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Medtronic

This article was originally published in The Gray Sheet

Executive Summary

Medtronic Haft collagen-impregnated aortic valved conduit is available worldwide at a list price of $4,995. The product of a licensing agreement between Medtronic and Meadox Medicals, the device combines a Medtronic Hall mechanical heart valve with a Meadox 13 cm-long Hemashield tapered, woven, polyester conduit and "is used by surgeons to replace a diseased or damaged aortic valve and the ascending aorta," Medtronic says. The device offers a larger diameter than other conduits on the market; it is being sold in seven sizes, ranging from 21 mm to 33 mm in diameter. A premarket approval application supplement for the device was approved by FDA May 12, approximately eight months after the application was filed. St. Jude began sales of its collagen- impregnated aortic valved graft in March. The device combines a St. Jude mechanical heart valve with Meadox' Hemashield
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