On December 8 2004, Bolton Medical announced that it had received authorization from the US Food and Drug Administration (FDA) to commence a Phase I clinical trial of its Relay TAA stent graft. The Phase I study will evaluate the preliminary safety and performance of the Relay TAA stent graft. The study will encompass 30 patients at five investigational sites. The focus of the clinical trial will be the endovascular treatment of various forms of thoracic aortic aneurysms. This clinical feasibility trial will pave the way for an expanded Phase II trial.
The Relay TAA stent graft was designed from inception to accommodate the specific challenges of the thoracic aortic arch. These challenges relate to the three dimensional tortuosity found in the aortic isthmus and the anatomical and pathological changes that occur in the arch. The Relay is delivered endovascularly to the target site using the Transport delivery system. The Transport delivery system is designed to be able to navigate through the tortuous small femoral and iliac entry sites, but still be flexible enough to accommodate the severe angles associated with the thoracic arch.
"The FDA approval to commence the Phase I, clinical trial, is a major milestone for the company" said Simon Fuger, Bolton Medical's CEO and General Manager.
"The differing anatomical conditions found in the thoracic aorta and the diverse nature of each patient's disease state can place unique stresses on made materials".
