Edwards Lifesciences Corp. said Tuesday that regulators approved the use of a catheter in its ongoing Sapien heart valve clinical trial.
The Irvine heart valve maker said in a statement that the Food and Drug Administration approved the addition of its Ascendra catheter to the Sapien trial.
The Sapien valve is being tested for patients who are considered high-risk or inoperable for open heart surgery. Ascendra helps allow for the insertion of Sapien through a patient’s ribs, which is less invasive.
Regulators also allowed Edwards to expand the Sapien trial’s size from 600 to 1,040 patients.
Edwards already markets Sapien with Ascendra and another delivery system in Europe. The valve is seen as a key new product for Edwards, a leading maker of valves implanted during major surgery.
