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# FDA Approves Edwards Intuity Valve System
- URL: https://www.fdaweb.com/fda-approves-edwards-intuity-valve-system/
- Published: 2016-08-15T12:00:00.000Z
- Updated: 2026-09-14T21:24:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136507

FDA has approved an Edwards Lifesciences PMA for its Intuity Elite valve system, a rapid deployment device for surgical aortic valve replacement. Built on the company’s Perimount tissue valve platform, the device is supported by data from the TRANSFORM clinical trial, which treated 839 patients in 29 centers in the U.S. The data showed that, at one year, the “valve system is safe and effective and may reduce cross-clamp time and cardiopulmonary bypass time, compared to times recorded in the Society of Thoracic Surgeons' (STS) Adult Cardiac Database,” Edwards says. This may provide patient benefits such as decreased mortality and morbidity, less time in an intensive care unit and reduced total hospital stay. The device was approved for use in Europe in 2014.