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Skicka

Fusion

Fusion Hybrid Vascular Grafts

Fusion

Vascular Grafts

Combining ePTFE with PET

Overview

The inner layer is comprised of ePTFE.[1] The outer layer is a knit polyester textile.[1] These two layers are fused together with a proprietary polycarbonate-urethane.

  • Smooth luminal surface of ePTFE[2]
  • Tissue ingrowth properties of PET[1]

Delivering benefits both during and post-procedure

  • Designed to provide minimal suture hole bleeding[1] for improved hemostasis
  • Axial compliance designed to reduce tension on the anastomosis[1]
Fusion Hybrid Vascular Grafts

Fusion-hybrid-needle-880x600.jpg

High suture retention strength[1]

Support Coil.jpg

Removable radiopaque continous support coil[1]

PERFECTION Trial Overview

The PERFECTION trial was a prospective, multi-center study designed to assess the clinical efficacy of the novel Fusion vascular graft.[3]

  • 117 patients underwent femoral-popliteal bypass with the Fusion vascular graft
  • Duplex ultrasound imaging and ankle-brachial indices were performed at 30 days, 6 months and 12 months
  • The primary efficacy end point was 12-month primary patency

Results

  • The 30-day primary graft patency was 95.3%
  • The 12-month primary rate was 85.6%, and the secondary patency rate was 93.2%
  • Ankle-brachial indices increased from a mean of 0.53 +/- 0.20 preoperatively to 0.97 +/- 0.16 at 30 days and 0.91 +/- 0.22 at 12 months

Patency rates equaled or exceed those reported with other nonbioactive vascular grafts and compare favorably with data from many studies of heparin-coated prostheses.

Conclusion
The PERFECTION trial concluded that the Fusion vascular graft is an effective alternative to ePTFE grafts and should be considered as an option in patients requiring femoral-popliteal arterial reconstruction.

Straight 

Diameter   Length Reference
5 mm 40 cm M002015010450
5 mm 80 cm M002015010850
6 mm 20 cm M002015010260
6 mm 40 cm M002015010460
6 mm 60 cm M002015010660
6 mm 80 cm M002015010860
7 mm 40 cm M002015010470
7 mm 80 cm M002015010870
8 mm 40 cm M002015010480
8 mm 60 cm M002015010680
8 mm 80 cm M002015010880
10 mm 40 cm M002015010410
10 mm 80 cm M002015010810

Helix supported 

Diameter   Length Reference
5 mm 40 cm M002015030450
5 mm 80 cm M002015030850
6 mm 40 cm M002015030460
6 mm 60 cm M002015030660
6 mm 80 cm M002015030860
7 mm 40 cm M002015030470
7 mm 80 cm M002015030870
8 mm 40 cm M002015030480
8 mm 60 cm M002015030680
8 mm 80 cm M002015030880
10 mm 40 cm M002015030410
10 mm 80 cm M002015030810

All grafts are fully supported except 3 cm on 1 end.

Alla referenser

  1. Data on file

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

  3. Assadian, A. and H.H. Eckstein, Outcome of the FUSION vascular graft for above-knee femoropopliteal bypass. J Vasc Surg, 2015. 61(3): p. 713-9.e1