BIOFIBER BIOFIBER CM AMBIENT TEMPERATUR. Absorbable Scaffold. Collagen Coated. Absorbable Scaffold

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1 BIOFIBER Absorbable Scaffold BIOFIBER CM Collagen Coated Absorbable Scaffold A B S O R B A B L E AMBIENT TEMPERATUR B I O L O G I C S C AAND F F OCRYOPRESERVE L D I N G S OSTORAGE L U T I O N S OPTION

2 What is BIOFIBER? An advancement in orthopedic absorbable polymers, BIOFIBER is the first orthopedic soft tissue scaffold that: Reinforces the suture-tendon interface Mechanically reinforces tendon repairs Designed for tissue in-growth utilizing an improved biocompatible polymer Made from P4HB A non-synthetic fermented polymer that breaks down into natural occurring metabolites Overlay Grommet support What is BIOFIBER - CM? Mid-substance reinforcement BIOFIBER - Collagen Matrix is comprised of the same P4HB material with the addition of a type 1 bovine collagen coating which increases vascularization and cell density at the site of repair. Provides long-term support while serving as a biocompatible scaffold for host tissue ingrowth Distributes tissue loads during the healing process while allowing for return of natural tendon attachment to bone Provides support during healing to permit return to normal joint mechanics Designed to provide support to damaged soft tissue to maintain structural integrity

3 BIOFIBER ABSORBABLE BIOLOGIC SCAFFOLD FOR SOFT TISSUE REPAIR AND REINFORCEMENT Why Reinforce? High failure rates for older patients or patients with thin, weak tendons High failure rates for larger tears Patients with comorbid conditions Suture line tears Tissue that forms post repair is mechanically weaker than native tissue Strengthen Repairs High tensile and suture retention strength Resorbable, biologically derived fiber Dense, bi-layer weave designed to provide mechanical properties in all directions Ability to wick and hold blood

4 BIOFIBER Applications BIOFIBER is available in multiple shapes and sizes which allows for a wide range of indications and repairs using a simple and fast surgical technique. Shoulder Rotator cuff repair Small tears Medium tears Subscapularis repair Foot/Ankle Achilles tendon repair Retrocalcaneal enthesiopathy Lateral ankle instability Knee Quadriceps tendon repair Patellar tendon repair BIOFIBER Reinforced Tendon: 73% Increase in Suture Retention vs. Control Suture Retention** Suture Retention Strength (N) Control BIOFIBER Average suture retention strength for BIOFIBER reinforced tendons was 110 N and the control tendons were 65 N which is an increase of 73 ± 37% (p < ) GRAFTJACKET MaxForce Extreme 216 BIOFIBER * 182 GRAFTJACKET MaxForce Data on file at Wright Barber, A. et al. Tendon augmentation grafts: biomechanical failure loads and failure patterns. Arthroscopy: The Journal of Arthroscopic and Related Surgery. 2006; 22-5: * BIOFIBER (3 cm x 3 cm) ** Mattress stitch 5 mm or more from an edge

General Information Material Poly-4-hydroxybutyrate (P4HB) Strength 216N*

12-18 months 10-6 SAL 2 years Engineered to internally reinforce the suture line

that breaks down to a natural occurring metabolite allowing healing without

designed to prevent fraying High strength yet elastic to share the load with

5 General Information Material Poly-4-hydroxybutyrate (P4HB) Strength 216N* Thickness Resorption Time Sterility Shelf Life Biomechanical Properties 1 mm months 10-6 SAL 2 years Engineered to internally reinforce the suture line and internally reinforce the tendon Biologic Properties Non-synthetic polymer that breaks down to a natural occurring metabolite allowing healing without inflammation * Mattress stitch 5mm or more from an edge Special leno weave designed to prevent fraying High strength yet elastic to share the load with in-growing tissue Edges ultrasonically cut for strength and consistency Porous design to encourage tissue in-growth

6 BIOFIBER Product Codes Product Item No. Description Discs: 8 mm each (2 discs/unit box) BFR Box of 1 BBF0008DU Box of 4 Strips: 13 mm x 23 mm (1 strip/unit box) BFR Box of 1 BBF1323SU Box of 4 BIOFIBER - CM Product Codes Product Item No. Description Strips: 20 mm x 30 mm (1 strip/unit box) BFR Box of 1 BIOFIBER Facility Reimbursement HCPCS Code Hospital Q4100 Skin substitute, not otherwise specified HCPCS Code Ambulatory Surgery Center L8699 Prosthetic implant, not otherwise specified 1023 Cherry Road Memphis, TN Nesbitt Avenue South Bloomington, MN and denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates Wright Medical Group N.V. or its affiliates. All Rights Reserved. CAW-5603 REV B ECN Jun-2016

TRELLIS COLLAGEN RIBBON

TRELLIS COLLAGEN RIBBON 147321-1 English (en) The following languages are included in this packet: M Wright Medical Technology, Inc. 5677 Airline Rd. Arlington, TN 38002 USA www.wmt.com August 2012 Printed