Edwards Lifesciences is continuing to strengthen its position in the transcatheter aortic valve replacement(TAVR) market by revealing real world data for the Sapien 3 valve. The Irvine, CA-based company presented positive 30-data of the device at EuroPCR.

The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the PARTNER II studies of the Sapien 3 valve. Nearly 2,000 patients were involved and treated in more than 450 commercial centers around the U.S.

"These data comparing real-world outcomes with clinical study results in intermediate-risk patients treated with the Edwards Sapien 3 transcatheter heart valve demonstrated comparably positive outcomes including high survival rates and low rates of stroke," E. Murat Tuzcu, MD, chief academic officer and the chief of cardiovascular medicine at the Heart & Vascular Institute at Cleveland Clinic Abu Dhabi, said in a release.

Edwards first received FDA approval for a TAVR device in 2011. Since that time there have been several companies – each with varying degrees of success – that have tried to receive regulatory approval. So far, other than Edwards, only Medtronic has approval in both Europe and the U.S. to market a TAVR device.

Medtronic received FDA approval for the technology about four years ago. The Dublin-based company acquired the valve technology from Irvine, CA-based Corevalve in 2009 for $700 million.

Edwards path hasn’t exactly been a smooth one in the market lately. In March, the company announced it planned to submit additional data for its Sapien 3 Ultra valve before it files for CE mark, causing a slight delay in the product getting to the market.

During its earnings call in April, the company said it expects to complete enrollment in the additional trial patients this quarter, putting it on track to receive CE mark approval of the Ultra system in the second half of the year.

The firm’s CEO, Mike Mussallem said, “following discussions with FDA, we continue to feel confident in the U.S. approval of [the Sapien 3 Ultra] in late 2018."