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Obesity Devices And The FDA Review Process: An Interview With Lee Kaplan, MD

Executive Summary

In this sidebar to Obesity 2011: Back To Basics In Bariatrics, Medtech Insight interviewes Lee Kaplan, MD, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital and co-director of an upcoming meeting delineating best practices for clinical trials in the field of bariatrics.

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Obesity Intervention: A New Era Of Discovery And Innovation

Device manufacturers are developing several next-generation devices for the minimally invasive treatment of obesity. Many of these emerging devices not only mimic the restriction and malabsorption mechanisms involved in bariatric surgery, but are also designed to influence the metabolic responses that are key to losing weight, improving outcomes, and impacting chronic disease.

Obesity Intervention: A New Era Of Discovery And Innovation

Driven by a vast and underserved market in dire need of safer, less-invasive, more effective solutions, manufacturers are developing several next-generation devices for the minimally invasive treatment of obesity. Many of these emerging devices not only mimic the restriction and malabsorption mechanisms involved in bariatric surgery, but are also designed to influence the metabolic responses that are key to losing weight, improving outcomes, and impacting chronic disease. Indeed the obesity intervention paradigm is rapidly changing as ongoing research provides new insights into the underlying mechanisms behind obesity and bariatric surgery, heralding a new era where the primary treatment target for bariatric surgery is becoming disease specific, rather than targeted at obesity alone.

Obesity 2011: Back To Basics In Bariatrics

The market for obesity products has blockbuster potential, but it’s proven an elusive target for the medical device industry. The challenging regulatory environment, weak economy, and skittish investors have slowed the number of product launches in recent years, and there have been some high-profile setbacks for several potential weight loss therapies. But now, a "back to basics" movement, focused on understanding the physiological triggers behind obesity rather than simply restricting food intake, hopes to spur development of more effective minimally invasive weight loss solutions.

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