Medtronic has enrolled first patient in its Dissection Trial, which is evaluating the clinical performance of the Valiant Thoracic Stent Graft with the Captivia Delivery System, for the treatment of acute, complicated Type B aortic dissection, a serious cardiovascular condition associated with high morbidity and mortality, under an investigational device exemption (IDE) in the US.
Medtronic initiated the Dissection Trial in May 2010 and will enroll a total of 50 patients across 25 centers across the US. Dr Zvonimir Krajcer, MD, co-director of the Peripheral Vascular Disease Service at St Luke’s Episcopal Hospital in Houston, treated the trial’s first patient with Type B aortic dissection.
Dr Krajcer said: “Patients with acute, complicated Type B aortic dissection require immediate treatment, and the Valiant Captivia system holds great promise as a minimally invasive treatment for this challenging patient group. This trial will help to determine if the Valiant Captivia system is a safe and effective alternative to invasive surgery for these patients.”
The Valiant Thoracic Stent Graft is said to be received the CE mark in 2005 and is available in more than 90 countries outside the US. Both the Valiant Thoracic Stent Graft and the Captivia Delivery System are investigational in the US, where their use is limited to clinical trials approved by the FDA.