Drug-free, mechanical removal of blood clots The formation of blood clots in veins deep inside the body is a potentially life-threatening condition affecting millions of individuals every year. Treatment is set to change with a promising, novel device that removes endovascular clots with a minimally invasive procedure. Industrial Technologies Health © Surmodics Physiologically, blood clots can be lifesaving, as they stop the bleeding from a cut or injury. The trigger, usually from a damaged blood vessel, activates platelets, clotting factors, red blood cells and proteins like fibrin that form the gel-like or semisolid structures known as clots. However, when the blood doesn’t flow properly, it can result in clotting problems such as deep vein thrombosis (DVT). Conventionally, DVT and other blood clotting problems are treated with anticoagulation drugs that prohibit propagation of the clots, rather than by removing them. A clot-removing mechanism that limits drug use and operative trauma Endovascular clot removal is an alternative approach that uses catheters or balloons for the mechanical removal of blood clots, providing immediate symptom relief. These methods can be used alone or in combination with thrombolytic drugs. The EU-funded VETEX project has engineered an innovative device that enables the removal of blood clots attached to the vein wall in a single session – and without the need for thrombolytics. “Our device employs a minimally invasive catheter designed to remove clots from occluded [blocked] veins in a safe, efficient and predictable manner,” explains project coordinator Con O’Brien of Vetex Medical. The device is inserted through a small incision at the back of the knee and is guided to the occluded area of the vein. A small umbrella-like wire mesh basket expands at the end of the device inside the vein, disrupting and capturing the clot. Through a rotary mechanism, the clot is transported through the device outside of the body. The basket then collapses, and the device is removed from the patient, leaving behind a fully functional vein with restored blood flow. Clinical validation, positive feedback and advantages The device was tested in 19 patients who were monitored for 1 year post treatment. Study results were highly encouraging, demonstrating the successful evaluation endpoint, i.e. removal of clots from all patients in a speedy process. VETEX received extremely positive feedback from both physicians and the patients, who were discharged within 24 hours of undergoing the procedure. “One of the main advantages of the VETEX procedure is that it can be completed without the need for thrombolytic drugs, avoiding the need for prolonged patient monitoring in the ICU, and the associated cost,” emphasises O’Brien. In addition, the device is suitable for patients not able to take thrombolytic drugs. And importantly, the innovative VETEX technology enables the mechanical removal of venous clots adherent to the vessel walls, which are typically difficult to remove, even with thrombolytic drugs. Left untreated, blood clots in DVT patients can cause pulmonary embolism, which has a 50 % mortality rate. Moreover, DVT can lead to post thrombotic syndrome: this is responsible for limb swelling, ulceration, and in extreme cases, limb amputation. The VETEX device has the potential to effectively treat DVT and improve the clinical outcomes and quality of life of patients. VETEX has obtained regulatory approval in Europe, and FDA clearance in the United States; the next step is to take the device to the market. Surmodics, a company with expertise in new clinical products, will take over product manufacture and commercialisation, hoping to make it available in 2022. Keywords VETEX, blood clot, deep vein thrombosis, medical device, thrombolytic drug, venous clot, clotting, DVT
