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Read more about Omniflow®II's
Limb salvage
Omniflow® has demonstrated high limb-salvage rates. One study covering 191 patients with severe ischemia (80% Fontaine stage III-IV, remaining 20% stage IIb with walking distance <50m) reported a limb salvage rate of 85% after 1 year and 66% after 3 years [Raithel, 1989].
Another study evaluating 274 implanted Omniflow® in above-knee, below-knee and femorocrural bypass reported limb-salvage rates of 81%, 71% and 60%, respectively, after three years. All the operated patients has Fontaine stage III or IV disease (rest pain or gangrene) and ankle pressure <50mmHg [Koch et al., 1997].
In a randomised study the limb salvage capability of Omniflow® outperformed PTFE. Omniflow® displayed a limb salvage rate for below-knee femoropopliteal bypass of 71% after 3 years vs. 54% for PTFE [Koch et al., 1996].
Resistance to Infection
Omniflow® has demonstrated high resistance to infection, both in peripheral bypass and AV access applications. This is believed to be partly due to the good biocompatibility leading to integration of Omniflow® in the host tissue and microvascularisation of the Omniflow® vessel wall [Ramshaw et al., 1995].
Omniflow® has demonstrated a very low rate of graft infections in bypass operations. Several trials have demonstrated nil or very low rate of graft infections in Omniflow®. One study reported no infections in 270 Omniflow® prostheses implanted over 7 years [Koch et al., 1996]; the rate for PTFE in this study was 1.8%.
In a study with 29 patients, one graft in a patient with severe diabetes became infected [Yoshida et al., 1996], whilst a larger trial reported 2 infections in 90 patients over an average of 38 months [Nakajima et al., 1996].
One study reported an infection rate of 3.7% (4 patients) but the author associates this with the high frequency of gangrenous lesions [Koch, 1990]. Three of these four patients were successfully treated with antibiotics without graft removal.
In AV access, Omniflow® has consistently fewer graft infections than PTFE
Several studies of Omniflow® as AV access graft report a consistently lower infection rate than in PTFE. Enzler et al. report infections in 2% of Omniflow® shunts but 10% of PTFE shunts [Enzler et al., 1996]. Wang and Chu reported a slightly higher rate of graft infection that could not be treated with antibiotics (2.38% vs 1.92% per patient year) in PTFE than in Omniflow®II [Wang&Chu, 1996].
Resistance to Aneurysm formation
Omniflow® has demonstrated long-term durability due to the strong synthetic component of the vessel wall. This sets Omniflow® apart from all pure biological grafts.
Omniflow® has consistently demonstrated a low rate of aneurysm formation
The most comprehensive study of aneurysm formation covering 353 patients reports 2.55% aneurysm rate (9 patients) appearing on average 1763 days (4.83 years) after implantation [Amann et al., 2000].
A Japanese study covering above-knee bypass in 29 patients reported no aneurysms [Yoshida et al., 1996] and a larger study reported 4 aneurysms among 90 patients after a mean follow-up time of 38 months [Nakajima et al., 1996].
In AV access Omniflow® shows excellent resistance to the formation of aneurysms
Even after repeated puncturing, Omniflow® demonstrates very good durability and low rates of aneurysm formation. Wang and Chu reported an aneurysm rate of 0.96% per patient year in Omniflow® (vs. 2.38% p.a. in PTFE) [Wang&Chu, 1996] and Enzler et al. reported 5% overall aneurysm formation in Omniflow® [Enzler et al., 1996]. |
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