Vascutek USA (Ann Arbor, Michigan) last month received FDA clearance to the Temporary Limb Salvage Shunt (TLSS), made by its parent company Vascutek (Renfrew, Scotland). Significantly, the agency said it reviewed the device “in less than one week because of the critical need for such a device” — as well as the lack of any other such product on the market.
Mac Ritchie, VP of the company, said that are other “shunts available in the U.S. by a variety of manufacturers . . . are not vascular shunts. Our device was designed to be a vascular shunt, period — no other use.”
The FDA said the TLSS works by connecting the ends of a severed blood vessel, thus providing a “bridge or shunt” around the damaged area and restoring blood flow to the injured limb. The device can be implanted on the battlefield and other remote areas in order to bypass damaged blood vessels and temporarily maintain blood flow until the patient can be transported to a surgical facility.
The TLSS is a “tube formed from two layers of plastic,” according to the agency, and has features that make it optimal for use in cases of trauma. These include: a self-sealing elastomer membrane that permits drugs to be injected directly into the shunt without loss of blood; beveled 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 center of the device so it can be cut to a shorter length if needed.
All the materials involved in the device “had all been used individually, just never put together in a simple format like this,” Ritchie said. He noted that Vascutek’s first priority now is to get the device to soldiers in all branches of the Armed Forces, and the company is in the process of going through the military procurement process. That will be followed by commercialization in the U.S.
“This device offers surgeons a new tool to potentially avoid the need for limb amputation following traumatic injury,” said Daniel Shultz, MD, director of the FDA’s Center for Devices and Radiological Health.
Vascutek, a business of Terumo, makes polyester composite materials used in prosthesis products and other graft products used to treat damaged arteries.