality of life, while reducing their leg swelling. Results were presented today at VENOUS 2021, the annual meeting of the American Venous Forum, by principal investigator Stephen A. Black, MD, Consultant Vascular Surgeon, Guy’s and St Thomas’ Hospital NHS Foundation Trust and Professor of Venous Surgery, Kings College Hospital, London.
ReVene uses dual-action technology designed to de-clot peripheral vessels through wall-to-wall contact in a single session with or without the use of thrombolytics.
“In this study, we saw a very low rate of Post-Thrombotic Syndrome at 12 months, with all patients seeing improvements in symptoms and quality of life, and no safety concerns,” said Prof. Black. “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 healthcare system.”
The multicenter, VETEX European study of the ReVene Thrombectomy Catheter enrolled patients with acute iliofemoral deep vein thrombosis (DVT), the majority of whom had severe disease. Study outcomes included:
- The primary endpoint was met – 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, a symptoms measure, decreased from 15 at baseline to 2 at 12 months. (P<0.001)
- The median VCSS Score, a symptoms measure, decreased from 9 at baseline to 2 at 12 months, demonstrating a durable outcome out to one year. (P<0.001)
- The median VEINES QoL score, a measure of quality of life, increased from 57 at baseline to 98 at 12 months. (P<0.001)
- The median thrombectomy time (including imaging assessments) was only 23 minutes, and as short as three minutes.
Study investigators also included Michael Lichtenberg, MD, Chief Physician, Arnsberg Vascular Centre and President of the German Angiology Society, and Professor Gerry O’Sullivan, Professor of Interventional Radiology, Galway University Hospital and Clinical Director at the Galway Clinic, Ireland.
ReVene removes clot with a unique dual-action approach: a dynamic cage separates clot from vessel walls through wall-to-wall contact, while the catheter simultaneously draws clot into the device, where it is macerated and transported out of the body. The device is purpose-built for the venous system and safeguards vessel walls and valves by self-adapting to vessel size and physiology. Clot is continuously extracted during the procedure, minimizing the number of device passes and creating procedural efficiencies. The single-use device does not require time- and space-consuming capital equipment.
“We are excited about the clinical results for ReVene. We expected that the innovative dual-action of the device would improve upon the effectiveness of other thrombectomy methods designed to be used without thrombolytic drugs, and we were pleased to see very low Post-Thrombotic Syndrome rates in patient follow-ups,” said Vetex Medical Ltd. CEO Mark Bruzzi. “We look forward to making ReVene available in the U.S. later this year.”