Edwards Lifesciences Corporation
ADJUSTABLE PERCUTANEOUS HEART VALVE REPAIR SYSTEM

Abstract:

Devices and methods for treating patients with functional tricuspid regurgitation (TR) who are unsuitable for surgery include an interoperative, adjustable-size coapting element on a catheter which may be implanted within the left or right side of the heart and extends upward into the vasculature and out of the body. The radial diameter of the coapting element can be modulated in tandem with electrocardiographic imaging to reduce valve regurgitation. One system has an elongated catheter and an expandable coapting element mounted to a distal end with an auxetic structure connected to opposite end caps. A tensioning mechanism controlled from a proximal end of the catheter is configured to pull apart the two end caps and thus elongate and radially expand the auxetic structure. Other forms of the coapting element are disclosed, as well as a kink-resistant catheter sheath having a triangular cross-section.