FDA Clears Vetex Medical’s ReVene Thrombectomy Catheter

March 1, 2021—Vetex Medical Ltd. announced FDA 510(k) clearance for the ReVene thrombectomy catheter. The Ireland-based company advised that the device is expected to be commercially available in the United States later in 2021.

ReVene uses dual-action technology designed to de-clot peripheral vessels, including deep vein thrombosis (DVT), in a single session without the use of thrombolytics.

According to the company, the device was evaluated in the VETEX clinical study of acute iliofemoral DVT patients, the majority of whom had severe disease with chronic clot noted during thrombectomy. Six-month outcomes showed significant improvements in symptoms, leg swelling, and quality of life, with no device-related adverse events or major bleeding reported. The median thrombectomy time was 23 minutes, with some procedures as short as 3 minutes. In 89% of cases, no thrombolytics were used during the procedure to achieve these results.

Professor Gerry O’Sullivan, MD, of Galway University Hospitals in Galway, Ireland, presented the data at LINC 2021, the Leipzig Interventional Course held virtually on January 25-29.

ReVene’s 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 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 capital equipment, noted the company.

“With ReVene, there is the exciting possibility that we may not only make thrombectomy a better procedure for the patient themselves, but also for the health care system,” commented Stephen A. Black, MD, in the company’s announcement. “The device has achieved promising clinical results using minimal passes to remove thrombus, even in difficult-to-treat patients, no need for thrombolytics in most patients, only an overnight hospital stay, and with ease of set-up and insertion. This technology offers the potential to increase procedural efficiency while also improving the cost dynamics of thrombus removal in the clinic.” Dr. Black, who served as principal investigator of the VETEX study, is Consultant Vascular Surgeon, Guy’s and St Thomas’ Hospital NHS Foundation Trust and Professor of Venous Surgery, Kings College Hospital, London, United Kingdom.