Guidant Requests Independent Panel to Recommend Physician and Patient Communication Guidelines
23 Juin 2005 - 1:49AM
Business Wire
Guidant Corporation (NYSE:GDT) today 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. "The health and well
being of patients is our highest priority," said Ronald W. Dollens,
president and CEO of Guidant Corporation. "We believe that the
industry and the public have the opportunity to learn from the
experience that Guidant and its physicians and patients have been
through. Recent issues with some of our devices have highlighted
the need for clear guidelines for communication about infrequently
occurring events. Although Guidant certainly understands and
fulfills current regulatory reporting requirements, questions
remain as to how companies can most effectively engage in a
dialogue with physicians and patients. We believe that establishing
this panel is an appropriate step in finding answers to these
questions." Guidant proposes an independent, blue ribbon panel
comprised of nationally recognized leaders of both
electrophysiology and non-electrophysiology cardiology, as well as
an expert patient-consumer advocate, to provide formal and specific
recommendations regarding processes and methods to improve, among
other things: -- Surveillance and understanding of infrequently
occurring events among life-sustaining implantable devices that may
affect physician decisions for their patients; -- Assessment of
benefit and risk to the patients; and -- Processes of communication
to physicians and patients. "Guidant is committed to encouraging
the establishment of industry guidelines and processes for patient
notification systems, as we believe that patient safety and
communication is paramount," Dollens said. Guidant also welcomes
the announcement that the Heart Rhythm Society will form a Task
Force on Device Performance to develop uniform notification
standards to inform patients and physicians about device safety.
Guidant strongly supports this endeavor and the opportunity to
participate in this process. Guidant understands that FDA is
undertaking its own initiatives to address concerns about timely
and accurate risk communications to patients and physicians.
Guidant welcomes the FDA's continued leadership in this matter and
looks forward to participating in any effort undertaken by FDA.
Guidant (NYSE:GDT)
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