Edwards starts trial for new BioPhysio heart valve:
This article was originally published in Clinica
Edwards Lifesciences has begun a pivotal clinical trial of its next generation BioPhysio aortic valve, which it claims is the only replacement heart valve designed to mimic the physiologic motion of a natural heart valve. The valve combines the haemodynamic performance of a native valve with the ease of implant of a traditional stented valve, says the Irvine, California firm. The clinical trial is a large, multicentre study that will take place in Europe, Canada and the US. Enrolment is expected to last for around 18 months, followed by 12-18 months of post-procedural clinical monitoring and follow-up. Edwards hopes to start selling the device in Europe and Canada in 2008. US sales are expected to start later.