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

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]

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

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.

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

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=.033)
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.
Downloads
Brochures
All references
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Data on file at Getinge.
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Cronwett & Johnston et al., Rutherford’s Vascular Surgery 8th ed., Vol 2, Elsevier, 2014.
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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.
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Feyrer, et al. Reduction of Neuropsychological Dysfunction after Cardiac Surgery with Heparin-coated Cardiopulmonary Bypass Circuits: Kardiotechnik 01/1998.
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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.
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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.
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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.