ReShape Lifesciences: FDA approves a PMA supplement for Lap-Band 2.0 FLEX

ReShape Lifesciences announced that the U.S. Food and Drug Administration FDA has granted approval of a PMA supplement for the company’s next generation, enhanced Lap-Band 2.0 FLEX. “PMA supplement approval for our next generation Lap-Band 2.0 FLEX is a historic event for ReShape that is expected to be a key growth catalyst for the company’s Lap-Band franchise,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “The enhanced Lap-Band 2.0 FLEX development effort was physician-led with the goal of improving the patient experience. 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. 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 Lap-Band system is the safest and most durable weight loss option for obese patients and is ideal for those who are averse to medically managed weight loss and who opt for the only available anatomy preserving surgery. We are preparing for our U.S. product launch of the Lap-Band 2.0 FLEX and look forward to providing updates on our progress.”