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The US Food and Drug
Administration (FDA) cleared for US marketing a vascular shunt, a medical device
that can help save the arms and legs of soldiers critically injured in combat as
well as individuals in other trauma settings and emergency situations.
The Temporary Limb Salvage
Shunt (TLSS), made by Vascutek Ltd. (Renfrew, Scotland), was reviewed by FDS in
less than one week because of the critical need for such a device, an FDA
release stated.
"This device offers surgeons a
new tool to potentially avoid the need for limb amputation following traumatic
injury," said Daniel Schultz, M.D., director, Center for Devices and
Radiological Health, FDA. 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."
The device works by connecting
together the ends of a severed blood vessel, providing a bridge or shunt around
the damaged area and restoring blood flow to the injured limb. It can be
implanted on the battlefield and other remote areas to bypass damaged blood
vessels and temporarily maintain blood flow to the injured limb until the
patient can be transported to a surgical facility.
The TLSS is a tube formed from
two layers of plastic. The device has several features that optimize its use in
a trauma situation, including a self-sealing elastomer membrane that permits
drugs to be injected directly into the shunt without loss of blood; bevelled
ends that facilitate quick and effective placement of the device within the
severed blood vessel; graduated markings that provide visual confirmation of
proper device placement; and extra reinforcement in the centre of the device so
it can be cut to a shorter length if needed.
To facilitate this accelerated
review process, the device manufacturer worked in close collaboration with FDA's
Division of Cardiovascular Devices after discussion of the need for the device
with the US Air Force. There are currently no other devices specifically
available for treating injuries of this nature.
(Ref : Chronicle Pharmabiz
dated February 22, 2007).
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