New Thoracic Stent Graft Blessed for Marketing
The Talent Thoracic Stent Graft manufactured by Medtronic was cleared for marketing by the Food and Drug Administration. The device is indicated to treat patients with aneurysms of the descending aorta, though only certain types of aneurysms can be treated with the Talent.
The Talent supports treatment with thoracic endovascular aortic repair (TEVAR). The stent is available in the broadest range of diameters currently available on the market, from 22 to 46 mm. The variability in size allows clinicians to choose the optimal stent size for each individual patient.
Availability of the new stent expands the number of patients eligible to undergo treatment with this approach. It is estimated that up to 25 percent more patients will be eligible for repair.
Data submitted to the FDA for device approval assessed almost 200 patients who had the Talent placed. These patients were treated at 38 different healthcare facilities across the country. Data collected was compared to matched patients who were treated with open surgical approaches.
Primary safety and efficacy goals were achieved in the study. Overall mortality was 16.1 percent and successful treatment of the thoracic aneurysm was 89.2 percent after a year of follow-up. This data indicates that treatment with the Talent stent had a lower rate of mortality and morbidity compared to open approaches. As well, the incidence of adverse events associated with the device was decreased.
The incidence of thoracic aneurysms among the elderly in the U.S. is 10 in 100,000. Many patients are not diagnosed with the condition because they remain asymptomatic. Rupture is most often fatal. For those patients who are diagnosed, more will be eligible for surgical repair with availability of the Talent.
June 10, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Cardiology