FDA Approves Next-Gen Lap-Band

FDA has approved a ReShape Lifesciences PMA supplement for the company’s next-generation Lap-Band 2.0 FLEX, an implant indicated for weight reduction in patients with obesity. “Compared to our current Lap-Band, the Lap-Band 2.0 has a new feature called FLEX Technology, which acts as a relief valve, allowing larger pieces of food to more easily pass through the narrowed passage (or stoma), created by the band,” the company says.” Specifically, the band momentarily relaxes before returning to its resting diameter, therefore, minimizing discomfort caused by passage of large food pieces through the stoma.”

The device’s new design addresses physician input about making adjustments to relieve food obstructions. “Lap-Band 2.0 FLEX will potentially remedy this issue because of the ability for self-correction, utilizing an internal reservoir system,” the company says.