CryoCor begins AF (atrial fibrillation) cryotherapy trial:
This article was originally published in Clinica
The US FDA has given CryoCor the go-ahead to begin a feasibility study of its minimally invasive cardiac cryoablation system for treating atrial fibrillation (AF). The study will involve around 30 patients at up to five centres and will assess the San Diego, California firm's system, called CryoCor, as a treatment for paroxysmal, or intermittent, AF. Patient follow-up of the trial is scheduled for completion by the fourth quarter of 2002, after which CryoCor plans to file for FDA approval to begin a pivotal US trial to support a marketing application for the device. The device has yet to be CE-marked for sale in Europe.