Devices

‘Conflicted’ Device Panel Chair Granted Participation Waiver

FDA has granted a waiver for Circulatory System Devices Panel chairman Richard L. Page despite a conflict of interest when the panel reviews and votes 5/24 on a St. Jude Medical PMA for its Amplatzer PFO Occluder. The device is intended to be permanently implanted to close patent foramen ovale in order to prevent recurrent stroke in patients who have had a cryptogenic stroke due to presumed paradoxical embolism.

Page is chair of the University of Wisconsin School of Medicine and Public Health’s Department of Medicine. The school has been identified as a clinical site for a study involving the Amplatzer device, and as such it has received funding from the company, according to an agency waiver notice. However, it says, Page is not personally involved with the study, but its study investigator is on the faculty of the Division of Cardiovascular Medicine, which is under Page’s supervision.

In granting the waiver, FDA notes that Page is a highly regarded clinical cardiologist, electrophysiologist and clinical trialist. “We expect that the panel deliberations will be complex and potentially contentious, such that an experienced chair like Dr. Page is essential,” it says. Dr. Page has a full understanding of the benefit-risk issues associated with PFO closure.”

Additionally, in further justifying the waiver, FDA says the Amplatzer PFO trial included 925 subjects at 62 U.S. sites. “Due to the large number of study sites, it was very difficult to identify panelists with relevant expertise who had no affiliation with a clinical study site for the PFO Occluder advisory panel,” it says. “In our panel preparation process, we approached multiple individuals who have experience in these areas, but were unsuccessful in finding the range of experience equivalent to that of Dr. Page.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome