ReShape Lifesciences receives Health Canada approval for Lap-Band 2.0 FLEX

ReShape Lifesciences (RSLS) announced that Health Canada has updated the Medical Device License granting approval for the company’s next generation, enhanced Lap-Band 2.0 FLEX and Tubing Kit. “Approval by Health Canada for the Lap-Band 2.0 FLEX is yet another significant milestone for ReShape and an important growth catalyst for the company’s Lap-Band(R) franchise,” stated Paul Hickey, President and Chief Executive Officer of ReShape Lifesciences. “As a reminder, the enhanced Lap-Band 2.0 FLEX was designed with physician feedback with the goal of improving the patient experience. Like the current Lap-Band, Lap-Band 2.0 FLEX can be adjusted postoperatively to increase or decrease the band opening, thus optimizing eating habits and comfort. Additionally, Lap-Band 2.0 FLEX has a new feature called Flex technology, which acts as a relief valve, enabling larger pieces of food to pass through the narrowed passage more easily. Specifically, the band momentarily relaxes before returning to its resting diameter, while minimizing discomfort caused by swallowing large food pieces. Recently, we have successfully completed the limited market release of the Lap-Band 2.0 FLEX in the U.S., and initial surgeon feedback has been overwhelmingly positive, we are analyzing data and metrics that will be used to support our U.S. commercial launch. Additionally, we now look forward to launching the product in Canada in the near future.”