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FlexBand Solo
Following an injury, surgical repair of the ligaments and tendons can fail to restore nature’s balance of strength and elasticity. This imbalance can lead to long recovery times, ongoing pain, loss of function, and long-term issues such as arthritis and deformity.
Artelon’s FLEXBAND® is a next-generation biomaterial specifically designed to help restore natural strength and elasticity to healing soft tissues—with the goal of getting people back to natural motion, faster and stronger.
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Artelon
Artelon
The original vision for Artelon was cast by world renown orthopedic surgeon Lars Peterson, MD/PhD. His experience clinically investigating multiple synthetic tendon and ligament devices that failed highlighted key design features necessary for a synthetic material to demonstrate real-world success in ligament and tendon reconstruction. Working with an elite team of chemists and textile engineers, Dr. Peterson’s vision came to fruition in the form of Artelon’s Dynamic Matrix. Since its inception, this technology has delivered on its promise of enhanced biological and mechanical soft tissue reconstruction with over 60,000 implantations worldwide.
Today Artelon is headquartered in Marietta, GA, and remains committed to innovations focused on restoring joint stability and kinematics through novel ligament and tendon products and procedures.
Our various FLEXBAND Solo, Multi, and FIX Kit Systems offer complete sets of tools and implants in a single-use, sterile blister targeting specific indications. An Artelon Sales Agent can work with you to determine which kit and accessories are most appropriate for your upcoming procedure.
The fibers of FLEXBAND are made from the combination of two polymers common to medical devices – polycaprolactone and polyurethane-urea. This patented co-polymer was designed for specific characteristics of strength, elasticity, and biological integration.
Surgical repair of torn ankle tissue reconnects the injured structures and reestablishes biological healing. However, these tissues are often in poor condition and repair can only do so much. Studies have shown suture repair alone may restore less than 50% of the tissue's original strength.
The FLEXBAND biomaterial has a strength similar to ankle ligaments, providing a dramatic increase in construct strength when added to the primary repair. One study demonstrated the repair strength to DOUBLE when our Dynamic Matrix® augmented the repair.
As your foot moves, the ligaments and tendons of your ankle stretch and contract under tension to permit motion while maintaining stability. Therefore, biomaterials intended to augment the strength of this tissue also need to stretch and contract under tension. Artelon’s FLEXBAND was uniquely designed to do just that. Our novel material stretches and rebounds throughout the motion of the ankle.
If supported, nature is a fantastic healer. FLEXBAND was purposely engineered to work with nature throughout the healing process. Our material exists quietly in the body, quickly integrating into healing tissue in the short term. Over the longer term, FLEXBAND slowly dissolves while being replaced by healthy new tissue in a process that takes 4-6 years. This process of integration and replacement aligns enhanced strength, elasticity for motion, and the biological restoration of the tissue to optimize recovery in both the short and long term.
FlexBand®, FlexPatch®, and FlexBand Plus® are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.
FlexBand®, FlexPatch®, and FlexBand Plus® are also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.
FlexBand®, FlexPatch®, and FlexBand Plus® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the tendon repair. The products reinforce soft tissue and provides a degradable scaffold that is incorporated into the patient’s own tissue.
(510k Clearances K230316 and K200503)
