ReShape Lifesciences has submitted a Premarket Approval (PMA) supplement application to the FDA for the company’s next generation, enhanced Lap-Band 2.0, utilising a band reservoir technology.
According to the company, the Lap-Band 2.0 was developed with physician feedback to improve the patient experience and like its predecessor the Lap-Band 2.0 is adjustable postoperatively to increase or decrease the opening of the band in order to optimize an individual’s comfort, thereby improving therapy effectiveness.
However, unique to the Lap-Band 2.0 is its enhanced band reservoir technology that serves as a relief valve, designed to alleviate discomfort from swallowing large pieces of food, that may require in-office band adjustments.
“The PMA supplement submission is a significant milestone and is consistent with our second growth pillar to develop and, ultimately, commercialize new products and therapies,” said Paul Hickey, President and Chief Executive Officer of ReShape Lifesciences. “We expect feedback from the FDA by year end. If approved, we believe that based on discussions with physicians, that there will be broad adoption by existing Lap-Band surgeons and surgeons that newly adopt the Lap-Band 2.0.”