Ed Boarini, Sr. Vice President Teleflex Medical OEM

1. Suture and Fiber Material Selections
for Cardiovascular Device Components
Ed Boarini, Sr. Vice President of OEM Strategy and Business Development
Teleflex Medical OEM

2. Global Leader in Custom-Engineered Sutures,
Performance Fibers, Extrusions, and Catheters
2
TFX OEM®
• Extrusions
• Diagnostic and Interventional
Catheters
• Sheath/Dilator Sets (Introducers)
and Kits
DEKNATEL®
• Sutures
• Performance Fibers
• Bioresorbable Yarns and Resins

3. Deknatel: A History of Fiber Expertise
• Founded by John Deknatel, a Dutch
immigrant, during the 1890s in Brooklyn, NY
• Remained a family business throughout the
first part of 20th century
1800’s
• Coventry, CT plant acquired
1950’s
• Deknatel expanded into medial devices
such as the Pleur Evac® System for chest
drainage
1960’s

4. Deknatel: A History of Fiber Expertise
• Deknatel purchased by Pfizer in 19751970’s
• Deknatel‟s NY operation relocated to Fall
River, MA
1980’s
• During 1993, Pfizer spun off their suture business and Deknatel, Inc.
was established
• In 1995, Deknatel, Inc. merged with Snowden Pencer, which later
became part of Genzyme Biosurgery in 1996
1990’s
• Deknatel acquired by Teleflex, Inc.
• Mansfield, MA facility established during 2005
2000’s

5. Classification of Sutures and Components
Material Composition
• Natural
• Synthetic
Behavior in Tissue
• Absorbable
• Permanent
Physical Structure
• Monofilament
• Multifilament/Braid

6. Resin is Only the Beginning – Physical Structure
Resin
Monofilaments Multifilament
Assembled
into a Medical
Device or
component
Coreless Core

7. Monofilament Versus Multifilament
ADVANTAGESDISADVANTAGES Monofilament
Less tissue drag
No capillary action
Has memory, wiriness
Knots more difficult,
requires more throws
Multifilament (Braided)
More pliable, flexible (better handling)
Better knot security
Less throws required
Has capillary action, braided
less than twisted
Rougher surface can cause
tissue drag (lubricity and coatings
make a difference)

8. Core Versus Coreless
Core
• Larger knot profile
• Requires more knot
throws
• Rounder shape
Coreless*
• Low knot profile
• Lies flat
• Better knot security
*Canadian Patent Application No. 2,509,871
Title: High-Strength Suture
Applicant: Teleflex Medical Incorporated
*US Patent No. 8,088,146
Title: High-Strength Suture
Applicant: Teleflex Medical Incorporated
Publication Date: April 26, 2012.

9. Selecting the Best Material for Your Application
Filament, Suture, or Construct
Absorbable Permanent
Performance Criteria
Strength Flexibility
Knot Security Size
Capillarity Surface
Characteristics

10. Absorbable Versus Permanent
Absorbable
• Bondek® Plus (PGA)
• PLLA
• PGLA, PLGA
• Monodek® (PDO)
Permanent
• Force Fiber ® (UHMWPE)
• Cottony® II (Polyester)
• Polydek ® and Tevdek®
(PTFE-coated Polyester)
• Deklene® II
(Polypropylene)
• Nylon
• Silk

11. Performance Characteristics Important
to Your Application
• Size
• Flexibility
• Surface
Characteristic
• Capillarity
• Strength
• Knot Security

12. Performance Characteristics
Multifilament Size
DENIER or DEN
is a Unit of Measure
for the Linear Mass Density
of Fibers
It is defined as the mass in grams
per 9,000 meters.
(A 9,000-meter strand of silk weighs
about one gram.)
TEX or DTEX
is a Unit of Measure
for the Linear Mass
Density of Fibers
It is defined as the mass in grams per
1000 meters.
TEX is more likely to be used
in Canada and Continental Europe,
while DENIER remains more
common in the United States and
United Kingdom.
When measuring objects that consist
of multiple fibers the term "filament
tex" is sometimes used, referring to
the mass in grams per 1000 meters
of a single filament.

13. Performance Characteristics
Suture Sizing of Monofilaments and Multifilaments
USP Refers to Suture Sizes Defined by the United States
Pharmacopeia (U.S.P.)
Sutures range from #5 (heavy braided suture for orthopedics) to #11-0
(fine monofilament suture for ophthalmics).
Atraumatic needles are manufactured in all shapes for most sizes.
The actual diameter of braid for a given U.S.P. size differs depending
on the suture material class.
Profile of multifilaments, based on strength, will vary depending on materials.
Profile Reduction at Same Strength
Polypropylene PTFE Nylon Polyester Steel UHMWPE

14. Performance Characteristics
Flexibility
This performance characteristic is determined by the torsional
stiffness and diameter, which influences handling and feel.
Multifilament
• More pliable, flexible – better
handling
Monofilament
• Has memory
• Wiriness in handling

15. Performance Characteristics
Surface Characteristics
The surface of the suture influences the ease of pull through tissues
(friction or drag) and the amount of irritation.
• Monofilament versus multifilament
• Coatings
ADVANTAGESDISADVANTAGES
Monofilament
Less tissue drag
Knots more difficult,
requires more throws
Multifilament (Braided)
Better knot security
Less throws required
Rougher surface can cause
tissue drag (lubricity and coatings
make a difference)
• Lubricity of material
• Abrasion-resistance

16. Performance Characteristics
Capillarity
This is the process where fluids are carried into the interstices
of multifilament fibers. Coating can reduce the capillarity of some sutures.
Monofilament
• No capillary action
Multifilament
• Has capillary action
• Braided has less
capillary action than
twisted
• Coating can reduce
capillarity

17. Performance Characteristics
Strength
Absorbable
• Strength will degrade over time as it
resorbs in body
Permanent
• Strength remains stable over time
• Knot tensile strength is the force the braid can withstand before the
knot breaks.
• The degradation profile of absorbable filaments and the tensile
strength curve over that degradation

18. Performance Characteristics
Knot Security
Knot holding capability is the strength required to untie
or break a knot of the suture that forms the loop.
Monofilament
• Knots more difficult
• More throws required
Multifilament
• Better knot security
• Less throws required

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Selected Applications

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Selected Orthopedic Applications
Rotator Cuff Repair
• Procedure to fix a torn tendon in the shoulder
• Performed as either “open” or “closed” arthroscopic
repair
• The rotator cuff helps to lift and rotate the arm
and stabilize the ball of the shoulder within the joint
Glenoid Repair
• Glenoid: shoulder socket
• Glenoid labrum (fibrous ring that deepens the
concavity of the shoulder socket) and surrounding
ligaments can be torn when the arm
is forced backwards. Failure to repair can lead
to shoulder dislocation.
Important Properties for These Procedures
• Strong tensile strength
• Surface characteristic: lubricity – easy to glide through tissue
• Low knot profile – coreless design is ideal

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Selected Cardiovascular Applications
AAA / TAA repair
• Aortic aneurysm (a bulging, weakened area in the wall of the aorta) resulting
in abnormal widening greater than 50%
• Surgery is used to prevent rupture of the aneurysm. Grafts (such as those
made from PTFE) are also used here.
• Surgery can be “open” or minimally invasive (EVAR)
– Small incision in groin, stent graft inserted in femoral artery and
advanced up into the aorta to the site of the aneurysm.
Heart Valve Replacement
• Intervention or surgery to replace or repair diseased heart valves.
Important Properties for These Procedures
• Smallest size
• Surface characteristic: lubricity – easy to glide through tissue
• Low knot profile
• Strong tensile strength

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Force Fiber® is a Key Product
for These Applications
• Smooth surface and custom braid design allows
for lubricious pass through
– Silky feel assures that tissue damage is minimized
and surgeon‟s hand‟s are spared.
– Nothing has been “added” to the fibers to make them
lubricious so FDA clearance for device is that much
easier.
• Flatter design allows for lower knot profile
and superior knot stability
– Less irritation for patient if knots below the surface
have a lower profile.
– Once set, knots stay in place and maintain strength
and stability for the long haul.
• Color options
– Co-Braids - color traces allow for quicker and easier
suture identification as well as motion detection.
– Critical for complex multi-suture surgeries.

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Customized Solutions for Performance Fibers
• EXTENSIVE IN-HOUSE CAPABILITIES separate us
from the competition.
– Component braid/monofilament: Spooled, sterile, or NS
off the shelf items, set spool lengths
– Bulk suture: Spooled, NS off the shelf items, set spool lengths
– Cut lengths: Sterile or NS, some are standard, tipping available
– Devices/ finished goods Private label, sterile finished goods
– Assembly: Components from other sources assembled
and packaged
– Resins and fibers: PGA / PLLA / Polyesters
• Industry-leading, CUSTOMER-FOCUSED SERVICES
– Engineering and technical sales to support product development
– Project teams that act as a „second arm” to our customers‟ teams
– Regulatory support
– Sourcing options: we can manage customer identified/specified
components
– Sterilization: we can offer fully validated sterilization and
packaging scenarios

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In Summary: Basic Sutures, Filaments, and Structures
• Available in bulk or as finished sterile
product.
• Filaments can be processed as
components of customer‟s finished
devices, such as slings, meshes, and felts.
Wovens and knitted products are available
through strategic partnerships.
• Wide range of services available to our
customers including private labeling and
regulatory filings.
Sutures
• Absorbable
• Non-absorbable
• Coated and Uncoated
• Braided and Monofilament
Filaments
• Absorbable
• Non-absorbable
Configured Products
• Absorbable
• Non-Absorbable
• Needled
• Assemblies

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Visit www.teleflexmedicaloem.com
©2013 Teleflex Incorporated. All rights reserved. Deknatel, Force Fiber, Bondek Plus, Monodek,
Cottony, Polydek, Tevdek, and Deklene are registered trademarks of Teleflex Incorporated. This
presentation should not be reproduced in part or whole without the permission of Teleflex Incorporated.