US trials go-ahead for Nitinol septal occluder:
This article was originally published in Clinica
The FDA has agreed to trials of Nitinol's Cardioseal septal occluder. The device is a heart implant designed to close transient holes (patent foramen ovale) in the atrial septum and is being used routinely at some European hospitals, said Nitinol. The US trials will begin at up to 15 sites later in the spring, after some protocol changes demanded by the FDA.