European TAVI Trial Includes Larger Valve

Published date : 11 February 2013
Article date : 13 February 2013


Mass device reports that St. Jude Medical is expanding its European transcatheter aortic valve implantation study to include a larger 25mm valve in the treatment of patients with severe aortic stenosis.

The manufacturer's researchers implanted the first patient with a larger sized Portico transcatheter aortic valve as part of the medical device maker's ongoing Portico TF EU trial. The trial was launched to evaluate the 23mm valve and it has now been expanded to implant up to 50 patients with the 25mm version.

St. Jude won CE Mark approval for its Portico TAVI system in November 2012.  Other TAVI devices currently on the market place are produced by Edwards Lifesciences and Medtronic. Mass Device describes Boston Scientific as 'waiting in the wings along with several smaller contestants'.

Medtronic's CoreValve was the first TAVI system to launch in the European market followed by Edwards Lifesciences' Sapien. The latter beat CoreValve to the US market last year.

This year, Direct Flow Medical gained the CE Mark for its metal-free TAVI system which, according to the article, the company declares 'virtually eliminates aortic regurgitation.'

Source: Mass Device, 04 February 2013.

Read the full editorial here.


The Sapien valve was the runner-up in the Cardiology category of Which Medical Device of the Year 2012.  It was joint runner-up with CoreValve in the same category, in 2011.

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