When a peripheral nerve is injured or severed and requires surgery to repair, the standard treatment involves manual suturing of the nerve’s outer connective tissue, a somewhat complex process that requires close precision and intense focus.
The nerve repair process just got a lot simpler, however, thanks to a new FDA 510(k) clearance (PDF) for a device that essentially amounts to a piece of Scotch tape that can quickly and effectively rejoin nerve ends.
With the agency’s go-ahead, Nerve Tape is now on track to make its U.S. clinical debut sometime in 2023, according to BioCircuit Technologies, which developed the device in partnership with Virginia Commonwealth University’s Orthopedic Microsurgery Laboratory.
The base of Nerve Tape is a small sheet of submucosa tissue that’s derived from the small intestine of pigs; the use of a biological material is meant to encourage the body’s natural healing processes. Each of the flexible sheets is embedded with rows of tiny hooks, arranged to evenly distribute the tension throughout the tissue surrounding an injury site.
In a repair procedure, the piece of Nerve Tape is merely wrapped around the outer connective tissues surrounding severed nerve ends. Once there, the microhooks grab onto the tissue, ensuring a secure connection between each piece. The tape can be easily unwrapped and repositioned as necessary to properly align the nerve ends.
“The development and clearance of Nerve Tape represents a significant advancement in the treatment of nerve injuries,” said Jonathan Isaacs, M.D., co-inventor of the system and a professor and chair in the Virginia Commonwealth University Medical Center’s hand surgery division. “This product has the potential to offer surgeons a faster, simpler method for achieving a precise, reliable repair of injured nerves.”
As it ramps up production to prepare for Nerve Tape’s commercial launch next year, BioCircuit has assembled a cadre of supply partners.
Most recently, it brought Smithfield Bioscience into the fold. The bioproduct developer—a unit of pork producer and food processing giant Smithfield Foods—was tapped (PDF) by BioCircuit to provide the porcine small intestinal submucosa tissue that makes up the base of the device.