Rotator cuff surgery has a problem that surgical technique alone has not solved. The failure rate for rotator cuff repair has been reported to be between 20% and over 90%, depending on tear size, patient age, and tissue quality. The most common reason for that failure is structural failure at the surgical site, specifically the inability of the repaired tissue to hold its position while biologic healing progresses. Synthasome was founded in 2003 to address that problem from a materials science perspective.
Synthasome is an advanced orthobiologics company dedicated to the creation of products that aid in soft tissue repair, regeneration, and replacement. Founded by a team of bioengineers and orthopedic specialists with a shared objective of using tissue engineering and functional bioengineering to address unmet clinical needs in orthopaedic and musculoskeletal applications, Synthasome has developed its first FDA 510(k) cleared product, X-Repair, through a series of federally funded research projects. Synchrocare distributes Synthasome products as part of its national specialty medical device portfolio.
What X-Repair is and how it works
X-Repair is a proprietary and patented surgical mesh fabricated from poly-L-lactic acid, a slowly degradable synthetic polymer with an established safety record across many clinical and implantable device applications. The mesh is woven to produce high tensile stiffness and strength, with mechanical properties specifically designed to be similar to native human tendon. That similarity is the foundation of how X-Repair works.
When sutured over torn or degenerative tissue as reinforcement, X-Repair defrays the load placed on the sutures and acts as a scaffold for tissue that is too fragile to maintain a strong connection to bone. The implant is biocompatible and allows rapid tissue ingrowth throughout the mesh structure. It degrades slowly over 12 to 24 months, maintaining approximately 90% of its strength at 12 months. That slow degradation rate is deliberate: it allows biologic repair to proceed and establish stability before the mechanical support of X-Repair diminishes. Because X-Repair degrades in the body, surgical removal is not required.
X-Repair is stiffer and stronger than other augmentation products, with mechanical properties equivalent to human tendon and high suture retention strength that allows those properties to be fully imposed at the repair site.
Clinical applications across five tendon and soft tissue indications
X-Repair is FDA 510(k) cleared for reinforcement of soft tissues repaired by suture or suture anchors, including reinforcement of rotator cuff, patellar, Achilles, biceps, and quadriceps tendons. The device is not intended to replace normal body structure or provide the full mechanical load-bearing function of the tendon. Its role is augmentation: supporting the repaired tissue while biologic healing establishes the structural integrity that the repair ultimately depends on.
X-Repair has been used in open, mini-open, and arthroscopic procedures. In open and mini-open approaches, the addition of X-Repair extends procedure time by approximately 10 to 15 minutes. Arthroscopic use requires additional technical expertise and adds approximately 20 to 30 minutes to the procedure. The majority of clinical cases performed with X-Repair have been done arthroscopically. The device is available in a range of sizes to accommodate variation in tear size and patient anatomy, addressing a large range of tendon and soft tissue defects requiring surgical repair.
What distinguishes X-Repair from alternative augmentation products
Most augmentation products used in tendon repair are allogeneic, derived from human cadavers, or xenogeneic, derived from animals. Both carry potential risks of infection and greater variability in product properties compared to a synthetic device manufactured under controlled conditions. X-Repair is fully synthetic, eliminating those risks while delivering mechanical properties that match native tendon more closely than existing alternatives.
X-Repair should not be cut during surgery, as it is a woven material. It is available in a broad range of sizes to meet the range of surgical needs without requiring intraoperative modification. Synthasome continues to develop new orthobiologics products with applications in tendon, ligament, and articular cartilage repair and regeneration, building on the tissue engineering and bioengineering foundation that produced X-Repair.
HS Fiber and HS Split Stitch: sutures designed for arthroscopic precision
Alongside X-Repair, Synthasome produces two sutures designed to support the demands of arthroscopic orthopedic surgery. HS Fiber is a non-absorbable braided suture made from fibers of ultra-high molecular weight long-chain linear polyethylene. The Core-loc design delivers high knot strength while the eBraid design provides superior handling characteristics. Four colours with a triaxial pattern give the suture outstanding visibility and distinguishing features that are particularly important for suture management in arthroscopic procedures.
HS Fiber is available in five catalogue configurations covering different colour combinations and needle options, with tensile strengths ranging from 42.8 to 78.1 lbf and knot pull strengths from 30.9 to 38.0 lbf. The HS Split Stitch uses HS Fiber with both ends returned to a half-circle taper needle, providing an additional configuration for surgeons who prefer this format in their repair technique.
To learn more about Synthasome products available through Synchrocare, visit www.synchrocare.com.