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Rotator cuff surgery is continually evolving, with breakthroughs in technology reshaping the way surgeons reattach torn tendons to the head of the humerus. Newly developed options are designed to address a significant shortcoming in the procedure by creating better, longer-lasting repairs.
“About 20% of all rotator cuff repairs fail,” said Saif Khalil, Ph.D., CEO and Founder of Aevumed, which recently launched the Phantom-LP anchoring system to empower surgeons to adjust suture tension mid-procedure. “It’s correlated to the size of the tear. If the tear is large, the 20% failure rate can increase to 50%. That means roughly half of those patients need to undergo another surgery.”
The sports medicine market is filled with recently introduced solutions that have the potential to reduce re-tear rates and improve patient outcomes.
ZuriMED Technologies has introduced Surgical-Fiberlock technology, a novel suturing system designed to bolster weak tissue and prevent suture cut-through at the repair site. Anika Therapeutics is expected to launch a hyaluronic acid (HA)-based rotator cuff patch system in 2024 to capitalize on what the company sees as an $850 million market.
Inovedis closed a $4 million Series A funding round in October to support the commercial launch of the SINEFIX implant in the U.S. and a clinical study that will generate data needed for the device’s CE Mark in Europe. That same month, Tetrous was issued a U.S. patent for the EnFix family of demineralized cortical bone fiber implants, which enhance healing at the tendon-to-bone interface.
It’s clear that new entrants into the market, innovations from existing companies and increased interest in minimally invasive surgical techniques are transforming a space that’s ripe for significant growth.
Beyond Traditional Sutures
At the heart of many of these advancements is the transformative progress in suture anchor technology. Traditional challenges, such as anchor pullout, have spurred advancements in the design of these devices. Modern anchors are characterized by smaller profiles, increased strength and greater bioabsorbability. These features contribute to improved fixation of suture to bone, a critical aspect in ensuring the stability and success of rotator cuff repairs.
Innovations in suture anchor technology extend beyond mechanical aspects to address intraoperative adjustability. The ability to fine-tune suture tension during surgery is a significant benefit. Surgeons can make real-time adjustments to achieve optimal tension, mitigating the risks associated with overly tight or loose sutures. This dynamic tension adjustment enhances the mechanical aspects of the repair and aligns with the trend toward personalized and adaptable solutions in orthopedics.
“Dynamic tension adjustment is a game-changer, offering surgeons the flexibility to optimize tendon adherence to bone in individual patients and reduce the likelihood of repair failure,” Dr. Khalil said.
Protecting bone integrity has also become a focal point in suture anchor technology. Traditional anchors often exert pressure or stress directly on the bone of the humerus. Dr. Khalil said Phantom-LP addresses this concern by containing sutures within the anchor. This not only ensures a more secure fixation but also protects bone, particularly when bone quality could jeopardize the tendon repair.
“Soft bone, which a lot of patients have, could cause the suture to loosen,” Dr. Khalil said. “The Phantom-LP directs the tension to the internal side of the anchor, which ultimately protects the bone.”
Surgical techniques for placing suture anchors have transformed over the years, noted Andy Carter, Ph.D., Founder and Director of Tetrous. Choices now range from double-row and single-row techniques to high-strength sutures and tapes. Despite these innovations, the clinical outcomes of rotator cuff repair have remained somewhat stagnant.
Dr. Carter pointed to the development of overlay patches as a notable trend in the field. He said these patches, while effective for a subset of patients with thinning tissue and bone in the rotator cuff area, fail to address the broader challenges associated with reattaching tendon to bone.
That’s where Tetrous’s EnFix RC comes into play. In an uninjured shoulder, the site where the tendon connects to bone (the enthesis) includes a transitional region with fibrocartilage. This region shows variations in how tissue cells are organized and how they work mechanically.
These natural variations help to smooth the transferring force between tendon and bone, which have very different levels of stiffness. This dynamic prevents the build-up of stress in one specific area that could lead to a tear.
“When the rotator cuff tendon detaches from the humerus, it never fully heals and reforms after it’s been reattached — no matter how well an overlay patch works or how well sutures are patterned,” Dr. Carter said.
Current methods that are used to reattach the tendon often result in inadequate healing of the enthesis and lead to the formation of scar tissue, according to Dr. Carter. He said EnFix RC encourages healing that begins at the bone and moves toward the tendon, mimicking how the enthesis naturally forms during embryonic development.
Dr. Carter believes this innovative procedure-specific implant, which recently hit the market in the U.S. and Australia, sets a new standard in rotator cuff repair by facilitating enthesis healing. Allowing cells and local factors to migrate toward the interface between bone and tendon provides a promising solution to the persistent challenges associated with tendon reattachment.
“How do you make the tendon act how it did before anything happened to it?” said John Bojanowski, Chief Sales and Marketing Officer at Tetrous. “That’s where products like ours come into play.”
Inovedis has approached the problem of high re-tear rates with the SINEFIX implant, which is designed to make rotator cuff repair easier and faster. The implant is placed with a two-step technique that is intended to maintain blood circulation to the repair area, said shoulder surgeon Stefan Welte, M.D., Founder of Inovedis and inventor of SINEFIX.
“There’s an old saying in surgery, ‘If there’s no blood, there’s no life,’” Dr. Welte said. “Implants that share the force of the tension between bone and tendon and maintain blood circulation provide better results than the use of suture alone.”
Promoting Personalized Care
Companies are also exploring the untapped potential of biologic agents, growth factors and stem cell therapies to further address high repair failure rates. While the current SINEFIX design utilizes PEEK material, Inovedis intends to explore the use of biologic materials that enhance healing.
“Rotator cuff repair hasn’t changed much in 20 years, and maybe we need to look to biologics for the next wave of innovation,” Dr. Welte said.
The use of demineralized bone fiber (DBF) — a material widely employed in spine surgery — is part of the appeal of EnFix RC, which is crafted with patented 100% cortical bone-derived DBF allograft technology. Dr. Carter said the device is shaped like a top hat with the DBF fibers fitting into the awl hole that’s used for suture anchor insertion. EnFix RC securely holds the device in place, kickstarting a healing process driven by cellular and endogenous factors.
DBF’s unique properties represent a shift toward enhancing tissue healing by creating a cell-friendly environment, Dr. Carter noted. The potential benefits of this approach lie in restoring tissue at the repair site and potentially bringing it back to its native state. It’s a holistic approach that could improve overall patient outcomes.
“We saw in the literature and in our studies that treating bone with DBF could promote tendon reattachment,” Dr. Carter said. “DBF starts the healing process from bone to cartilage.”
Aevumed is combining innovation with the body’s natural healing powers to develop a 3D-printed scaffold, Dr. Khalil said. Unlike conventional options, this scaffold allows for simultaneous onlay and interposition placement and is tailored for full-thickness tears, offering a leap forward in biological repair augmentation.
The collagen-based structure features controlled porosity and ensures mechanical integrity. It also serves as an efficient delivery system. This dual-pronged strategy aims to significantly elevate the success rates of rotator cuff repairs by fostering a conducive environment for tissue healing.
“The exceptional biocompatibility of our scaffold is rooted in collagen, a natural protein known for seamlessly integrating with surrounding tissue,” Dr. Khalil said. “This biologic harmony not only enhances strength but also ensures a seamless integration with the patient’s tendon and bone.”
The use of collagen allows implants to become part of the body’s natural healing process, aligning with the broader trend toward regenerative medicine. Aevumed’s 3D-printed material also enhances the mechanical integrity of the scaffold to improve the durability of tendon repairs.
“This technology allows us to create implants that seamlessly integrate with the patient’s unique anatomy,” Dr. Khalil said. “It optimizes current outcomes and lays the groundwork for potential future patient-specific solutions.”
Although Aevumed’s current implants are not explicitly designed to be patient-specific, they embody a high degree of anatomical specificity. The implants are tailored to the unique characteristics of the rotator cuff to ensure an exact fit and increase the likelihood of successful repairs. “The potential for personalized rotator cuff repair is an avenue for future development, one that holds the promise of elevating the precision of surgical interventions,” Dr. Khalil said.
For Tetrous, the focus is on creating a procedure-specific implant that integrates seamlessly with existing surgical techniques, Bojanowski noted. He added that while patient-specific applications are not in the company’s immediate plans, the evolving landscape of medical technology suggests potential future developments in this direction.
Advancing Arthroscopic Techniques
Minimally invasive rotator cuff repair is redefining the patient experience and contributing to improved outcomes. Smaller incisions lead to less postoperative pain and quicker recoveries, marking a departure from the traditional open surgeries that characterized rotator cuff repairs in the past. Dr. Khalil said this shift has been organic, gaining momentum over the past decade and fundamentally altering the landscape of patient care.
“We’ve embraced this trend in our product design philosophy,” Dr. Khalil said. “All of our products — the innovative scaffold and advanced anchors — are purposefully crafted for arthroscopic procedures, aligning seamlessly with the prevailing trend toward minimally invasive surgical techniques.”
Dr. Carter noted that Tetrous’ commitment to making the surgeon’s task easier during rotator cuff repair is at the heart of the company’s approach to producing technology that advances arthroscopic surgery. Recognizing the intricate nature of these procedures, the company has developed Enfix RC with a holistic perspective in mind.
SINEFIX is also designed to make rotator cuff repair easier and more efficient for surgeons who don’t perform the procedure on a consistent basis. “It isn’t always easy for surgeons who don’t specialize in rotator cuff repair to handle and place suture anchors,” Dr. Welte said. “Tying knots around two, three or four sutures requires some skill. It can be quite time-consuming. The easier the technique, the less room there is for error.”
The convergence of groundbreaking technologies, holistic approaches and a renewed focus on biologic solutions hold the promise of transformative experiences for surgeons and their patients and could reshape the future of rotator cuff repair.
“We need to focus more on repair techniques and biologic treatments and less on biomechanical devices,” Dr. Welte said. “The body’s healing process is complex and we’re still far away from understanding its mechanisms. We need to discover how to give the body what it needs in the best way possible. Its biology is perfect. We just need to improve upon it.”
