Medtronic has reported that the first patient has been treated with Valiant Thoracic Stent Graft with the Captivia Delivery System in RESCUE Clinical Study.
Medtronic RESCUE (Evaluation of the Clinical PeRformanceE of the Valiant Thoracic Stent Graft with the Captivia Delivery System for the EndovaSCUlar TrEatment of Blunt Thoracic Aortic Injuries) clinical trial will evaluate the safety and effectiveness of the Valiant Captivia system in the treatment of patients with blunt thoracic aortic injury.
Medtronic had initiated the RESCUE clinical trial in March 2010 and expects to enroll a total of 50 patients at up to 25 sites in the US. Dr Anthony Murphy, a vascular surgeon at the Suncoast Medical Clinic, and Dr Joshua Rovin, a cardiothoracic surgeon with Cardiac Surgical Associates, both in St Petersburg, Florida, collaborated on the first Valiant Captivia implant in RESCUE.
The Valiant Captivia system is indicated for the treatment of a variety of thoracic aortic lesions and has been used to treat more than 15,000 patients worldwide. Both the Valiant Thoracic Stent Graft and Captivia Delivery System are investigational in the US, where their use is limited to clinical trials approved by the FDA.
Dr Rovin said: “Many patients with BTAI never make it to the emergency room. Those who do typically arrive with tears of the aortic wall and internal bleeding that require surgery to repair. But for some patients, due to other circumstances of their injury, surgery is too risky to attempt.”
Dr Murphy said: “This trial will help to determine if Valiant Captivia is effective for patients with BTAI. If the technology works in demanding clinical situations such as total aortic transection, it may have positive implications for the treatment of other aortic injuries.”