Medtronic (NYSE:MDT) today touted results from a study of its 3f Enable replacement heart valve, saying the sutureless aortic valve implant showed a 6% mortality rate after 5 years.
The 3f Enable valve is 1 of 3 sutureless devices on the market in Europe; the others are Sorin Group‘s (BIT:SRN) Perceval S and the Intuity valve from Edwards Lifesciences (NYSE:EW).
The 3f Enable study, a prospective, non-randomized trial, tracked 141 patients over 5 years beginning in January 2007. Thirty percent of those patients had some other type of heart procedure concomitant with the open heart surgery to implant the valves, according to the presentation.
The study results, presented today at the American Assn. for Thoracic Surgery’s annual meeting in Toronto, showed a 97% survival rate for valve-related mortality at 1 year and 94% at 5 years. Six patients underwent re-operation, 2 with endocarditis and 4 with major paravalvular leakage, all within 6 months of the initial surgery, according to the study. All 4 of the paravalvular leakage re-operation patients had PVL at discharge and no patients without PVL at discharge needed another operation, according to the trial.
Medtronic said the 3f Enable valve also showed low-single-digit gradients, which indicate blood flow through the valve.
"Until now, we didn’t know the medium- to long-term durability for this new device for fast aortic valve replacement," Dr. Thierry Carrel of the University Hospital Berne in Switzerland, who presented the data today, said in prepared remarks. "It’s very important that this sutureless valve performs very well, long after it’s implanted. Patients and physicians alike should be encouraged by this data."
"This is the first time we’ve seen five-year performance data of any sutureless valve on the market, and the results are quite impressive," added Medtronic structural heart president Dr. John Liddicoat. "The 3f Enable tissue heart valve not only provides a less invasive way to replace diseased, damaged or malfunctioning aortic valves, but now we know it performs well over time with excellent gradients, too."
Carrel reported receiving speaking fees and research support from Edwards, Sorin and Medtronic and consultant fees from Medtronic, Edwards and Getinge‘s (PINK:GETI B) Maquet subsidiary. He is also a shareholder in Swiss Cardiotech and ChordArt.
