DYNAMIC
Stability
AND
BIOLOGICAL
Restoration
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.
It is a Co-Polymer
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.
It is a Textile for Ligaments and tendons
These fibers are then knitted into a Dynamic Matrix® with pores specifically sized for connective tissue cells.
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Elasticity to Optimize Motion
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.
Integration with Biology
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.
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Enhanced Strength to Optimize Recovery
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.
What is it?
How Does FLEXBAND Work?
FLEXBAND augmenting a soft
tissue repair in the ankle
Live cells on FLEXBAND at 9 Days
FLEXBAND integrated into an ankle soft tissue at 6 months
Product Configurations
FLEXBAND Systems
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.
Dynamic Matrix Products
FLEXBAND Plus is our premium FLEXBAND Matrix product line, and is available in three different widths and multiple lengths. Adding greater value and efficiency to the OR, these FLEXBANDS have integrated size 0 braided polyblend non-absorbable whip-stitching to facilitate quick matrix passing and fixation.
The FLEXBAND is 1.2 mm thick and is commonly utilized in the repair and reconstruction of soft tissues throughout the extremities.
The FLEXPATCH is roughly half the thickness of the FlexBand (0.7 mm) and is favored when broad dynamic augmentation is needed.
FLEXBAND Indications for use:
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
1. Gisselfalt, K et al. Biomacromolecules. 2002 3: 951-958
2. Waldrop et al. AM J Sports Med. 2012 Nov; 40(11): 2590-6
3. Data on File. TR-061 Artelon Tissue Reinforcement Implant Tensile Testing
4. Gersoff et al. J Knee Surg. 2019 32(5):434-440
5. Liljensten et al. J Mater Sci Mater Med. 2002 Apr; 13(4): 351-9