There ’s a New Weight-Loss Device in Town and TPS Is Its Name

Earlier this year, MD+DI reported there were some significant changes occurring in the obesity treatment market. The latest change in the space is the addition of BAROnova’s weight-loss product to the U.S. market. The San Carlos, CA-based company won a nod from FDA TransPyloric Shuttle (TPS) device, a non-surgical obesity treatment technology for patients with a body mass index of 30 to 40kg/m2. BAROnova said the device is approved for up to one year of treatment, during which time patients undergo lifestyle modification counseling to help develop and maintain healthier habits. The TPS device is delivered and retrieved endoscopically and relies on its mechanical structure to maintain its shape to keep it in the stomach as opposed to traditional inflatable intragastric balloons. The constructed TPS is the size of a small peach (~5.6 cm in diameter), 85% to 90% smaller than the fluid-filled balloons. Once in stomach, it is designed to slow the passage of food, so patients feel full sooner and stay full longer. The 12-month treatment duration is twice as long as intragastric balloons currently approved in the U.S. The longer treatment duration potentially allows patients the opportunity to achieve more durable lifestyle changes and health benefits. "FDA approval is a significant milestone for the company," Lian Cunningham, M.D, PhD, Senior Vice President of Clinical Affairs and Regulatory Affairs of BAROnova, said in a release. "The TPS device is unique in its ...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news