FDA okays MTI's (Micro Therapeutics) Onyx brain aneurysm trial:
This article was originally published in Clinica
The US FDA has given Micro Therapeutics (MTI) the go-ahead to begin a 138-patient pivotal trial of its Onyx liquid embolic system for the treatment of brain aneurysms. The product, which is already CE-marked for sale in Europe (see Clinica no 934, p 17), will be tested in 15 US sites. The Irvine, California company says it expects to file a PMA application with the FDA in the second half of 2002.