Many Americans likely have seen news reports of the alarmingly high number of amputees as a result of the war in Iraq and the subsequent challenges these soldiers face when returning home without the use of one or more of their extremities.
Now, with the FDA's report on Friday that it has approved a shunt designed to help salvage limbs injured by some sort of trauma, it is hoped that more soldiers will be returning home with limbs intact. And, ultimately, the shunt will be launched commercially for those trauma patients who arrive each day at emergency rooms in the U.S., Mac Ritchie, VP of Vascutek USA (Ann Arbor, Michigan), told Medical Device Daily.
The FDA has given 510(k) clearance to the Temporary Limb Salvage Shunt (TLSS), made by Vascutek (Renfrew, Scotland), parent company of Vascutek U.S.
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.
Ritchie 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 "several" 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.
Although the device was designed near the end of Desert Storm, the route to FDA clearance actually began when Ritchie said he was on a typical business trip to Vascutek's facilities in Scotland. He said he "saw the device on the shelf" and wanted to know what it was.
He said he was told that it had been used by the British military but that, with the close of Desert Storm hostilities, it was not pushed forward by the company commercialization.
Then, with the war in Iraq and the renewed obvious need, Ritchie said that he began talking to various people in the U.S. concerning the device about a year and a half ago. And he was then energized to bring the device to the U.S. military as a result of a visit Walter Reed Hospital (Washington), the famous U.S. Army hospital.
And there is a particular need growing out of the current conflict, he told MDD.
Because currently the trunk of a soldier's body is protected by heavy body armor — unlike in the Korean War, Viet Nam War and previous conflicts — the legs receive the most frequent trauma.
Ritchie eventually teamed up with a lieutenant colonel, Todd Rasmussen, who also happens to be a vascular/trauma surgeon based at Lackland Air Force Base in San Antonio. Besides being a physician, Rasmussen had been to Iraq on "numerous tours of duty," according to Ritchie.
"So, he was the driving force in sitting down with the FDA," Ritchie said, noting also that Rasmussen "doesn't take no for an answer very well."
He went to the FDA and "kept appealing to the proper people" that nothing similar was available to physicians on the battlefield.
Ritchie said the FDA required only animal studies for the 510(k) clearance, and those were completed 12 years ago. All the materials involved in the device "had all been used individually, just never put together in a simple format like this," Richie 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.
Rasmussen told MDD, "We think that this device will be a useful adjunct in the management of extremity vascular injury and will be helpful in improving our ability to salvage injured limbs." While "the concept has been available for some time," he said, Vascutek's device is designed especially for vascular trauma, unlike other devices, and he expects this will offer advantages.
"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. "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."
Vascutek, a business of Terumo, makes polyester composite materials used in prosthesis products and other graft products used to treat damaged arteries.