Investigational treatments

Minimally invasive transcatheter aortic heart valve replacement
Leg artery 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 high-risk or non-operable for open-chest surgery. The transfemoral 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 RetroFlex transfemoral valve delivery system, which is inserted into the femoral artery, tracked over the aortic arch and delivered to the site of the patient's diseased valve — all without cardiopulmonary bypass.

		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 local and/or general anesthesia. Prior to implantation, the valve is carefully mounted and crimped onto the balloon delivery catheter. The valve/balloon assembly is inserted into the femoral artery and delivered with the RetroFlex transfemoral delivery system to the site of the patient's native diseased valve.

To obtain details regarding current clinical trials for this investigational treatment, please visit the ClinicalTrials.gov website.