BIOFIBER
™
Absorbable Biologic Scaffolding Solutions
BIOFIBER™ IS ONLY THE BEGINNING
BIOFIBER - CM
™
What is BIOFIBER™ – CM?
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 in-growth
• 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
Reinforces the
suture-tendon interface
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 tendons repairs
• Made from P4HB – A non-synthetic fermented polymer
that breaks down into natural occurring metabolites
that allow healing without additional inflammation
• Increases suture line load sharing
• Creates a cell friendly environment for rapid
incorporation of soft tissue
Humeral Bone
BIOFIBER™ is woven out of a high-strength, biologically
derived material that resorbs over time.
Tendon
• Designed for tissue in-growth utilizing an improved
biocompatible polymer
• Creates a cell-friendly environment for rapid incorporation of
soft tissue with full scaffold resorption at 12-18 months
BIOFIBER™
Tendon
Tendon in-growth within scaffold
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
Why Reinforce?
•H
igh 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
Suture Retention**
Suture Retention Strength (N)
BioFiber Reinforced Tendon:
73% Increase in Suture Retention vs. Control
120
300
100
250
110.0
80
216
182
100
65.1
50
20
0
229
150
60
40
200
Control
BIOFIBER™
A verage 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 < 0.0001)
0
GraftJacket™
MaxForce Extreme
BIOFIBER™*
GraftJacket
MaxForce
Data on file at Tornier, Inc.
Barber, A. et al. Tendon augmentation grafts: biomechanical failure loads and failure patterns.
Arthroscopy: The Journal of Arthroscopic and Related Surgery. 2006; 22-5: 534-538.
* BIOFIBER™ (3 cm x 3 cm)
**Mattress stitch 5 mm 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
Biomechanical Reinforcement
Overlay
Grommet support
Mid-substance reinforcement
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
Foot/Ankle
Knee
Hip
• Rotator cuff repair
• Small tears
• Medium tears
• Subscapularis repair
• Achilles tendon repair
• Retrocalcaneal enthesiopathy
• Lateral ankle instability
• Quadriceps tendon repair
• Patellar tendon repair
• Hip abductor tendon repair
BIOFIBER™ Product Codes
BIOFIBER™ Facility Reimbursement
Product Item No. HCPCS Code – Hospital
Product Description
Discs: 8 mm each (2 discs/unit box)
BFR100101
Box of 1
BBF0008DU
Box of 4
Q4100 Skin substitute, not otherwise specified
HCPCS Code – Ambulatory Surgery Center
L8699 Prosthetic implant, not otherwise specified
Strips: 13 mm x 23 mm (1 strip/unit box)
BFR100201
Box of 1
BBF1323SU
Box of 4
Strips: 20 mm x 30 mm (1 strip/unit box)
BFR100301
Box of 1
Strips: 25 mm x 50 mm (1 strip/unit box)
BFR100401
Box of 1
BIOFIBER™ - CM Product Codes
Product Item No. Product Description
Strips: 20 mm x 30 mm (1 strip/unit box)
BFR100302
Box of 1
Indications:
• Temporary wound support required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the
addition of a reinforcing material to obtain the desired surgical result.
•R
einforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator
cuff, patellar, achilles, biceps and quadriceps tendons.
•B
ioFiber is intended for single patient, one time use only
• BioFiber is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support structures.
Contraindications: A complete list of contraindications can be found in the “instructions for use“ packaged with the implants.
1023 Cherry Road
Memphis, TN 38117
800 238 7117
901 867 9971
www.wright.com
10801 Nesbitt Avenue South
Bloomington, MN 55437
888 867 6437
952 426 7600
www.tornier-us.com
BIOFIBER™ is a trademark or registered trademark of Tornier in the U. S. and other countries.
™Trademarks and ®Registered marks of Wright Medical Technology, Inc.
©2016 Wright Medical Technology, Inc. All Rights Reserved. CAW-5601 Rev B ECN 160069 11-Jan-2016