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Medtronic thoracic stent graft sees positive 12-month results

Medtronic : 08 June, 2007  (New Product)
Positive 12-month results have been presented by Dr Ronald M Fairman, principal investigator for the VALOR clinical study evaluating the Talent Thoracic Stent Graft System.
The results were presented at the annual meeting of the Society for Vascular Surgery in Baltimore, USA.

Sponsored by Medtronic, VALOR is a prospective, multi-centre study of 195 test group patients with thoracic aortic aneurysms who were considered candidates for open surgical repair.

The primary endpoint is 'all cause' mortality at 12 months, comparing minimally invasive endovascular Stent Graft treatment to a historical surgical control group.

Dr Fairman reported that patients in the test group who received the Talent Thoracic Stent Graft had a statistically significant reduction in all-cause mortality - 16.1 percent compared to the surgical control rate of 29.8 percent (p= less than 0.001) - using literature-derived figures for the open surgery group.

Aneurysm related mortality in the VALOR trial was 3.1percent at 12 months.

The Talent Thoracic system also had a successful aneurysm treatment rate of 89.2 percent.

This was defined as no aneurysm growth greater than 5mm between 1 and 12 months and the absence of a Type I endoleak.

In addition, the Talent Thoracic Stent Graft system demonstrated 100 percent patency, which is a measure of the graft's ability to resist collapse and remain open for proper blood flow, and there was a 99.5 percent success rate in deploying the Stent graft.

Also, the Stent Graft system used in the study was available in diameters ranging from 22 to 46mm.

Without this wide range of sizes, approximately 25 percent of the test arm patients in the VALOR trial would not have had the minimally-invasive Stent Graft therapy available to them as a treatment alternative.

'These results are excellent and demonstrate that the Talent Thoracic Stent Graft provides substantial reductions in all-cause mortality compared to open surgery for this patient population', said Dr Fairman, chief of the division of vascular surgery, University of Pennsylvania Health System.

'For patients who are considered candidates for open surgery, this minimally-invasive method may provide a potential treatment option'.

Based on the VALOR data, Medtronic submitted its pre-market approval application to the US Food and Drug Administration in March 2007.

The device is awaiting approval.

The Talent Thoracic system has been available outside the USA since 1998, with more than 20,000 implants.

'Each year tens of thousands of people in the USA are diagnosed with life threatening thoracic aneurysms or traumas to the aorta', said Katie Szyman, vice president of Medtronic's Endovascular business.

'For many, it is difficult for them to undergo and survive open surgery because of other serious medical conditions such as coronary artery disease, high blood pressure or diabetes'.

'Also,open surgery is a complex and risky procedure for many elderly patients'.

'Having a minimally-invasive procedure is an excellent alterative for patients and provides physicians with a choice of treatments'.

Medtronic is an international leader in endovascular therapies and currently markets several of the world's leading Stent grafts, including the AneuRx AAAdvantage Stent Graft System for abdominal aortic aneurysms (AAA) in the USA, and the Talent AAA and Valiant Thoracic Stent Graft Systems outside the USA.
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