FDA Clears Vetex ReVene Thrombectomy Catheter

ReVene thrombectomy device

Vetex Medical Ltd. tells us that the U.S. FDA 510(k) has cleared its the ReVene® Thrombectomy Catheter. Vetex expects to make the device commercially available in the U.S. later in the year.

Background

Anticoagulation remains the most widespread therapy for Deep Vein thrombosis (DVT). However, interventional treatment has demonstrated the potential for better outcomes in select patients. Current options include firstly the use of thrombolytic drugs to dissolve clot, with or without the use of a mechanical device. Secondly, purely mechanical devices that fragment and/or aspirate to create a core through the center of the clot.

Thrombolytic agents thin the blood. This means 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. This in turn causes chronic limb pain, swelling, heaviness, fatigue, and in extreme instances, limb ulceration.

About Vetex and its ReVene system

Vetex Medical Ltd. focuses on developing solutions for removal of venous thromboembolism. This means the company is directly targeting improved clinical outcomes and quality of life for patients.

The ReVene Thrombectomy Catheter is Vetex’s first innovation in a range of products specifically engineered for use in the treatment of venous disease. ReVene uses dual-action technology designed to de-clot peripheral vessels, such as in Deep Vein Thrombosis (DVT). It does this in a single session without the use of thrombolytics.

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. From here the device macerates the clot for removal 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. The system continuously extracts clot throughout the procedure. This minimizes the number of device passes and creates procedural efficiencies. Importantly 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 showed significant improvements in symptoms, leg swelling and quality of life. There were 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 procedure was completed with no thrombolytics.

Professor Gerry O’Sullivan of Galway University Hospitals presented the full findings at the 2021 Leipzig Interventional Course (LINC).

Clinician comments

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 stated; “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.

“The device has achieved promising clinical results using minimal passes to remove thrombus, even in difficult-to-treat patients. Furthermore there is no need for thrombolytics in most patients, only an overnight hospital stay, 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.”

Company comments

Vetex Medical Ltd. CEO Mark Bruzzi said; “Physicians tell us that they want greater predictability and reliability in DVT clot removal. We intend to be at the forefront of enhancing patient outcomes in the treatment of DVT”

“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.”

At MedLatest, thrombectomy and associated devices are repeat visitors to out pages. Take a look at past posts on the subject here.

Source: Vetex Medical Ltd.

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