UroNova GmbH - Clinical Benefits

“Infection, encrustation and blockage of long-term indwelling catheters,
ureteral stents and nephrostomy tubes are significant medical and
health-economic problems. Because of these problems, about of 50%
of patients with permanent urinary drainage devices present as
emergency cases during their course of disease and produce costs of
up to 1.5 billion US$ per year in Western Europe and a similar amount
in North America.“

“Urinary catheter-related infections are commonly
seen in several different patient populations and
lead to substantial morbidity.”

“The additional direct costs of hospitalization
attributable to catheter-associated urinary
tract infection vary between $363 and $821.”

“Heparin-coated ureteral stents are more expensive than standard stents.
However, with longer indwelling times and reduction of the number of
stent exchange procedures, the total costs for heparin stents should be
reduced compared to other stents.”

Comparison of costs per year for ureteral drainage with
uncoated (PU) and coated UroNova DJ stents (Coated).

„This pilot study showed that no biofilms were detectable on heparin-coated
ureteral stents whereas significant bioflims were demonstrated in 33% of
uncoated stents. Mild incrustation was observed in 10% of heparin stents
compared to significant incrustation in 50% of uncoated stents.“

Above: Coated UroNova DJ stent
after 6 weeks indwelling time.
Below: Uncoated DJ stent after 6 weeks
in the same patient. Massive biofilm formation.

„Our studies show that heparin coated devices are protected
against incrustation and biofilm formation for a longer period
of time: 6 – 12 month, both in vitro and in vivo.“

Average number of germs on 1cm² uncoated
and heparin coated polyurethane stents in vitro.

„The heparinized silicone balloon catheters stayed patent for the
whole 6 – 8 weeks indwelling periods, whereas uncoated tubes
became obstructed within 2 - 3 weeks.“

Left: Coated UroNova balloon catheter after
6 weeks indwelling time.
Right: Uncoated balloon catheter after 2 weeks in
the same patient. Complete blockage by crystals.

“Cell growth studies with live / dead colouring under
fluororescence microscopy indicate living cells by a
green shine and dead cells by red colour. Incubation
of polypropylene suture for 48h at 37°C in Porcine Aortic
Endothelial Cell suspensions with 200,000 cells/ml and
subsequent live / dead colouring with calcein-AM and
ethidium dimer proofed a regular growth of vital cell
groups and their proliferation on a surface where without
coating no cell growth takes place.“

Left: Polypropylene with UroNova Cell Growth Coating.
Growth of vital cells.
Right: Uncoated polypropylene. No cell growth.

"Premature stent removal was necessary in 3/10 standard stents,
because of new jaundice or cholangitis, but in none of the coated
stents. After longitudinal incision, all three stents showed total or
partial occlusion. Altogether, coated stents showed less visible
occlusion and discolouration than standard stents. [...] With respect
to development of stent occlusion, heparin-coated plastic biliary
endoprostheses are significantly superior to standard polyethylene
stents."

[Farnbacher, UEGW 2008, P1533]

Left: Coated UroNova biliary stent after
98 days indwelling time.
Right: Uncoated biliary stent after 91 days in
the same patient. Complete blockage by deposits.