Problem:
Deep Vein Thrombosis (DVT) is a painful, debilitating and potentially life-threatening condition. Approximately 1.2 million cases are diagnosed annually in the US & EU, making it the 3rd largest cardiovascular disease behind heart attack and stroke. In simple terms, a blood clot forms inside a vein and prevents blood being transported back to the heart & lungs. If untreated, patients are at risk of some of this clot migrating to the lungs (known as Pulmonary Embolism or PE) which ha a high mortality rate. Several other complications, such as Post-Thrombotic Syndrome (PTS), causes long term pain and leg ulcers which can ultimately lead to limb amputation. DVT is differentiated from other clots in that it is present in large volumes and is adhered to the inner wall of the veins making clot removal very difficult. Effective, clot removal has been shown to reduce the incidences of PE and PTS severity, however current treatments are dependent on using aggressive drugs and are ineffective on wall adherent clot.
Why is it Important:
In addition to chronic long term health problems associated with Deep Vein Thrombosis and Post Thrombotic Syndrome, treatment costs for patients with DVT are high. The high cost of infusing clot-busting drugs (e.g. Catheter Directed Thrombolysis, CDT) is primarily due to the associated hospital stays – often up to 8 days, 1-2 of which are spent in the ICU. In addition to procedure day device costs, PMT devices often require the purchase of expensive capital equipment representing an unacceptable cost for many hospital budgets.
Overall Objective:
The challenge is to develop an effective device to treat all DVT patients for improved patient outcomes, reduced complications and reducing overall treatment costs. This will be achieved through generation of clinical data demonstrating the safety and efficacy profile of the Vetex Thrombectomy device. This clinical data will support regulatory approval of the device in the US and Europe and also support commercial launch through communication of device performance.
Conclusions of the Action:
The action was successfully completed through completion of a clinical trial and generation of clinical data demonstrating the safety and efficacy profile of the Vetex Thrombectomy device. The device manufacturing process has also been optimised for scaled production. The clinical data generated has supported the Company achieving FDA regulatory approval for the device in the US and CE approval in Europe, enabling market launch and commercialisation of the device.
