FDA clears new EndoFLIP catheter
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for a new EndoFLIP catheter, developed by Crospon, to measure sleeves created during bariatric surgery. The minimally-invasive procedure to treat obesity involves removing part of the stomach, leaving the remaining part in the shape of a tube or sleeve. The EndoFLIP EF620 sleeve catheter can ensure that this sleeve is not too small, thereby reducing the risk of leaks. EndoFLIP originally received 510(k) clearance in December 2009 to allow bariatric surgeons to measure and set gastric band stoma size during surgery (www.clinica.co.uk, 12 January 2010). Galway, Ireland-based Crospon CE marked EndoFLIP for sale in Europe in January 2009, which covered its use in the measurement of sleeves.