Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Certain
18 Juillet 2005 - 2:04PM
Business Wire
Guidant Corporation (NYSE:GDT) said today it is voluntarily
advising physicians about important safety information regarding
certain devices. Guidant apprised FDA of this action, and FDA may
classify this action as a recall. This communication advises
physicians and their patients of safety information and is intended
to limit adverse events. Physicians should use this information to
decide how best to treat their patients. A subset of the following
devices manufactured between November 25, 1997 and October 26, 2000
are impacted: -- PULSAR(R) MAX -- PULSAR -- DISCOVERY(R) --
MERIDIAN(R) -- PULSAR MAX II -- DISCOVERY II -- VIRTUS PLUS(R) II
-- INTELIS II -- CONTAK(R) TR These products, which are of an
earlier generation design, have not been sold or implanted for the
last four years. Guidant has determined that a hermetic sealing
component used in the subset of devices listed above may experience
a gradual degradation, resulting in a higher than normal moisture
content within the pacemaker case late in the device's service
life. As of July 11, 2005, Guidant has identified sixty-nine (69)
devices that may have exhibited this failure mode from
approximately 78,000 devices distributed with this component. While
no failures have been reported prior to 44 months of service, the
likelihood of occurrence increases with implant time. Guidant's
modeling based on field experience and statistical life-table
analysis predicts the rate of failure in the remaining active
implanted devices to be between 0.17% and 0.51% over the remaining
device lifetime. Of the 78,000 devices originally distributed,
approximately 28,000 devices remain implanted worldwide; 18,000 of
these devices remain in service in the United States with an
average implant age of 69 months. It is Guidant's recommendation to
physicians that they consider the unique needs of individual
patients and the specific technical recommendations set forth in
Guidant's physician communication, dated July 18, 2005. In
addition, Guidant recommends that physicians consider replacing
devices for pacemaker-dependent patients. In addition, Guidant
advises patients to seek medical attention immediately if they
notice shortness of breath, dizziness, lightheadedness or a
prolonged fast heart rate. The clinical behaviors associated with
this failure mode can result in serious health complications.
Guidant has confirmed twenty reports of loss of pacing output
associated with this failure mode, including five patients
experiencing syncope. Loss of pacing output has also been
associated with reports of presyncope requiring hospitalization.
Additionally, Guidant has received two reports of sustained Maximum
Sensor Rate ("MSR") pacing in which heart failure may have
developed in association with sustained high rate pacing. In one
report, a patient whose device exhibited sustained MSR pacing was
admitted to the hospital with multiple health issues and later
died. It is unknown if this device experienced the failure
described above as the device was not returned and this failure
mode could not be confirmed. Many of these devices are nearing or
have exceeded their estimated longevity and have thus outlived
their warranty. Guidant will provide a replacement device at no
charge for pacemaker-dependent patients and other patients deemed
by their physicians to be best served by replacement, provided the
replacement occurs prior to the normal appearance of elective
replacement indicators. This supplemental warranty program is
available through December 31, 2005. Additionally, Guidant will
reimburse patients up to $2,500 for medical expenses remaining
after Medicare and/or health insurance coverage, including device
replacement or additional follow-up procedures. "The health and
safety of patients is paramount," stated Ronald W. Dollens,
president and CEO, Guidant Corporation. "Our innovative
technologies have saved and improved millions of lives. Guidant
works diligently to create the most reliable products and services,
enhance patient outcomes, and limit adverse events to patients."
The actions taken by the company over the last several weeks
reflect our commitment to provide more timely information to
physicians and patients about our devices. Guidant has worked
closely with FDA since the announcement of the physician
communications, and has made FDA aware of all Guidant statements
set forth in prior press releases, physician communications, and
patient letters on this matter. Guidant will continue to work to
meet and exceed the expectations of physicians, patients and FDA.
Guidant recently announced its intention to establish an
independent panel of experts to recommend guidelines for when to
disseminate information to physicians and patients about
life-sustaining implantable devices. Guidant plans to cooperate
with and enlist the support of other interested parties. Additional
information about this potential issue is available for physicians
and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and
http://www.guidant.com/physician_communications/PDM.pdf. This
release includes forward-looking statements concerning the course
of developments with respect to the affected products. These
statements are based on assumptions about many important factors,
including continuing developments with respect adverse event rates,
regulatory agency actions, and other factors identified on Exhibit
99 to the company's most recent 10-Q. Actual results may differ
materially. The company does not undertake to update its
forward-looking statements.
Guidant (NYSE:GDT)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Guidant (NYSE:GDT)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024
Real-Time news about Guidant Corp (New York Stock Exchange): 0 recent articles
Plus d'articles sur Guidant Corporation