An FDA advisory panel says riskier medical devices for treating obesity should deliver more weight loss than less-risky treatments to justify the federal watchdog agency's approval.
High-risk medical devices intended to help obese patients lose weight should result in more weight loss than lower-risk methods, an FDA advisory panel said last week.
"For a 1-and-done [a permanently implanted device], or a device equivalent to a gastric bypass, you should have higher expectations of the weight loss," said panelist Dr. Steven Schwaitzburg, of Harvard Medical School. "Whereas, if we have lower-risk devices and are able to establish other types of endpoints like bridge [to surgery], exercise, etc., then [a lower bar for excess weight loss would be acceptable]."
Treating obese patients has a high public health impact, but obesity treatments present difficult trade-offs, the FDA's gastroenterology and urology devices advisory panel underscored during the meeting May 10-11 in Gaithersburg, Md.
Obesity has reached epidemic proportions in the U.S., more than doubling since 1960. Some 36% of adults are categorized as obese, as are 18.1% of adolescents and 19.6% of children 6-11, according to the National Institutes of Health and the Journal of the American Medical Assn. . .View Full Article