Guidant Announces Completion of FDA Inspection of St. Paul Facilities and Responds to FDA's Observations; Company Continues to W
22 Septembre 2005 - 3:01PM
Business Wire
Guidant (NYSE:GDT) announced today that the U.S. Food and Drug
Administration (FDA) has completed its inspection of Guidant's
Cardiac Rhythm Management facilities in St. Paul, Minnesota, and
has provided Guidant a Form 483, noting several observations of
non-compliance, including an observation with commentary on two
specific trends in its INSIGNIA(R) and NEXUS(R) families of
pacemakers. Guidant has provided the FDA with a thorough written
response to the observations, describing the steps that Guidant has
taken and will be taking to address the FDA's observations. In
connection with its response, Guidant is issuing a physician
communication on two specific trends in its INSIGNIA and NEXUS
families of pacemakers. A copy of the physician communication can
be found at
http://www.guidant.com/physician_communications/insignia-nexus.pdf.
Guidant has taken action to increase the flow of information to
physicians and patients on device performance. Recently, Guidant
Cardiac Rhythm Management (CRM) published its 2005 Product
Performance Report, which may be reviewed at
http://www.guidant.com/physician/product_performance_report.pdf.
This report includes more specific information than was contained
in past such reports. A further enhancement to this report is
planned by the end of the year. In addition, Guidant has now
provided physicians with Advisory Updates on its PRIZM(R) 2 DR and
CONTAK RENEWAL(R) and RENEWAL 2 devices which were subject to
Physician Advisories previously communicated in June. The Advisory
Updates include updated rate of occurrence information and results
from returned product testing. The Advisory Updates may be found at
http://www.guidant.com/physician_communications/. "Our efforts to
provide product performance information in increasing quantity and
frequency to physicians and patients is well-underway," said Fred
McCoy, president, Cardiac Rhythm Management, Guidant Corporation.
"We will work closely with physicians, patients, the Heart Rhythm
Society (HRS) and other industry participants and stakeholders on
the broad issues highlighted at the recent HRS Policy Conference on
Pacemaker and ICD Performance." Guidant recently announced the
formation of an Independent Panel, chaired by Dr. Robert J.
Myerburg, Professor of Medicine and Physiology at the University of
Miami, to report on ways that Guidant can further enhance
capabilities in understanding, detecting and disseminating
important product performance information. In addition, the Panel
will make public its non-proprietary observations and
recommendations regarding these issues that may be useful to others
in the device industry, regulatory bodies, and clinical community.
The Panel held its first meeting last month. The Panel's goal is to
present its complete report within six months. Guidant Corporation
pioneers lifesaving technology, giving an opportunity for better
life today to millions of cardiac and vascular patients worldwide.
The company, driven by a strong entrepreneurial culture of more
than 12,000 employees, develops, manufactures and markets a broad
array of products and services that enable less invasive care for
some of life's most threatening medical conditions. For more
information, visit www.guidant.com.
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