You are visiting a website that is not intended for your region

The page or information you have requested is intended for an audience outside the United States. By continuing to browse you confirm that you are a non-US resident requesting access to this page or information.

Switch to the US site

Select Your Country or Region
Send
Kontakt

Fusion Bioline

Fusion Bioline

Fusion Bioline
Fusion Bioline

Fusion Bioline

Heparin Vascular Grafts

Dual-layer construction: ePTFE and PET layers. By adding the benefits of heparin to the unique Fusion dual-layer construction, the Fusion Bioline Graft sets a new standard for peripheral bypass treatment.

Spørgsmål? Spørg os om Fusion Bioline

Overblik

Fusion Bioline

Combining ePTFE, PET and Heparin

The inner layer of Fusion Bioline is comprised of ePTFE.[1] The Bioline
heparin coating is bonded to this inner layer with albumin, the main
blood protein found in human blood.[1] The outer layer is a knit polyester
textile.[1] These two layers are fused together with a proprietary
polycarbonate-urethane.[1]

  • Smooth luminal surface of PTFE [2]
  • Tissue ingrowth properties of PET [1]
  • Reduced time to hemostasis [1]
  • Reduced hemostatic agent usage [3]
  • Enhanced thromboresistance of heparin [3]

Delivering benefits during and after surgery

Enhancing Graft Performance [3], [4], [5]

  • Minimal suture hole bleeding for improved hemostasis[3]
  • Axial compliance designed to help reduce tension on the anastomosis[1],[2]
  • High suture retention strength and durability[1]
Bioline Coating

Getinge Bioline Coating

Bioline coating is composed of recombinant human albumin and heparin[1] —a substance widely known as a safe and effective antithrombogenic.[1],[6]  The Bioline process includes 3 layers of heparin and albumin on the graft which allows for a sustained effect.[1] Albumin, acting in a complimentary role of bonding agent and facilitator, is a contributor to Bioline’s exceptional performance.[3],[7] Covalent bonds between the heparin molecules and the albumin layer provide stability of the coating.[1]

Clinical Evidence

Fusion Bioline and the FINEST study

FINEST Trial Data - Patency

The Fusion Bioline graft was developed to improve the patency rate
associated with standard prosthetic grafts. The FINEST Trial was
designed to assess the clinical outcome of heparin-coated and standard
vascular grafts in a prospective, randomized, controlled, multicenter
trial.[3]

  • 209 patients
  • Prosthetic femoral to above-knee or below-knee popliteal bypass surgeries
  • Randomized to receive a standard ePTFE graft or the Fusion Bioline vascular graft
  • Grafts were assessed at 30 days, 6 months, and 12 months.

Read the study summary

FINEST Results 1

Time to homostasis

Fusion Bioline Vascular Graft demonstrated significantly shorter time to hemostasis[3]

Suture-hole bleeding times were significantly shorter with Fusion Bioline (P=<0.0001); observed mean times to hemostasis were 3.5 minutes for Fusion Bioline Vascular Graft vs. 11.0 minutes for the Standard ePTFE graft

FINEST Results 2

Use of hemostatic agent

Conclusions

  • Fusion Bioline Heparin Coated Vascular Graft demonstrated higher primary patency rates at 12 months as compared to Standard ePTFE in a prospective randomized controlled trial
  • Fusion Bioline Heparin Coated Vascular Graft demonstrated significantly shorter time to hemostasis as compared to Standard ePTFE
  • The percentage of subjects with any MALE (Major Adverse Limb Event) and POD (Periprocedural Death) was significantly higher in the Standard ePTFE group than in the Fusion Bioline group. MALE/POD occurred in 30.7% and 17.1% respectively for the Standard ePTFE and Fusion Bioline groups at 12 Months (P=0.033)

Product Information

Straight  

Diameter   Length
5 mm 40 cm
5 mm 80 cm
6 mm 20 cm
6 mm 40 cm
6 mm 60 cm
6 mm 80 cm
7 mm 40 cm
7 mm 80 cm
8 mm 40 cm
8 mm 60 cm
8 mm 80 cm
10 mm 40 cm
10 mm 80 cm

Helix Supported    

Diameter   Length
5 mm 40 cm
5 mm 80 cm
6 mm 40 cm
6 mm 60 cm
6 mm 80 cm
7 mm 40 cm
7 mm 80 cm
8 mm 40 cm
8 mm 60 cm
8 mm 80 cm
10 mm 40 cm
10 mm 80 cm

All grafts are fully supported except 3 cm on one end.

Downloads

Brochure

Relaterede produkter

Fusion Hybrid Vascular Grafts

Fusion

Combining ePTFE with PET

Find ud af mere

Intergard Heparin Knitted

Intergard Heparin Knitted

Proprietary heparin-bonding process designed to allow the antithrombotic and antiproliferative properties of biologically active heparin to be available locally at the graft surface.

Find ud af mere

Graft Sizers

Graft Sizers

Single use graft sizers are designed to aid the physician in determining the size of the lumen of the host vessel in order to select the appropriate graft diameter.

Find ud af mere

Alle referencer

  1. Data on file at Getinge.

  2. Cronwett & Johnston et al., Rutherford’s Vascular Surgery 8th ed., Vol 2, Elsevier, 2014.

  3. Lumsden et al., Randomized controlled trial comparing the safety and efficacy between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE (FINEST) Trial., Journal of Vascular Surgery Mar 2015.

  4. Feyrer, et al. Reduction of Neuropsychological Dysfunction after Cardiac Surgery with Heparin-coated Cardiopulmonary Bypass Circuits: Kardiotechnik 01/1998.

  5. Palatianos GM, Foroulis CN, Vassili MI. et al. A prospective, double-blind study on the efficacy of the bioline surface-heparinized extracorporeal perfusion circuit; Ann Thoracic Surg 2003 Jul;76(1):129-35.

  6. Dietrich Bosse 1 , Michaela Praus, Peter Kiessling, Lars Nyman, Corina Andresen, Joanne Waters, Fritz Schindel. Phase I Comparability of Recombinant Human Albumin and Human Serum Albumin. J Clin Pharmacol. 2005 Jan;45(1):57-67. doi: 10.1177/0091270004269646.

  7. MANSOOR AMIJI and KINAM PARK, Surface modification of polymeric biomaterials with poly(ethylene oxide), albumin, and heparin for reduced thrombogenicity., Journal of Surface Modification of Biomaterials, 1992, Aug.

Abonnement