BioBrace^® Reinforced BioInductive Implant: Backed by Clinical Evidence

• BioBrace^® offers a promising alternative to non-absorbable suture augmentation by:
  • Reducing stress shielding
  • Avoiding complications from large polymer anchors
  • Supporting early mobilization and return to sport
• Early outcomes show excellent functional recovery, minimal complications, and high patient satisfaction.

• AirSeal significantly lowers etCO₂ in patients undergoing LPN, which can therefore impact recovery and complication rates

• This technique offers a biomechanically robust and biologically active alternative to traditional MPFL reconstruction.
• The reinforced bioinductive implant provides early mechanical strength and supports tissue healing.
• The double-bundle docking technique mimics native MPFL anatomy.

• Improved intraoperative lung compliance and peak inspiratory pressures
• Decreased post-op pain over 5 days both at rest and on exertion
• Low IAP was associated with an earlier time to pass flatus post-op

Study inclusion criteria: High-risk patients

• Large (>3cm) and massive (>5cm, >= 2 tendons) rotator cuff tear
• Anterior to Posterior tear >2.5cm
• Infraspinatus fatty atrophy
• At least one co-morbidity

Lower retear rate in rotator cuff repair with BioBrace^® augmentation

46/49 (94.1%) patients augmented with BioBrace^® healed at minimum 1 year follow-up (avg: 26.1 months).¹

According to a white paper based on meta-analysis and a retrospective review of data, rotator cuff retear rates after surgical repair can range from 7.2% to 94% and most rotator cuff repairs fail within the first 6 months.²

Improved patient reported outcomes and range of motion

PROMs/ROM outcomes improved, VAS, and ASES scores statistically significantly improved at all time points (3m, 6m, 12cm) compared to baseline (p < 0.001).

Citations

¹McMillan S, Ford E, Bishai SK. Favorable Early Patient-Reported Outcome Measures and Clinical Retear Rates in High-Risk Rotator Cuff Repairs Augmented with a Reinforced Bio-Inductive Implant at One-Year Follow Up

²A Retrospective Chart Review to Evaluate Clinical Outcomes of the BioBrace^® Implant, https://www.conmed.com/-/media/conmed/documents/clinical/retrospectivechartreviewtoevaluateclinicaloutcomesofbiobrace_whitepaper.ashx

• Significantly lower Clavien-Dindo III-IV complications
• Significantly reduced general and shoulder pain at 12-24h post-op
• Reduced LOS

• This technique offers a streamlined, reproducible approach to MPFL repair augmentation.
• BioBrace^® can provide both mechanical reinforcement and biologic integration, which could support early mobilization and return to activity.
• The single-incision method improves surgical control and may reduce complications associated with graft malposition or overtensioning.
• Preliminary outcomes are promising, with no recurrent dislocations and full return to activity by 6 months post-operatively.

• AirSeal results in shorter operative time, reduced hospital stays, and fewer major complications

• BioBrace^® augmented MPFL repairs provides similar strength to an intact MPFL.
• Augmentation with BioBrace^® provides an alternative solution for patient indications where a reconstruction is not necessary, but surgical intervention is required.

• Significantly lower rates of subcutaneous emphysema
• 12hr post-op pain scores significantly lower

• Bioinductive scaffold augmentation in UCL repair is biomechanically feasible and enhances initial joint stability.
• May allow for earlier rehabilitation while avoiding risks associated with nonabsorbable materials.
• Further clinical and comparative studies are needed to assess long-term outcomes and validate superiority over existing techniques.

• BioBrace^® augmentation in BTB allograft ACLR is a promising technique.
• Technique is reproducible and adaptable.
• Enhances graft strength and healing without donor site morbidity.

• Significantly lower subcutaneous emphysema rate than the conventional group
• Significantly lower etCO₂, PaCO₂ at the end of the operation, lower tidal volumes and frequency of scope cleaning
• Significantly lower post-op pain scores at 8hr, 12hr, and at time of discharge

• BioBrace^® augmentation in ACL reconstruction is a promising technique for improving graft strength and healing, especially in MLKI.
• Offers a balance of mechanical reinforcement and biological integration.
• Technique is versatile and reproducible, with potential applications beyond ACLR.

• Comparable Pullout Strength: In a biomechanical cadaveric model comparing the BioBrace^® implant and a semitendinosus graft for augmenting MPFL repair, there was no statistically significant difference in pullout strength between the two groups. This suggests that the BioBrace^® implant can offer comparable mechanical stability to traditional graft methods.
• Challenges Addressed by BioBrace^®: The BioBrace^® implant addresses limitations of current methods by providing both healing properties to stimulate native tissue healing and biomechanical strength to support MPFL repair. This dual functionality aims to reduce the risk of recurrent patellar instability and progressive soft tissue and cartilage injuries.
• Advantages Over Semitendinosus Graft: The semitendinosus graft showed a higher failure rate (67% by anchor pullout) while BioBrace^® provided consistent fixation with minimal failures. This highlights BioBrace^® as a reliable alternative for enhancing MPFL repair outcomes.

• BioBrace^® augmentation is a promising technique for ACL reconstruction.
• Technique is reproducible and adaptable to various graft types.

• MRI at 1 year has demonstrated restoration of the native biceps tendon and showed an increase in tendon diameter from 5mm at pre-op to 8mm at 1 year post op.
• Enhanced Healing: BioBrace^® promotes a beneficial healing environment and provides structural support.
• Mechanical Support: Provides load-sharing strength at time zero, reducing re-rupture risk.
• Versatility: Suitable for both acute and chronic distal biceps injuries.
• Improved Outcomes: Early results show promising restoration of tendon strength and diameter.
• Future Potential: BioBrace^® may be widely applicable in biceps tendon rupture.

• Shorter operative times by 12.3 minutes
• Shorter length of hospital stay by 0.5 days
• Lower odds of Clavien-Dindo complications

• Enhanced Healing: BioBrace^® promotes rapid cellular infiltration and tissue growth.
• Mechanical Support: Provides load-sharing strength at time zero, reducing re-rupture risk.
• Improved Outcomes: Early results show promising restoration of tendon strength.
• Future Potential: BioBrace^® may be widely applicable for various tendon and ligament repairs.

• High Re-Rupture Rates in Achilles Tendon Injuries: Achilles tendon ruptures account for 20% of all large tendon ruptures, with re-rupture rates ranging from 2.1% to 8.8%. Ineffectual management can lead to significant loss in push-off strength and overall ankle function, highlighting the need for improved treatment strategies.
• Promise of BioInductive Augmentation in Achilles Tendon Repair: The field of orthopedic surgery is increasingly interested in bioinductive augmentation to enhance outcomes in Achilles tendon repairs, especially in patients with poor tendon tissue. The BioBrace^®, reinforced bioinductive implant, made of type I collagen and bioresorbable PLLA microfilaments, provides immediate strength and promotes new tissue growth during its resorptive phase.
• Innovative Technique Using BioBrace^® for Achilles Tendon Repair: A technique for augmenting acute Achilles tendon repair with the BioBrace^® reinforced bioinductive implant shows promise. This approach provides additional structural support and promotes new tissue growth, potentially benefiting active individuals aiming for a quick return to physical activities. Additionally, the cost of revision surgery for failed soft tissue repairs, such as Achilles tendon ruptures, is significant in terms of healthcare dollars and toll on the patient. Given this, for the correctly indicated patient, using an RBI for soft tissue reinforcement can add significant benefit and decrease failures in patients with poor tissue quality.

• Lower operative time (107.5 min in AirSeal group vs. 120 min in SI group)
• Lower complication rates
• Decreased perioperative blood loss (1.45g/dL vs 2.2g/dL)
• Reduced warm ischemia time (18 min vs. 20 min)

• Had a 40 min shorter operative time and 1-day shorter LOS than the 15mmHg group
• Had fewer patients with ileus (10% vs. 30%) compared to the 15mmHg group
• Passed flatus 1 day earlier and stooled 1.5 days earlier than 15mmHg group
• The study found that patients in the 15mmHg AirSeal group had a higher risk of paralytic ileus post robotic cystectomy and robotic intracorporeal urinary diversion

• Procedures in AirSeal group were 12.6% shorter in duration
• Patients in AirSeal group had fewer episodes of nausea (2% vs 10%)
• Trend toward less pain in the AirSeal group within the first 24 hours after surgery

• The BioBrace^® effectively augmented the repair of a chronic Achilles tendon rupture, promoting both mechanical stability and biological healing.
• Early mobilization was possible due to the strength of the repair construct.
• The implant showed promising integration and tissue regeneration on imaging.
• This case supports the potential of biocomposite scaffolds in managing complex tendon injuries, though larger studies are needed for validation.

• The AirSeal system significantly reduced the frequency of scope cleaning (p=0.016)
• Time to disappearance of SCE around surgical cavity was significantly shorter in the AirSeal group (p=0.019)
• When suctioning mist/smokes produced by an energy device, AirSeal prevented narrowing working space and greatly contributed to wide and clear visibility

• The BioBrace^® scaffold provided both mechanical support and biological integration, addressing key failure points in rotator cuff repair.
• Imaging and arthroscopic findings confirmed scaffold incorporation and tissue remodeling.
• The patient achieved near-normal shoulder function at 1-year post-op.

• Significantly lower post-op pain scores
• Improved ventilation - reduced etCO₂ & PIP, reduced MAP

• Trends toward lower pain scores at discharge or 24 hours
• Statistically lower PIP (peak inspiratory pressure)
• Statistically lower etCO₂

• Lower inspiratory plateau pressure, lower minute volume, lower ETCO₂, lower CO₂ elimination rate, higher static compliance
• Improved cardiopulmonary parameters
• Some studies showed decreased complication rates at low pressure

• BioBrace® offers a fully resorbable scaffold that supports both early mechanical stability and long-term biologic healing.
• Augmentation is particularly suited for revision cases and large/massive tears with poor tissue quality.

• Enhanced Healing: BioBrace^® scaffold promotes soft-tissue regeneration, improving recovery outcomes.
• Mechanical Support: Provides necessary structural support during the healing process.
• Versatile Application Suitable for both acute and chronic MCL injuries, offering flexibility in treatment options.
• Early Mobilization: Allows for early range of motion and weight bearing, facilitating quicker rehabilitation.

• Lower incidence of post-operative shoulder pain
• Lower severity of global pain at 4, 8, and 24 hours/li>
• Significantly lower etCO₂
• Significantly lower Peak Airway Pressure
• Significantly lower systolic blood pressure
• Significantly faster recovery
• 98% of patients were discharged within 2 days vs. 75% of patients in the standard group

• BioBrace^® is a novel bio-composite scaffold combining:
  • Type I collagen (bioinductive, 80% porous) designed to induce new tissue ingrowth for thicker tendon tissue.
  • PLLA microfilaments for mechanical strength at time zero and throughout the healing process. The PLLA has strength for up to 2 years before fully resorbing

• Reduced LOS (1 day)
• Lower post-operative pain scores
• Improved post-operative patient mobilization (sitting and walking)

• Patients in the 12mmHg AirSeal group developed SCE less often than patients in both the AirSeal 15mmHg and SI 15mmHg groups
• There was no difference in SCE rates between patients in AirSeal 15mmHg and SI 15mmHg groups
• Peak airway pressure was lower in both AirSeal groups VS. SI group
• etCO₂ was lower in the AirSeal 12mmHg group than both the AirSeal 15mmHg and SI 15mmHg groups

• Decreased occurrence of post-op ileus
• Shorter time to solid oral feeding

• A statistically significant difference in the mean operating time (110 minutes in the AirSeal group vs. 121 minutes in the Standard Insufflation group)
• Trend towards shorter LOS
• Trend towards lower post-op pain

• Significantly shorter (20.8%) Low Anterior Resection procedure times (232 min vs. 293 min)
• Significantly lower EBL (28.2%) in Low Anterior Resection procedures (150cc vs. 209cc)

• Each reduction in intraabdominal pressure corresponded to a significant decrease in initial pain scores and LOS
• Patients in the AirSeal 8 & 10mmHg groups had significantly shorter lengths of stay compared to the high-pressure groups (12 & 15mmHg)
• Each reduction in intraabdominal pressure corresponded to a significant decrease in Peak Inspiratory Pressures (PIP)
• Each reduction in intraabdominal pressure corresponded to a significant decrease in Tidal Volume (TV)

• Patient charges were significantly lower for patients that were discharged on the day of surgery with no increase in readmissions or emergency visits

• Patients had lower max pain scores between 5 and 12 hours
• Fewer overall complications
• The mean LOS was shorter (0.57 vs 1 day)
• 43.3% of patients were discharged on the day of surgery
• Fewer patients returned to the ER within 30 days
• Fewer patients were readmitted within 30 days

• Had a significantly shorter LOS
• Showed lower occurrence of post-operative ileus (decreased from 12% to 5%)

• AirSeal insufflation at 12mmHg was associated with a reduced risk of developing subcutaneous emphysema
• Pain was decreased in both AirSeal groups compared to standard insufflation

• Low stable pneumoperitoneum pressure with AirSeal in sickle cell disease (SCD) patients is associated with a significantly reduced incidence of post-operative SCD-related morbidity
• AirSeal allowed for rapid ambulation/return to regular diet without increasing the total cost per patient

• Were 7.81 times more likely to be discharged on the day of surgery
• Were 80.5% less likely to develop a new type of groin pain after surgery

• Central venous pressure and mean airway pressure showed improvements when AirSeal was used

• Lower inspiratory plateau pressure (Pplat)
• Lower minute volume (MV)
• Lower etCO₂
• Significantly higher static compliance (Cstat)

• Experienced both a lower incidence and severity of post-operative pain
• Had lower maximal peak airway pressure
• Had lower maximal etCO₂
• Had a lower maximal systolic blood pressure
• Twice as many patients in the AirSeal group were discharged on the day of surgery (46.7% vs. 23.3%)

• Patients in AirSeal + Exparel group had a shorter length of stay in hospital
• Procedures in AirSeal + Exparel group were 25% shorter in duration (101 minutes vs. 135 minutes)

• Procedures were 10.8% shorter in duration
• Warm ischemia time was 38.9% shorter
• A significant increase in the number of cases performed as “zero ischemia” (clampless) was observed in the AirSeal group (20 vs 4 cases)

• Had a pneumoperitoneum that was far more stable or less variable than patients in the Standard Insufflation group
• Had a lower etC0₂ after 10 minutes of insufflation than patients in the SI group

• Significantly less operative time (146min vs. 167min)
• Reduction in intraoperative blood loss (132ml vs. 215ml)
• Pain scores at 6-12 hours post-op were significantly lower (3.3 vs. 4.1) than the SI group

• With the AirSeal iFS, there was no disruptive loss of pneumoperitoneum, which saves time and allows the operator to focus without distraction
• The AirSeal iFS contributed to the successful completion of LTF in a 1.8kg infant

• Mean operative time decreased by 23.2 min in AirSeal group vs. SI group

• Patients in the AirSeal group had a LOS that was 34.7% shorter (19.6 vs 30 hours) than patients in the SI group

• Saved 12.3 minutes on average, which saves about $345 per case on OR time
• Had a mean EBL of 34.6cc compared to the VersaStep group which had a mean EBL of 45cc