Stent trial proceeding
July 16, 2012
REVA Medical, a dual listed US-Australian
research firm, has
completed clinical enrolment for a
clinical trial of its ReZolve drugeluting
bioresorbable scaffold.
26 patients have been enrolled
since Dec last year and there are no
major adverse coronary events
reported to date.
The company anticipates
resumption of clinical trials in the
fourth quarter of 2012, when
patients will be treated with a
lower profile ReZolve2 scaffold
which will be evaluated at up to 25
clinical study sites in Brazil, Europe,
Australia and New Zealand.
ReZolve 2 combines REVA’s
proprietary stent design with a
polymer that is metabolised and
cleared from the body, and offers
full x-ray visibility and a controlled
and safe resorption rate.
Early encapuslation of the stent in
the artery tissue combined with the
loss of the scaffold structure over
time is hoped to reduce the
incidence of late forming blood
clots or thrombosis, which is a “rare
but serious problem associated
with drug-eluting metal stents
currently on the market”.
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