DYNAMIC

Stability

AND

BIOLOGICAL

Restoration

Following an injury, surgical repair of the soft tissues 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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What is it?

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 Connective Tissue

These fibers are then knitted into a Dynamic Matrix® with pores specifically sized for connective tissue cells.

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How Does FLEXBAND Work?

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Elasticity to Optimize Motion

As your foot moves, the soft tissues 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 soft tissue, 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.

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

FLEXBAND Indications for use:

Artelon® FlexBand, FlexPatch, and FlexBand Plus Tissue Reinforcement products are intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Artelon® FlexBand, FlexPatch, and FlexBand Plus are also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Artelon® FlexBand, FlexPatch, and FlexBand Plus are not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

(510k Clearances K191221 and K071887)

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