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A sutureless device for peripheral nerve repair could be available on the market in the coming months.
The Food and Drug Administration has authorized a polymer-based device developed by medical technology company Tissium, which has its US office in Cambridge. The authorization, announced Tuesday, will give physicians a new method for treating peripheral nerve injuries.
“This approval is really a game-changer for patients with peripheral nerve injuries,” said Jeffrey Karp, a Tissium co-founder who developed the device’s technology. “For the first time, surgeons now have a sutureless, bio-inspired option that can really simplify the procedure while improving outcomes.”
Peripheral nerve injuries impact hundreds of thousands of individuals every year. Though they are typically treated using microsurgical sutures, this approach often poses complications — including scarring and the possibility of additional trauma. Tissium’s device, which relies on a light-activated surgical polymer instead of sutures, mitigates some of the risks associated with traditional methods of repair.
The device includes a chamber and fixation tool composed of the same biodegradable, light-activated surgical polymer. It works by inserting two nerve ends into the chamber and then applying light to the fixation device — thereby allowing the chamber to interlock with the tissue surface and repair nerves without the need for sutures. The device mimics how certain creatures in nature adhere securely to wet environments, according to Karp.
Kyle Eberlin, a peripheral nerve surgeon at Mass General Brigham who is not affiliated with Tissium, told STAT that the device’s most innovative aspect is its light-activated polymerization. “It’s a unique way to secure the device at the site of the nerve repair,” he said.
Along with biotech veteran Bob Langer, Karp developed the device’s original polymer material as a postdoctoral researcher at Massachusetts Institute of Technology. When he opened his own lab at Brigham and Women’s Hospital, Karp continued developing the device alongside Maria Pereira, then a Ph.D. student.
“When proper peripheral nerve repair is not achieved, it can have a strong impact on the quality of life of patients. They don’t recover sensation. They don’t recover motor function. And that’s what we are trying to bring to the market,” said Pereira, who co-founded Tissium and now serves as its chief innovation officer. The FDA’s authorization marks the first approval of a device built with a novel polymer platform since 2007.
The potential risks associated with suturing — including being technically invasive, time-intensive, and causing scarring and additional trauma — has meant “the world is pushing towards a sutureless concept,” according to Neill Yun Li, a peripheral nerve surgeon at Duke University School of Medicine who is not associated with Tissium.
But Li cautioned that efficacy needs to be prioritized in developing such devices due to the nature of nerve injuries. Nerves don’t have to heal at just the site of repair, but instead must heal all the way down to their sensory and muscle fibers, which can take years, Li explained.
“We’re at a crossroads of ensuring that these devices offer a regenerative presence that’s better than suture itself, because we don’t want to put something on there that’s easy to apply, but then inhibits regeneration,” Li told STAT. He added that the closed environment created by Tissium’s device could potentially affect the cellular repair process. When nerves are sutured together, they are completely open to the environment to heal. But if they are surrounded by a polymer, macrophages and Schwann cells — the primary reparative cells — may not be able to enter, according to Li.
Another concern is the rigidity of the device’s solidified polymer, according to Eberlin. The polymer’s lack of relative flexibility could pose an issue, given that nerve repairs often take place near joints, where a lot of movement occurs.
But Pereira countered the concerns raised by Li and Eberlin, pointing to preclinical and clinical data on the device’s effectiveness. A recent clinical study used Tissium’s device to treat 12 patients with nerve injuries to their fingers. The device achieved 100 percent procedural success, allowing patients to regain full extension of their injured fingers and record no pain a year after the procedure.
In addition to the device’s clinical success, a key benefit is that it could level the playing field for experienced and inexperienced surgeons, according to Eberlin. A physician who has not had significant experience in nerve repair could achieve good technical results using the device, Eberlin explained.
Tissium’s device will be available to physicians and patients in the coming months, according to Pereira. And the company is currently working on applying its tissue repair technology to solutions for other health problems, including hernias and cardiovascular issues.
“We really see this as a platform technology — and basically this first technology as a good first validation of what we can do,” Pereira said. “We believe we can bring a new standard for tissue repair.”