|
April 8, 2004
Background
The
CYPHER® drug eluting stent from Johnson & Johnson / Cordis
was
first
given
U.S. approval on April 24,
2003, the first such device to receive this clearance.
According to Martin Schildhouse of Cordis it has been implanted
in
600,000
patients
worldwide,
450,000
of
whom
are in the
United States. Drug-eluting stents are revolutionary new devices
that reduce restenosis (reblockage) rates from 20-30% down
to single digits (see our overview article on "Drug-Eluting
Stents").
GMP Warning -- "Products Are Safe"
A letter delivered to Cordis last Friday
listed a number of observed deficiencies in "Good Manufacturing Practice" guidelines
and quality systems regulations (an exhaustive list of resources
in this area can be found on the
FDA
website on GMP). The observations describe problems
found at Cypher stent plants in the Netherlands, Belgium, Puerto
Rico,
as well
as U.S. sites in New Jersey and Florida. They reportedly involve
documentation, packing and storage, complaint processing, and
manufacturing processes.
FDA spokesperson Sharon E. Snider stated,
"Patients who have these stents should not be concerned."
Mr. Schildhouse of Cordis told
Angioplasty.org that "first and foremost is Cordis'
focus on patient safety". He and Snider both noted that
no stent has been recalled. Mr. Schildhouse continued that
these observations came about
as part of the standard
post-approval
inspections and that
Cordis
has
been
actively
engaged with
the FDA from the beginning to resolve the outstanding issues.
He stated that drug-eluting stents are a complex new technology,
that there are GMP issues and that the company is focusing
on them. Cordis issued a press
release to explain its position.
Meaning for Patients
While there seems to be no safety issue involved here, Angioplasty.org
recommends that patients discuss any concerns with their physicians.
A successful outcome depends to a great degree on a
partnership between doctor and patient, including strict adherence
by the patient to any medications prescribed for the post-stenting
period.
We welcome your
comments on this article.
Source: Angioplasty.org
CONTACT: Burt
Cohen, Producer of Angioplasty.org
|
