Jun 22, 2005
Guidant Requests Independent Panel to Recommend Physician and Patient Communication Guidelines

Indianapolis, Ind. - 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.