Vetex Medical has announced positive one-year outcomes from a European clinical study of the ReVene thrombectomy catheter. In patients with iliofemoral vein thrombus, the device was found to significantly improve symptoms and quality of life, while reducing leg swelling. Results were presented at VENOUS2021 (17–20 March, virtual), the annual meeting of the American Venous Forum, by principal investigator Stephen A Black (Guy’s and St Thomas’ Hospital NHS Foundation Trust and Kings College Hospital, London, UK).
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 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 multicentre, 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 decreased from 15 at baseline to two at 12 months (p<0.001)
- The median Venous Clinical Severity Score (VCSS) decreased from nine at baseline to two at 12 months, demonstrating a durable outcome out to one year (p<0.001)
- The median VEINES quality of life (QoL) score 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 (Arnsberg Vascular Centre, Arnsberg, Germany) and Gerry O’Sullivan (Galway University Hospital and the Galway Clinic, Galway, 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, minimising the number of device passes and creating procedural efficiencies. The single-use device does not require time- and space-consuming capital equipment.