ArthroFLEX

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Instructions for Use
Product Specifications

ArthroFLEX®

ArthroFLEX®
ArthroFlex® is an acellular dermal matrix used to supplement soft tissue repairs such as the Achilles tendon and rotator cuff. It has ≥ 97% DNA removal, comes ready-to-use right out of the package, can be stored at room temperature (15°C - 30°C), and has a Sterility Assurance Level (SAL) of 10-6, which is equal to medical device-grade sterility.
  • Improved Clinical Outcomes: ArthroFlex demonstrated decreased re-tear rates and improved patient reported outcome scores after one and two years2,3
  • Increased Safety: Sterile with a SAL of 10-6 means lower risk of disease transmission
  • Decellularized: Uses Matracell® technology to remove ≥ 97% DNA and cellular remnants to decrease likelihood of immune response1,4
  • Promotes Rapid Healing: Biocompatible and retains natural growth factors, collagen and elastin1,4
  • Convenient: Preservon® technology allows graft to be stored fully hydrated at room temperature (15°C - 30°C) so it can be used right out of the package, without lengthy OR reconstitution processes1,4
  • Versatility: Available in multiple sizes and thicknesses
Clinical Application
  • Augment repairs of the rotator cuff
  • Augment repairs of the Achilles, biceps, quad and patellar tendons
  • Reinforce peroneal/tibialis tendons and flexor/extensor tendons of hand and foot
  • Reinforce capsular repairs
  • Suture reinforcement of soft tissue repairs
Order Code Description Sizing
AFLEX500 Decellularized Dermis Patch 0.5 x 30 x 40 mm
AFLEX400 Decellularized Dermis Patch 1.0 x 40 x 40 mm
AFLEX401 Decellularized Dermis Patch 1.0 x 40 x 70 mm
AFLEX100 Decellularized Dermis Patch 1.5 x 35 x 35 mm
AFLEX101 Decellularized Dermis Patch 1.5 x 40 x 70 mm
AFLEX103 Decellularized Dermis Patch 1.5 x 50 x 90 mm
AFLEX150 Decellularized Dermis Patch 1.5 x 15 x 140 mm
AFLEX200 Decellularized Dermis Patch 2.0 x 35 x 35 mm
AFLEX201 Decellularized Dermis Patch 2.0 x 40 x 70 mm
AFLEX202 Decellularized Dermis Patch 2.0 x 25 x 30 mm
AFLEX300 Decellularized Dermis Patch 3.0 x 40 x 50 mm
AFLEX301 Decellularized Dermis Patch 3.0 x 40 x 70 mm
AFLEX302 Decellularized Dermis Patch 3.0 x 50 x 60 mm
AFLEX822 (2 pack) Decellularized Dermis Patch 2.0 x 10 x 14 mm each
References
  1. Data on file at LifeNet Health TR-0272 to 65-0272
  2. Gilot GJ, Alvarez AM, Barcksdale L. Outcome of large to massive rotator cuff tears repaired with and without extracellular matrix augmentation: A prospective comparative study. Arthroscopy. 2015 Apr 17. pii: S0749-8063(15)00141-3.
  3. Denard PJ, Brady PC, Adams CR, Tokish JM, Burkhart SS. Preliminary Results of Arthroscopic Superior Capsule Reconstruction with Dermal Allograft. Arthroscopy. 2018;34(1):93-9.
  4. Moore MA, Samsell B, Wallis G, Triplett, S, Chen S, Linthurst Jones A, Quiz X. “Decellularization of Human Dermis Using Non-Denaturing Anionic Detergent and Endonuclease: A Review.” Journal of Cell and Tissue Banking