Medical device heavyweight Medtronic (NYSE:MDT) won CE Mark approval in the European Union for a new size of its CoreValve Evolut transcatheter aortic valve implants, the company announced.

The new 23 mm valve, the smallest in the CoreValve suite, allows Medtronic to provide the "broadest range of TAVI patient valve sizes," according to a press release.

The CoreValve suite originally won European regulatory approval in 2007 and the company has approval to market 26 mm, 29 mm and 31 mm valve sizes as well.

The CoreValve system is a minimally invasive treatment option for patients with severe heart disease who are at high risk or unable to undergo open-heart surgery.

The devices have yet to make it to the U.S. market, where Medtronic has investigational device exemption for its CoreValve product line and rival medical device maker Edwards Lifesciences (NYSE:EW) currently has the corner on the TAVI market.

CoreValve was the first TAVR system to hit the market when it won CE Mark approval in the European Union in March 2007. Edwards Lifesciences (NYSE:EW) won CE Mark approval for its Sapien TAVR system in September of that year and landed FDA clearance for its Sapien system in Nov. 2011.

Medtronic has said that it expects CoreValve to clear U.S. regulatory hurdles in 2014. The device has already been implanted in more than 30,000 patients around the world, according to a press release.