Medtronic completes PMA application for Talent stent

Medtronic has announced that it has filed the final module of its Pre-Market Approval (PMA) application with the US Food and Drug Administration (FDA) for the Talent Abdominal Stent Graft System.

The Talent stent graft is a device that treats dangerous bulges in the aorta artery in the heart.

Medtronic’s application follows a series of studies which show that the stent graft meets its primary safety endpoint of superiority in freedom from major adverse events at 30 days.

Also patients administered with the stent experienced lower rates of death, myocardial infarction, respiratory failure, paraplegia and blood loss compared with subjects treated with open surgery at 12 months.

Katie Szyman, vice-president and general manager of Endovascular Innovations, highlighted that a comprehensive clinical data set had been submitted as the final module as part of the PMA application.

“The Talent Abdominal System will expand treatment options for patients with abdominal aortic aneurysms and provide a strong complement to our market-leading Aneurx AAAdvantage Stent Graft,” she confirmed.

Medtronic has also filed a PMA for its Talent Thoracic Stent Graft that is currently under evaluation by the FDA.

Last month, Medtronic announced its financial results for the second quarter of the fiscal year 2008, reporting revenue of $3.124 billion (1.5 billion pounds).