Background: Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing. Purpose/hypothesis: The purpose of this study was to report the 12- and 24-month outcomes of patients who. Thursday, April 8, 2021. Courtesy of Miach Orthopaedics. Prior to the FDA approval, the BEAR implant was tested on pig models. A newly approved medical implant — Bridge-Enhanced® ACL Repair — is providing an alternate treatment for Anterior Cruciate Ligament tears. The current standard of care for ACL tears, which are among the most common. . Hammoud, Sommer MD 1,2. Author Information. 1 1Sidney Kimmel Medical College, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania. 2 Rothman Orthopaedic Institute, Philadelphia, Pennsylvania The BEAR ® (Bridge-Enhanced ACL Repair) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally-mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI
Key Takeaways. A new absorbable device known as the Bridge-Enhanced ACL Repair (BEAR) was approved by the Food and Drug Administration (FDA) to repair some anterior cruciate ligament (ACL) injuries. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knee's natural anatomy and function Knees treated with bridge-enhanced ACL repair had less macroscopic damage in the medial tibial plateau than those treated with ACLR or ACL transection (adjusted P = .03 for both comparisons). The knees treated with bridge-enhanced ACL repair had greater asymmetry in hindlimb maximum force and impulse loading at 52 weeks than the knees treated with ACL transection (adjusted P < .05 for both. The bridge-enhanced anterior cruciate ligament repair (BEAR) procedure: an early feasibility cohort study. Orthop J Sports Med. 2016;4(11). doi: 10.1177/2325967116672176. Proffen BL, Perrone GS, Roberts G, Murray MM. Bridge-enhanced ACL repair: a review of the science and the pathway through FDA investigational device approval Magnetic resonance imaging from the 9 patients in the bridge-enhanced anterior cruciate ligament repair (BEAR) group at 24 months shows intact anterior cruciate ligament (ACL) fibers from the femoral to tibial attachment sites (arrows). The intact fibers have low signal intensity (black), reflecting highly organized tissue with little free water 2.3. Suture Anchor Primary ACL Repair. Difelice et al. published in 2015 the results of an early follow-up of 11 consecutive cases treated with suture anchor primary repair (SAPR) of the ACL with a mean follow-up of 3.5 years .For the SAPR technique, the ruptured ACL was sutured starting at the intact distal end of the ligament and advanced in an alternating, locking Bunnell-type pattern up.
The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available. Bridge-enhanced ACL repair. The new technique is called the bridge-enhanced ACL repair (BEAR). Instead of replacing a torn ACL with a graft, the BEAR procedure bridges the torn ends of the ACL with a protein sponge that acts as scaffolding to encourage the ends of the ligament to grow back together This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.) Condition or disease
Bridge-enhanced repair of the ACL using collagen-platelet scaffolds has demonstrated promising biomechanical properties and a significant reduction in post-traumatic osteoarthritis in the large animal models. One next logical step, knowing these results, is to progress to a first in human trial for bridge-enhanced ACL repair The latest research of ACL reconstruction and repair with an emphasis on the bridge-enhanced ACL repair (BEAR) The anterior cruciate ligament (ACL) is an important stabilizer of the knee joint (1,2,3,4). It is an intracapsular structure that runs from the medial wall of the lateral femoral condyle to the anterior intercondylar area of the. Difference between ACL reconstruction and Bridge-Enhanced ACL Repair. A standard ACL reconstruction is actually two surgeries. First, the surgeon makes an incision in the patient's leg to harvest a tendon or ligament that will be used as a graft. Second, the surgeon removes the torn ACL and replaces it with the graft
Gregory S. DiFelice, MD, (New York, NY) demonstrates an anterior cruciate ligament (ACL) primary repair using his pioneering SwiveLock® anchor technique The U.S. Food and Drug Administration recently granted marketing authorization for an anterior cruciate ligament (ACL) implant, intended to perform as an alternative to traditional ACL reconstructions. The Bridge-Enhanced ACL Repair (BEAR) Implant, by Miach Orthopaedics, differs from the traditional surgical reconst.. One such method is Bridge-Enhanced ACL Repair (BEAR), where a suture repair of the ACL is supplemented with a bioactive scaffold. In preclinical trials, this technique has shown equivalent results to ACL reconstruction in terms of mechanical stability of the joint and knees treated with bridge-enhanced repair had significantly less. Bridge-Enhanced ACL Repair Tear and Repair In everyday life, the ACL normally performs well but starts punching above its weight when the knee is exposed to a twist or torque—from, say, landing a jump, skiing moguls or suffering a forward twisting fall
Bridge-Enhanced ACL Repair. The anterior cruciate ligament is one of four major ligaments in the knee joint. The anterior cruciate ligament (ACL) helps to function as one of the major stabilizers of the knee joint. Without an intact ACL, the knee joint may become unstable, and have a tendency to give out or buckle Miach Orthopaedics Inc. received approval Thursday from the U.S. Food and Drug Administration on its Bridge-Enhanced ACL Repair (BEAR) implant. It's the first medical technology clinically. Study Shows BEAR® Implant Achieves Similar Outcomes to Traditional ACL Reconstruction. LAS VEGAS - March 12, 2019 - Miach Orthopaedics, Inc., a privately held company dedicated to developing bio-engineered surgical implants for connective tissue repair, today announced study results showing that the Bridge-Enhanced® ACL Repair (BEAR®) procedure using the BEAR implant resulted in similar.
However, a new technique called a bridge-enhanced ACL repair (BEAR) is being studied in the United States and used in Europe. Summit Orthopedics' Dr. Jack Skendzel, an orthopedic surgeon specializing in ACL injuries, traveled to Germany in May of 2016 to learn more about repair—versus reconstruction—of ACL injuries Miach Orthopaedics plans to conduct a limited market release of the BEAR Implant in early 2021. About The BEAR® Implant Miach Orthopaedics' new Bridge-Enhanced® ACL Repair (BEAR®) Implant is a proprietary bio-engineered implant used to facilitate healing of the torn ACL. Unlike reconstruction, which is the current standard of care, the.
This study is designed to evaluate bridge-enhanced ACL repair (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. March 11, 2021 Last Verified: March 2021 Individual Participant Data (IPD) Sharing. Ligament Repair & Reconstruction. January 31st, 2021. The anterior cruciate ligament (ACL) continues to be the athlete's Achilles' heel. The ligament, once ruptured, leads to knee instability and, eventually, arthritis. The reconstructions return most people to sports—but not without a 50% incidence of arthritis after 10 years and a too. .We have tried the procedure in animal models and 10 patients. The goal of the current study is to determine if the new technique is as good as ACL reconstruction for a larger number of patients Bridge-Enhanced ACL Repair: From Concept to Clinical Trials Martha M. Murray, MD Professor of Orthopaedic Surgery Boston Children's Hospital Harvard Medical School DISCLOSURES I, Martha Murray, have relevant financial relationships to be discussed, directly or indirectly, referred to or illustrated wit
Bridge-Enhanced ACL Repair. The anterior cruciate ligament is one of four major ligaments in the knee joint. The anterior cruciate ligament (ACL) helps to function as one of the major stabilizers of the knee joint. Without an intact ACL, the knee joint may become unstable, and have a tendency to give out or buckle The Bridge-Enhanced ACL Repair (BEAR) Implant received approval under the De Novo premarket review pathway, the FDA regulatory pathway for low- to moderate-risk devices of a new type Fri, Jul 02, 2021. LOGIN Subscribe. Newsweek. he tore the anterior cruciate ligament in pigs have led to the first human trials of what she calls the Bridge-Enhanced ACL Repair (BEAR.
Routine ACL Surgery. Prior to the Bridge Enhanced ACL Repair technique other procedures to repair the ACL were tried but failed. Those procedures failed because the ACL could not be repaired to it's normal position and it didn't heal well enough to the femur. This produces a weak ACL repair which eventually failed The bridge-enhanced ACL repair (BEAR) could change the way we think about ACL injuries. Whereas a traditional reconstructions involves taking a graft from another part of the body and constructing.
Despite reported sex differences in ACL reconstruction outcomes [1, 9, 15, 17, 23, 41, 42, 44], no data exist on potential sexual dimorphism in outcomes of recently developed surgical treatments for ACL injuries such as bridge-enhanced ACL repair. In this study we examined the effect of sex on the biomechanical outcomes of bridge-enhanced ACL. The company's Bridge-Enhanced ACL Repair (BEAR) surgical implant is indicated for skeletally mature patients, ages 14 or older, with complete ACL ruptures confirmed by MRI. A surgeon secures the implant with sutures and injects the patient's own blood into it during the procedure with the intent of forming a device-protected clot that. Bridge-enhanced ACL repair allows doctors to use a sponge soaked with the patient's blood to repair a torn ACL rather than replacing it with a tendon from another part of the patient's body Anterior cruciate ligament reconstruction (ACL reconstruction) is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore its function after an injury. The torn ligament can either be removed from the knee (most common), or preserved (where the graft is passed inside the preserved ruptured native ligament) before reconstruction an arthroscopic.
Rehabilitation Protocol for ACL Reconstruction This protocol is intended to guide clinicians and patients through the post-operative course of an ACL reconstruction. Specific intervention should be based on the needs of the individual and should consider exam findings and clinical decision making This technique is called the Bridge-Enhanced ACL repair (BEAR), which utilizes sutures and a special platform to promote ACL healing. The scaffold/platform is a special protein-enriched sponge that is placed in between the torn ends of the ACL. This sponge is injected with the patient's own blood, allowing a clot to form to begin the healing. Miach Orthopedics expects to soon earn US FDA de novo clearance for its Bridge-Enhanced ACL Repair (BEAR) technology as an alternative to conventional anterior cruciate ligament reconstruction surgery. Trials have shown BEAR helps restore torn ACLs to normal strength and function
The company's initial focus is on the Bridge-Enhanced ACL Repair (BEAR) technology as a viable alternative to conventional ACL reconstruction for patients who have sustained an ACL injury. The BEAR technology was pioneered by Martha Murray, M.D., at the Boston Children's Hospital Department of Orthopaedic Surgery with initial research funding. I was also asked about Bridge enhanced ACL repair. Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific.. ACL Preservation, also known as PRESERVE ACL Repair Surgery, is a recently popularized surgical procedure wherein a patient's torn anterior cruciate ligament (ACL) is attached to the femur bone. This treatment makes it possible to treat about 30% of ACL injuries in instances where the ligament tears away from its natural attachment to the femur
BEAR (Bridge-Enhanced ACL Repair) Implan: Miach Orthopaedics, Inc. DEN200035: 12/16/2020: Gili Pro BioSensor (also known as Gili : ContinUse Biometrics Ltd. DEN200038: 04/01/2021: FilmArray Global Fever Panel: BioFire Defense, LLC: DEN200043: 11/20/2020: Neurolutions Upper Extremity Rehabilitat: Neurolutions, Inc. DEN200046: 04/23/2021 The primary goal of the study is to evaluate the outcomes of Bridge-Enhanced ACL Repair procedure versus the standard autograft patellar tendon reconstruction at six months, one year and two years after surgery. Researchers expect earlier improved range of motion and knee kinematics in the short-term and no graft harvest morbidity for the.
Bridge-Enhanced Anterior Cruciate Ligament Repair Leads to Greater Limb Asymmetry and Less Cartilage Damage Than Untreated ACL Transection or ACL Reconstruction in the Porcine Model March 01 2021. Bridge-Enhanced Anterior Cruciate Ligament Repair Leads to Greater Limb Asymmetry and Less Cartilage Damage Than Untreated ACL Transection or. Goals. Full Range Of Motion equal to uninvolved leg. Perform 4 inch step down. Bike with minimal resistance for 20-30 minutes (in saddle), walking for 30 minutes, Elliptical, water-walking
However, a new surgical option has just been authorized by FDA. On December 16th, FDA granted marketing authorization to Miach Orthopaedics, Inc. for the Bridge-Enhanced ACL Repair (BEAR) Implant, which does not require the use of harvested tendons for ACL repair and is the only currently-available alternative to ACL reconstruction Bridge-enhanced ACL repair, or BEAR, uses stiches and a bridging scaffold (a sponge injected with the patients' blood) to stimulate healing. The main differences between traditional ACL surgery and the BEAR technique are that the patient's grafts are not used in BEAR, and the remaining ACL tissue is preserved rather than removed Anterior cruciate ligament (ACL) surgical reconstruction techniques are evolving to improve short- and long-term outcomes for patients after surgery A newer approach that is getting a lot of attention is the bridge-enhanced anterior cruciate ligament repair (BEAR) Updated: 6/30/2021. ACL Tear. arthroscopic bridge-enhanced ACL repair (BEAR) trial with a bridging scaffold is ongoing. 2 year results show comparable results. ACL revision reconstruction. Anterior cruciate ligament rupture. 75% (4560/6101) 5. Torn discoid meniscus. 5% (318/6101) L This bridge-enhanced ACL repair technique resulted in equivalent mechanical outcomes of the repaired ACL and the reconstructed ACL at 15 weeks after surgery. 55 Other groups have replicated these results using a similar extracellular matrix based material in the goat model. 56 Additional in vitro work led to the finding that both.
The Bridge-Enhanced ACL Repair (BEAR) Implant is promoted as an alternative to reconstructive surgery using tendons from a patient's body or a tissue bank. This is very novel. It is a. For some authors, repair of the torn anterior cruciate ligament (ACL) in selected patients can be considered a valuable surgical treatment option. One of the main advantages is that it leaves all grafts available for any type of reconstruction in case the repair fails. This Technical Note describes arthroscopic ACL reconstruction after failure of an ACL repair Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75 mm to 5.5 mm SwiveLock anchor only). (K191226, June 11, 2019) Value Analysis Significance ACL primary repair with the SwiveLock ACL repair kit involves reattaching a torn ACL using SwiveLock anchors and high-strength FiberWire® and TigerWire® sutures
The Bridge-Enhanced ACL Repair (BEAR) surgery developed by Boston surgeon Dr Martha Murray uses a sponge bridge to connect the two ends of a torn native ACL. A special protein infused sponge-bridge is placed in between the two torn ends of the torn ligament, and the sponge is injected with the patient's own blood to create a clot and a. An ACL injury is one of the most common injuries suffered by athletes. ACL specialist, Dr. Matthew Provencher provides diagnosis and both surgical and nonsurgical treatment options for patients in Vail who have suffered an ACL injury. Contact Dr. Provencher's team today! Request Appointment. 970-479-5806 Its Bridge-Enhanced® ACL Repair (BEAR®) implant is a proprietary bio-engineered bridging scaffold to facilitate healing of the torn ACL. It is designed to be surgically placed between the torn ACL ends at the time of repair, and to physically hold a small amount of the patient's blood in the wound site. This provides a scaffold that allows. Background . Anterior cruciate ligament reconstruction (ACLR) is one of the most common lower extremity orthopedic surgeries performed in the United States. Annually, between 100,000 and 200,000 ACL tears affect 1 in 3,000 people. The selection of autograft versus allograft for ACLR has been widely discussed in terms of risk of graft failure Bridge-Enhanced Anterior Cruciate Ligament Repair Leads to Greater Limb Asymmetry and Less Cartilage Damage Than Untreated ACL Transection or ACL Reconstruction in the Porcine Model. The American Journal of Sports Medicine, 2021, pp. 363546521989265