Periodic Reporting for period 2 - VETEX (Deep Vein Thrombosis; A Paradigm Change in Treatment through Drug-Free Clot Removal)
Reporting period: 2020-05-01 to 2021-07-31
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.
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.
To ensure the device is appropriate for use in the market Vetex have evaluated the marketing and clinical needs and documented the associated device claims that are required to be met in order to address the needs. A market review was also conducted to better understand the market size and trends for venous thrombectomy and informed Vetex's sales and marketing strategy having regulatory approval of the device in EU and US markets. Vetex Medical have implemented a Regulatory Strategy achieving approvals in both the EU & US. The Strategy considered all aspects of medical device development as outlined in the numerous standards applicable to the development of a Class II medical device. As part of the development of the Quality Management System required for gaining Regulatory Approvals, Vetex Medical have developed and maintain Standard Operating Procedures to guide all company employees on methodologies to be deployed ensuring compliance to regulatory standards. As a supplier of a medical device, Vetex have secured certificartion to ISO 13485 standards following audit by the Notified body, DQS.
Test Protocols have been developed to meet regulations to ensure all testing (electrical testing, age testing, simulated use, etc.) are meeting FDA & CE requirements. All testing has been carried out per methods established in international guidance and regulatory standards where possible to gain regulatory approvals in the EU & US.
The manufacturing process has been optimised and the validation process has been reviewed by the notified body. The device was evaluated for safety and efficacy in a clinical study in Europe where the safety and performance profile was demonstrated. The clinical study results have been presented in conference presentations and a manuscript has been prepared and submitted for publication in a leading journal. Regulatory approvals were achieved in both the US (under FDA's 510(k) pathway) and in Europe through the CE Mark, enabling commercialisation of the device.