US human clinical trials are set to begin of Medtronic Inc's second-generation Talent LPS(tm) endoluminal stent-graft system, for treating abdominal aortic aneurysms, following US Food and Drug Administration approval of an investigational device exemption.
The stent-graft system, produced by Medtronic AVE subsidiary World Medical Manufacturing Corp, incorporates a new, thinner medical grade polyester graft material that allows the implant to be introduced into the vascular system with a 20-22 French catheter, about 6.6 to 7.3 mm in diameter.
The new graft material is thinner, but as strong as materials previously used, according to Howard Leonhardt, Chief Executive Officer of World Medical. Long-term durability is the overriding concern in stent-graft systems, he said, adding that the device is designed "to provide a reduced introduction profile without sacrificing long-term durability".
The Talent LPS system has been available commercially in the European market since November 1998. The current trial involves a total of 100 patients at 13 centres.
For further information, contact: Chris O'Connell, Investor Relations, Medtronic Inc, 7000 Central Avenue, NE, Minneapolis, MN 55432-3576, USA; tel: +1-612-514-4971; Internet address: http://www.medtronic.com; or World Medical Manufacturing Corp, Sunrise, Florida, USA; Internet address: http://www. worldmedical.com
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