GALWAY, Ireland--(BUSINESS WIRE)--Vetex Medical Ltd. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the ReVene® Thrombectomy Catheter. ReVene uses dual-action technology designed to de-clot peripheral vessels, such as in Deep Vein Thrombosis (DVT), through wall-to-wall contact in a single session without the use of thrombolytics. The device is expected to be commercially available in the U.S. later in the year.
“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 healthcare system,” said 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. “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.”
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.
Six-month outcomes from the VETEX clinical study of acute iliofemoral DVT patients, the majority of whom had severe disease with chronic clot noted during thrombectomy, 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 only 23 minutes, and as short as three minutes. In 89 percent of cases, no thrombolytics were used during the procedure to achieve these results. Data was presented at the 2021 Leipzig Interventional Course (LINC) by Professor Gerry O’Sullivan of Galway University Hospitals.
“Physicians tell us that they want greater predictability and reliability in DVT clot removal, and we intend to be at the forefront of enhancing patient outcomes in the treatment of DVT,” said Vetex Medical Ltd. CEO Mark Bruzzi. “We are taking innovation further than anyone that has come before by integrating our venous-specific technologies to enhance efficacy, safety and cost-effectiveness for the entire healthcare system.”
Current DVT Treatment
While anticoagulation remains the most widespread therapy for DVT, interventional treatment has demonstrated the potential for better outcomes in select patients. Currently available interventional DVT treatment options include the use of thrombolytic drugs to dissolve clot, with or without the use of a mechanical device, or purely mechanical devices that use fragmentation and/or aspiration to create a core through the center of the clot. Because thrombolytic agents thin the blood, they present a bleeding risk for many patients and can require prolonged hospital stays. Without effective treatment, up to 50 percent of patients with symptomatic DVT will develop Post-Thrombotic Syndrome (PTS) within two years, which causes chronic limb pain, swelling, heaviness, fatigue, and in extreme instances, limb ulceration.
About Vetex Medical Ltd.
Vetex Medical Ltd. is a privately held company headquartered in Galway, Ireland, focused on developing innovative, effective, and efficient solutions for removal of venous thromboembolism to improve clinical outcomes and quality of life for patients. The ReVene Thrombectomy Catheter is the company’s first innovation in a range of products specifically engineered for use in the treatment of venous disease. For more information, please visit www.vetexmedical.com.