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Fusion Bioline

Fusion Bioline
Fusion Bioline Procedure
Fusion Bioline with sutures
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.

Overview

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]
Doctors in operating environment

Delivering benefits during and after surgery

  • 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 anti-thrombogenic.[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 complementary 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 on PubMed

FINEST Results 1

Time to hemostasis

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=.03​3)

Product Information

Straight  

Diameter   Length Reference
5 mm 40 cm M00201501045B0
5 mm 80 cm M00201501085B0
6 mm 20 cm M00201501026B0
6 mm 40 cm M00201501046B0
6 mm 60 cm M00201501066B0
6 mm 80 cm M00201501086B0
7 mm 40 cm M00201501047B0
7 mm 80 cm M00201501087B0
8 mm 40 cm M00201501048B0
8 mm 60 cm M00201501068B0
8 mm 80 cm M00201501088B0
10 mm 40 cm M00201501041B0
10 mm 80 cm M00201501081B0

Straight Externally Supported   

Diameter   Length Reference
5 mm 40 cm M00201503045B0
5 mm 80 cm M00201503085B0
6 mm 40 cm M00201503046B0
6 mm 60 cm M00201503066B0
6 mm 80 cm M00201503086B0
7 mm 40 cm M00201503047B0
7 mm 80 cm M00201503087B0
8 mm 40 cm M00201503048B0
8 mm 60 cm M00201503068B0
8 mm 80 cm M00201503088B0
10 mm 40 cm M00201503041B0
10 mm 80 cm M00201503081B0

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

All references

  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.