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Clinical Studies

Omniflow II is covered by a large number of clinical publications. These publications demonstrate that Omniflow II possesses:

Download a Summary of Key Publications on Omniflow.
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Good long-term patency

Several randomised studies have compared Omniflow to PTFE in above-knee, below-knee and arteriovenous positions.

In randomised studies Omniflow demonstrated statistically significantly better patency than PTFE in below-knee settings.

In a study which also examined the patency of Omniflow and PTFE grafts in the below-knee setting, Omniflow was found to be statistically significantly better than PTFE after 3 years [Koch et al., 1996].

Long-term patency for Omniflow II of up to 65% has been reported.

Long term follow-up of Omniflow II in 42 patients with peripheral bypass grafts demonstrated long-term primary and secondary patency rates of 52% and 65% respectively after 3 years [unpublished data presented by Mr P. Field, Royal Melbourne Hospital to the Royal Australasian College of Surgeons, 1996].

The longest known case of patency without intervention has been over ten years.

Cumulative patency for Omniflow^®II

Very high patency rates demonstrated for Omniflow II in above-knee bypass surgery.

A clinical publication has reported a 3-year secondary patency rate for Omniflow in the above-knee femoropopliteal position of 76% for patients with 2-3 vessel runoff (n=67) and 65% for patients with 0-1 vessel runoff (n=47) [Bull et al., 1991].

In one group of 29 patients, Omniflow II demonstrated primary and secondary patency rates of 83% and 91 % respectively after 3 years [Yoshida et al., 1996].

In procedures for arteriovenous access for haemodialysis, Omniflow has demonstrated patency rates from 68% to 77% after one year.

In several studies Omniflow has demonstrated high patency rates in arteriovenous access procedures. Three separate studies have reported assisted patency rates at 12 months between 68 and 77%, and after three years of 42-48% [Enzler et al., 1996; Wang&Chu, 1996; Berardinelli et al., 1990]. The comparative assisted patency rates for PTFE were consistently 8-28% lower at 1 year and 5-20% lower at 3 years.

Enzler et al. reported that Omniflow did not have significantly lower patency than the autologous arteriovenous fistula (AVF), however, the patency rates for both PTFE and bovine xenograft were significantly below AVF [Enzler at al., 1996].

Berardinelli at al. reported that Omniflow had a patency rate not significantly different from their best material, homologous saphenous vein, whereas bovine carotid, PTFE, and autologous saphenous vein performed significantly worse [Berardinelli et al., 1990].

Several randomised studies have compared Omniflow to PTFE in above-knee, below-knee and arteriovenous positions. In randomised studies Omniflow demonstrated statistically significantly better patency than PTFE in below-knee settings.
In a study which also examined the patency of Omniflow and PTFE grafts in the below-knee setting, Omniflow was found to be statistically significantly better than PTFE after 3 years [Koch et al., 1996].
Long-term patency for Omniflow II of up to 65% has been reported.
Long term follow-up of Omniflow II in 42 patients with peripheral bypass grafts demonstrated long-term primary and secondary patency rates of 52% and 65% respectively after 3 years [unpublished data presented by Mr P. Field, Royal Melbourne Hospital to the Royal Australasian College of Surgeons, 1996]. The longest known case of patency without intervention has been over ten years.	Cumulative patency for Omniflow^®II
Very high patency rates demonstrated for Omniflow II in above-knee bypass surgery. A clinical publication has reported a 3-year secondary patency rate for Omniflow in the above-knee femoropopliteal position of 76% for patients with 2-3 vessel runoff (n=67) and 65% for patients with 0-1 vessel runoff (n=47) [Bull et al., 1991].
In one group of 29 patients, Omniflow II demonstrated primary and secondary patency rates of 83% and 91 % respectively after 3 years [Yoshida et al., 1996].
In procedures for arteriovenous access for haemodialysis, Omniflow has demonstrated patency rates from 68% to 77% after one year. In several studies Omniflow has demonstrated high patency rates in arteriovenous access procedures. Three separate studies have reported assisted patency rates at 12 months between 68 and 77%, and after three years of 42-48% [Enzler et al., 1996; Wang&Chu, 1996; Berardinelli et al., 1990]. The comparative assisted patency rates for PTFE were consistently 8-28% lower at 1 year and 5-20% lower at 3 years.
Enzler et al. reported that Omniflow did not have significantly lower patency than the autologous arteriovenous fistula (AVF), however, the patency rates for both PTFE and bovine xenograft were significantly below AVF [Enzler at al., 1996].
Berardinelli at al. reported that Omniflow had a patency rate not significantly different from their best material, homologous saphenous vein, whereas bovine carotid, PTFE, and autologous saphenous vein performed significantly worse [Berardinelli et al., 1990].