This is a brief overview of information related to FDA's approval to market this product. 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.

Product Name: LOTUS Edge™ Valve System
PMA Applicant: Boston Scientific Corporation
Address: 300 Boston Scientific Way, Marlborough, MA 01752-1234
Approval Date: April 23, 2019
Approval Letter: Approval Order

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. 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. The valve is available in three sizes: 23 mm, 25 mm, and 27 mm.

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 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. The handle of the delivery system is used to mechanically expand the LOTUS Edge™ Valve until it secures to the patient's diseased valve. Then the valve is released and the delivery system is taken out of the body. Once in place, the new valve functions the same as the old valve by opening and closing properly to guide the blood flow in the right direction.

When is it used? LOTUS Edge™ is used in patients whose aortic heart valve is diseased due to calcium build up, which causes the valve to narrow (aortic stenosis) and restricts blood flow through the valve. As the heart works harder to pump enough blood through the smaller opening, the heart eventually becomes weak. This can lead to symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or abrupt loss of heart function (cardiac arrest).

The LOTUS Edge™ valve is used in patients who cannot undergo, or are at high risk for open heart surgery as determined by their heart team (a cardiologist and surgeon).

What will it accomplish? LOTUS Edge™ can help restore normal blood flow in the hearts of patients with severe aortic stenosis who need replacement of their diseased valve, but for whom the surgical procedure is highly risky, or too risky. For these patients, clinical studies showed that LOTUS Edge™ is reasonably safe and effective and patients showed improvement in how their heart functioned without the need for open heart surgery. However, implanting the LOTUS Edge™ also carries the risk of serious complications such as death, stroke, kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.

When should it not be used? The LOTUS Edge™ Valve System should not be used in patients who:

• do not have calcium build up in their native diseased aortic valve
• have an infection in the heart or elsewhere
• have known sensitivity or allergy to any materials in the valve or who cannot tolerate blood thinning medications
• have blood vessels that are too difficult to navigate and would prevent the device from being placed properly

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Patient Labeling: LOTUS Edge Valve System Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
• Physican Labeling: LOTUS Edge Valve System Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
• PMA Database Entry