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.
Combining ePTFE, PET and Heparin
The inner layer of Fusion Bioline is comprised of ePTFE. The Bioline heparin coating is bonded to this inner layer with albumin, the main blood protein found in human blood. The outer layer is a knit polyester textile. These two layers are fused together with a proprietary polycarbonate-urethane.
Getinge Bioline Coating
Bioline coating is composed of recombinant human albumin and heparin— a substance widely known as a safe and effective anti-thrombogenic., The Bioline process includes 3 layers of heparin and albumin on the graft which allows for a sustained effect. Albumin, acting in a complementary role of bonding agent and facilitator, is a contributor to Bioline’s exceptional performance., Covalent bonds between the heparin molecules and the albumin layer provide stability of the coating.
Time to hemostasis
Fusion Bioline Vascular Graft demonstrated significantly shorter time to hemostasis
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
- 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)
|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
|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.
Data on file at Getinge.
Cronwett & Johnston et al., Rutherford’s Vascular Surgery 8th ed., Vol 2, Elsevier, 2014.
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.
Feyrer, et al. Reduction of Neuropsychological Dysfunction after Cardiac Surgery with Heparin-coated Cardiopulmonary Bypass Circuits: Kardiotechnik 01/1998.
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.
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.
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.