Investigational treatments

Minimally invasive transcatheter aortic heart valve replacement
Between the ribs approach

Performed without traditional open heart surgery, this minimally invasive aortic valve replacement procedure is being investigated in a clinical trial involving patients with severe aortic stenosis (a narrowing of the valve that restricts blood flow), who are considered either high-risk or non-operable for open-chest surgery. The transapical approach utilizes the Edwards SAPIEN transcatheter heart valve, which combines balloon expandable stent technology with a bovine pericardial bioprosthetic tissue valve. The valve is mounted on the Ascendra transapical valve delivery system, which is inserted through an incision between the ribs into the apex of the left ventricle and delivered to the site of the patient’s diseased valve.

		Edwards SAPIEN transcatheter heart valve Once it reaches the site of the diseased or "stenotic" valve, the Edwards SAPIEN transcatheter heart valve (available in two sizes, 23 mm and 26 mm), is positioned and deployed across the patient's stenotic valve.
	Stenotic native                                                   aortic valve The physician utilizes echocardiographic and fluoroscopic guidance for visualization during the valve delivery. This minimally-invasive approach is intended to be performed under general anesthesia. Prior to implantation, the valve is carefully mounted and crimped onto the balloon delivery catheter. The valve/balloon assembly is inserted through the ribs, into the apex of the left ventricle and delivered with the Ascendra transapical delivery system to the site of the patient's native diseased valve.