SwirlGraftTM:
FDA 510(k) and CE Mark approved for the following indications:
SwirlGraftTM Bypass Graft:
Arterial bypass and reconstruction. A thin-walled, helical ePTFE vascular prosthesis bearing an “easy-peel” PTFE support. Designed to offer improved graft patency by reduced outflow stenosis, even for low-flow indications.
| SwirlGraft™ Bypass Graft Specifications | |
|---|---|
| Relaxed Internal Diameter | 6.0 mm |
| Wall Thickness | >0.25 mm |
| Length | 70 cm |
| Balloon Burst Strength | > 1600 mmHg |
| Amplitude Ratio* | 0.5(±0.1) |
| Pitch** | 4.0 cm (±1.0 cm) |
* Amplitude Ratio = Amplitude (mm)/Relaxed Internal Diameter (mm)
** Pitch = Helical Wavelength
** Pitch = Helical Wavelength
SwirlGraftTM Vascular Access Graft:
Haemodialysis access. A medium-walled, helical ePTFE vascular access graft offering reduced kinking, ease of cannulation, and reduced thrombosis and outflow stenosis.
Clinical trials in the Netherlands have demonstrated significantly improved patency and performance compared to published results for conventional ePTFE vascular access grafts.
| SwirlGraft™ Vascular Access Graft Specifications | |
|---|---|
| Relaxed Internal Diameter | 6.0 mm |
| Wall Thickness | >0.47 mm |
| Length | 40 cm |
| Balloon Burst Strength | > 1600 mmHg |
| Burst Pressure after 24 Punctures | > 1600 mmHg |
| Amplitude Ratio* | 0.5(±0.1) |
| Pitch** | 7.0 cm (±1.0 cm) |
* Amplitude Ratio = Amplitude (mm)/Relaxed Internal Diameter (mm)
** Pitch = Helical Wavelength
** Pitch = Helical Wavelength
