WASHINGTON The minimally invasive aortic heart valve replacement system from Edwards Lifesciences Corp performed better than a rival product sold by Medtronic Inc in the first head-to-head study of the two, according to data from a small German trial presented at a major heart meeting on Sunday.
While the results are unlikely to be seen as decisive, given the size and limited scope of the study, they could provide the Edwards sales force with a valuable marketing tool as the two companies vie for market share with their competing transcatheter aortic valve replacement (TAVR) systems.
Both systems employ a catheter to thread the new valve through an artery into place in the heart, sparing patients too frail for open heart surgery from the invasive chest cracking procedure. The Edwards Sapien XT uses a balloon to expand the compressed valve once it is in position in the diseased valve, while the Medtronic CoreValve has a special self expanding valve using an alloy that reacts to body heat to open.
In the 241-patient study conducted at five German hospitals, doctors using the Edwards balloon expandable system reported a success rate of 95.9 percent compared with a 77.5 percent success rate for those using the Medtronic alternative.
A successful procedure was defined as one in which the valve was implanted in the correct position and provided a tight enough seal to prevent blood leakage across the valve.
Patients receiving the Edwards valve also reported improvement in symptoms such as breathlessness, chest pain and dizziness 30 days after the procedure at a higher rate than those in the Medtronic group - 94.3 percent versus 86.7 percent.
"We have two main types of valves available for this procedure, and until now, there was no conclusive data about their relative effectiveness," Dr. Mohamed Abdel-Wahab, the study's lead investigator, said in a statement.
(Reporting by Bill Berkrot and Ransdell Pierson; Editing by Rosalind Russell)