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Current Postings on This Page (4):
The approval track for these new stents is long
-- because of problems with some devices in the past, the FDA has been
more stringent on making sure large studies have been done and followed
up sufficiently
before
approving
a
stent for
general
use. As for recovery time, that is not something that is sensed by the
patient and would have little to do with the "healing" of the arterial
wall, but more
the
patient
adjusting
to new
medications
and increased blood flow, etc. Angioplasty.Org Staff,Angioplasty.Org, July 10, 2009
My mother-in-law had to have a stent put in a
few years ago. The surgery was really rough on her and recovery took
longer than the Doctor prepared her to. You stated that this type of stent
has
a faster healing time, can you detail that (why) please? Also, do you
feel this will be made available in the US any
time soon? Thank you! Workemail, Indianapolis, Indiana, June 30, 2009
Psatha -- the JANUS Optima has the CE mark, but
it's not approved in the U.S. or Japan. The stent is stainless-steel, but
coated
with Carbofilm™ which the company thinks may reduce problems in patients
hypersensitive to nickel, and also heal faster. The drug is tacrolimus
and, uniquely, there is no polymer which some cardiologists feel is a distinct
advantage. However in a disappointing early trial, no differences in results
were found between the JANUS Optima and a non-DES carbostent. The chief
investigator, Dr. Marie-Claude Morice, feels there may still be
promise -- perhaps the drug dosage needs to be higher. This story is not
unlike that of the Conor CoStar -- a stent which seemed like a clearly
superior idea wound up not performing as well. Cordis bought Conor and
is re-launching the CoStar with a different drug and design modification
as the NEVO. Angioplasty.Org Staff,Angioplasty.Org, May 4, 2009
What about Optima des from Sorin-cid? Psatha Maria, demo s.a greece, Athens, Greece, May 4, 2009