The FDA has granted approval of a PMA supplement for ReShape Lifesciences’ next generation, enhanced Lap-Band 2.0 FLEX. According to the company, the enhanced Lap-Band 2.0 FLEX 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, minimising discomfort caused by passage of large food pieces through the stoma.
“Based on my 20-year use of the Lap-Band, over time, some patients have needed adjustments, particularly when related to urgent loosening to relieve food obstruction,” said Dr Christine Ren-Fielding, Professor of Surgery at NYU Grossman School of Medicine, Director of the NYU Langone Weight Management Program and Chief of the Division of Bariatric Surgery. “Lap-Band 2.0 FLEX will potentially remedy this issue because of the ability for self-correction, utilising an internal reservoir system. In addition, multi-modal therapy is becoming a mainstay in the bariatric surgery field. GLP-1 agonists can be used to complement and augment weight loss after surgery to help prevent weight regain.”
“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,” added Paul Hickey, President and Chief Executive Officer of ReShape Lifesciences. “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 US product launch of the Lap-Band 2.0 FLEX and look forward to providing updates on our progress.”
ReShape Lifesciences integrated portfolio of proven products and services includes the investigational Diabetes Bloc-Stim Neuromodulation system that utilises a proprietary vagus nerve block and stimulation technology platform for the treatment of Type 2 diabetes and metabolic disorders and Obalon balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss.