The FDA has 510(k) cleared Biorez, Inc.’s’ BioBrace™ Implant Surgical mesh, a soft tissue augmentation implant.
FDA Clears Biocomposite Surgical Mesh Implant From Biorez
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In a May 17, 2021, press release, the company said the BioBrace is, “highly differentiated” in that, unlike traditional implant materials that are either synthetic or biologic, its implant is a biocomposite of both. The proprietary biocomposite architecture features a “highly porous type 1 collagen matrix reinforced with bioresorbable PLLA (poly-L-lactic-acid) microfilaments.”
In other words, the device reinforces, regenerates, and then resorbs.
As a result, the company cites studies showing “rapid cellular infiltration and new tissue regeneration” by 6 weeks; rotator cuff repair as strong as native tendon by 12 weeks, and 180% thicker tendon compared with non-operative control at 12 weeks.
Faster Recovery, Reduced Re-injuries
“We expect BioBrace to be a game-changing technology for surgeons seeking to augment their repairs mechanically and biologically,” said Kevin Rocco, Biorez founder and CEO. “Our goal is to help patients return to full activity sooner, and potentially reduce re-injuries.”
Indications
The device, according to FDA documents, is intended for use in general surgical procedures “for reinforcement of soft tissue where weakness exists.” The implant is also intended “for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.”
The sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
However, the device is not intended to replace normal body structures or provide full mechanical strength for those reinforcements.
Large Biologic Matrix
The implant, states the FDA clearance documents, is composed of a “highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn.”
It is 80% porous, with average density of 0.2 grams/cm3, and median pore diameter of 19 μm. “The highly-porous collagen sponge comprises the majority of implant surface area (0.7m2/gram) versus the PLLA filaments alone (0.2m2/gram), creating a large biologic matrix for cellular ingrowth.”
The implants are approximately 3mm thick, provided in two rectangular sizes of 5 x 250mm and 23 x 30mm, are single-use and supplied sterile.
Physical characteristics of the implant were measured and compared to commercially available Regeneten (Rotation Medical’s Collagen Tendon Sheet) and Arthrex FiberTape (Internal Brace) devices and were found to be substantially equivalent by the agency.
Biorez, Inc. was founded in 2016 and is located in New Haven, Connecticut.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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