![]() ![]() Then the valve is released and the delivery system is taken out of the body. The handle of the delivery system is used to mechanically expand the LOTUS Edge™ Valve until it secures to the patient's diseased valve. The delivery catheter and valve are then inserted into the body through a blood vessel, usually an artery in the leg, and pushed through the blood vessels until it reaches the diseased aortic valve in the heart. How does it work? The LOTUS Edge™ valve is compressed and loaded inside the end of a tube-like device called a delivery catheter. The valve is available in three sizes: 23 mm, 25 mm, and 27 mm. The valve is made of natural tissue obtained from the heart of a cow that is attached to a metal (nickel-titanium) frame for support. What is it? The LOTUS Edge™ Valve System is a transcatheter aortic valve replacement system that consists of an artificial aortic heart valve and a delivery system used to implant the valve without the need for open-heart surgery. ![]() PMA Applicant: Boston Scientific CorporationĪddress: 300 Boston Scientific Way, Marlborough, MA 01752-1234 See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval. This is a brief overview of information related to FDA's approval to market this product. ![]()
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