Medtronic announced on 5 August 2010 the enrolment of the first patient in the Medtronic 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.
The study is being conducted under an investigational device exemption (IDE) in the United States.
Medtronic initiated its Dissection Trial in May 2010 and will enrol a total of 50 patients across 25 centres in the USA. Zvonimir Krajcer, 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.
“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,” said Krajcer. “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 received the CE Mark in 2005 and is available in more than 90 countries outside the United States. Indicated for the treatment of a variety of thoracic aortic lesions, the device has been used to treat more than 15,000 patients worldwide. Both the Valiant Thoracic Stent Graft and the Captivia Delivery System are investigational in the United States, where their use is limited to clinical trials approved by the FDA.