Bariatric Surgery Gets Formal Nod As Diabetes Treatment In Guidelines
This article was originally published in The Gray Sheet
Surgical procedures, including sleeve gastrectomy and laparoscopic adjustable gastric banding, have captured more attention as treatment options for type 2 diabetes. The first consensus clinical guidelines have now been published endorsing that approach for certain patients.
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With no end in sight for the obesity epidemic, there is a vast and underserved market opportunity for manufacturers developing minimally invasive solutions for obesity that can fill the treatment gap between invasive bariatric surgery and conservative weight loss methods (diet, exercise, and drugs). Despite some high-profile setbacks in the last few years, the market for minimally invasive bariatric devices is gaining steam as several companies have recently launched obesity devices on the US market while others have completed clinical trials and are advancing toward US regulatory approval.
Nearly half of the world’s adult population will be overweight or obese by 2030 and obesity is tied to more than 40 diseases. Enterprising companies are heeding the call with increasingly less invasive weight loss devices, while an amenable regulatory environment means the marketplace will welcome some of these innovations in 2015.
Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.