Transcatheter heart valves to treat aortic heart valve disease became a reality a year ago in the US after Edwards Lifesciences received approval for its Sapien transcatheter aortic heart valve. TAVI (also known as TAVR?the name is continuously in flux, and lovingly debated) was approved based on the Cohort B data from the PARTNER trial, allowing the valves to be used in patients who were deemed ineligible for open-heart surgery. US physicians rejoiced at finally catching up to their European counterparts, who had been performing these procedures for half a decade. Last Friday, the FDA approved expanded indications for TAVI to include high-risk surgical patients and also approved the transapical route to complement the approved transfemoral route. This approval was based on the second half of the PARTNER Trial, Cohort A. Combined with the fact that the Cohort B study is continuing to have positive results?data now out to 3 years shows that 4/5ths of the control group had died, while only half of the patients treated with the Sapien had passed away?TAVI continues to be an exciting topic.
TAVI has been a huge focus of this year's Transcatheter Cardiovascular Therapeutics (TCT) conference, with those talks filling up quickly. The attitude in talks surrounding TAVI has undergone a significant transformation, however. The debates and questions surrounding if TAVI should actually be used have largely subsided, and it feels as if physicians are now comfortable with this procedure. Discussions now focus on how to improve the procedure, best practices, and new device iterations. The field is definitely advancing rapidly, with new competitors launching valves in Europe, and multiple smaller companies developing valves with innovative designs to build on limitations in previous generations of valves.
About that. One of the continued undertones of this year's talks is the gap between US and European devices, where US physicians can only dream of the devices their European counterparts have access to. Presenters debated how this is likely to play out in the future. Will the FDA continue to require extensive trials for each valve iteration before receiving approval? Will there be a shift to allow new devices onto the market more quickly? If things continue along the same path though, the global TAVI market will likely mirror that of the drug-eluting stent market: a robust and competitive European market with a wide variety of product choices compared to a severely limited selection in the US.
Stay tuned for more from TCT 2012.