Omniflow II biosynthetic vascular prosthesis - Adef-Rio

Omniflow II biosynthetic
vascular prosthesis
A unique solution to challenging
clinical situations
BN 9-12(0)-1

Designed to resemble autologous vein
• Haemocompatible
– Smooth, non-thrombogenic
flow surface
– Good long-term patency,
even with poor runoff
• Non-porous
– No seeping or
seroma formation
– No needle-hole bleeding
– No tissue ingrowth
• Biocompatible
– Rapidly integrated into
host tissue
– Good resistance to
infection
– Rapid haemostasis after
puncturing
• Good compliance
– Little intimal hyperplasia
– Can be anastomosed
directly to peripheral blood
vessels
– No need for cuffs, patches
or jump grafts
BN 9-12(0)-1

The Biosynthetic Solution
• Smooth
• Non-thrombogenic
• Non-porous
• Crosslinked
ovine collagen
• Reinforcing polyester
mesh
BN 9-12(0)-1

Rapid integration into host tissue
No visible difference between
graft and host tissue
Weeks to
months
Original
graft
Rugged exterior
facilitates tissue
integration
BN 9-12(0)-1
Micro-vascularisation of the
graft wall contributes to
resistance against infections
Host
tissue
Omniflow II explanted after 7 years as
fempop bypass graft (Bio Nova
International, data on file)

Omniflow II
Non-porous and biocompatible
Highly biocompatible
PTFE
Porous and bio-inert
Omniflow
maintains the
integrity of its
smooth lumen
PTFE displays tissue
ingrowth into the
lumen
Omniflow is
biocompatible and
well integrated in
surrounding tissue
Thrombus
formation
PTFE is bio-inert
and poorly
integrated in
surrounding
tissue
Data from an experimental dog after 13
months (Ketharanathan & Christie
Aust NZ J Surg 1981; 51:556-561)
BN 9-12(0)-1

Ease of Handling
Handles like a saphenous vein
Thin and supple
Cut, trimmed and shaped with
ease
Easy to suture
Excellent suture retention
Minimal suture-hole bleeding
with standard sutures
Can be anastomosed directly
to peripheral vessels
No need for cuffs, patches or
jump grafts
Ideal for AV access
Straight or curved configuration
Preformed loop prevents kinking
Easy to puncture
Rapid maturation
Rapid haemostasis after puncturing
Responds well to revision
BN 9-12(0)-1

The Clinical Solution
• Peripheral revascularisation
– Good long-term patency
• Particularly suitable below the knee
• Even with poor runoff
– Good resistance to infections
• Arteriovenous access
– High primary and secondary patency
– Good resistance to infections
– Early puncturing and rapid haemostasis
• Vascular repair/patching
– Good patency
– Resistant to infection
– Easy suturing
BN 9-12(0)-1

Peripheral revascularisation
First choice when no saphenous vein available
Patency for below-knee
bypass significantly better
than PTFE
Primary patency for below-knee bypass
Good long-term patency up
to eight years recorded
Secondary patency rates for Omniflow II
Koch et al. Zentralbl. Chir. 1996;
121: 761-767.
Nakajima et al. Jpn J Vasc Surg 1996; 5: 801-807.
Milne P. Personal communication.
Field P. Data on file, Bio Nova International
BN 9-12(0)-1

Arteriovenous access
First choice when autologous fistula cannot be made
Patency not significantly
different from AVF
Secondary patency of AV access grafts
Excellent patency rates in
recent study
Patency rates for Omniflow II in AV access
Enzler et al. Clin Transplant 1996;
10: 511-515
Palumbo et al. Abstract presented at the Renal week of the
American Society of Nephrology, San Diego, CA 14-19/11/2006.
BN 9-12(0)-1

Reduced risk of infection
First choice for patients susceptible to infection
• Smooth flow surface
prevents bacterial invasion
Femoropopliteal bypass
Arteriovenous access
• Graft revascularisation
facilitates immune response
and antibiotic therapy
• Clinical data demonstrates
superiority to synthetic
prostheses
Koch G et al. Zentralbl Chir
1996; 121: 761-767
Enzler et al. Clin Transplant
1996; 10: 511-515
BN 9-12(0)-1

Biosynthetic solution overcomes issues
Autologous
fistula or saphenous
vein
Other autologous vessel(s)
• Deep veins
• Arm veins
• Radial artery
Homologous vein
• Cryopreserved
• Transplanted
Biological prostheses
• Cadaveric xenografts
• Human umbilical vein
Synthetic prostheses
• PTFE
• Dacron
• Polyurethane
Issues
Operating time
Graft performance
Co-morbidity
Patient QOL
Product cost
Availability
Immunosuppression
Durability
Traceability
Cost, supply
Patency
Infections
Handling
Biosynthetic prosthesis
• Ovine collagen with integral polyester mesh
• Combines biological and synthetic properties
• Good long-term patency
• Resistance to infection and aneurysm formation
• Excellent handling properties
• Available off the shelf
• More than 25 years of clinical experience
BN 9-12(0)-1

BN 9-12(0)-1
For Sustained Performance