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Vascutek limb salvage device cleared

This article was originally published in The Gray Sheet

Executive Summary

Temporary Limb Salvage Shunt gains FDA market clearance following less than a week of review. The agency cites the "critical need for such a device" and applicability to combat situations in announcing the clearance Feb. 9. The shunt bridges severed blood vessels to maintain blood flow to injured limbs while patients are transported to surgical facilities. The first-of-its-kind shunt features a self-sealing elastomer that allows for injection of drugs. "This device has been used successfully by other countries and is particularly important to serve our men and women in the Armed Forces who are seriously injured in combat," stated CDRH Director Dan Schultz...
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