FDA Approves Two New TAVR Systems for High-risk, Inoperable Patients

Over the past four years, transcatheter aortic valve replacement has become an established treatment option for high-risk, inoperable patients with severe aortic stenosis.

Aortic valve stenosis is the most prevalent heart valve disease in the Western world, and it has a poor prognosis after symptom onset.¹ Surgical aortic valve replacement (AVR) is an effective treatment for severe aortic stenosis and is considered to be the gold standard of care.² It has been proven to provide symptomatic relief and long-term survival in adults. During the surgical valve replacement procedure, the damaged “native” heart valve is removed and replaced with a prosthetic valve. Surgical AVR is recommended for virtually all adult patients who do not have other serious medical conditions.

For patients who have been deemed inoperable for traditional open-heart surgery, a new procedure called transcatheter aortic valve replacement (TAVR) is now available as a treatment option. In November of 2011, the U.S. Food and Drug Administration (FDA) approved the first transcatheter heart valve for the treatment of patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement. This new transcatheter procedure allows the diseased native heart valve to be replaced without open-heart surgery.³

In the past month, two new TAVR valves have been approved by the FDA. Earlier in June, the third generation of the first approved Edwards Sapien valve was cleared by the FDA. The Edwards Sapien 3 valve has a main design change that includes the addition of a skirt at the base of the valve intended to minimize paravalvular leak. The FDA also approved the first self-expanding valve, the CoreValve Evolut R manufactured by Medtronic, for use in patients at extreme or high risk for surgery. This device is the first fully recapturable and repositionable transcatheter valve available in the United States.

In a short period of four years, the TAVR procedure has become an established treatment option for high-risk, inoperable patients with severe aortic stenosis. There are several other manufacturers involved in clinical trials for the next generation of transcatheter valves to be released over the next year or so.

Ross J Jr., Braunwald E. Aortic stenosis. Circulation, 1968; 38:61–7.
Carabello BA, Paulus WJ. Aortic stenosis. Lancet 2009; 373:956–66.
Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. New England Journal of Medicine 2011; 364: 2187–98.

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Author Information

Robin Cunningham, RN

Robin Cunningham, RN, is a director for Physician Services at HealthTrust. A cardiovascular care specialist, she previously served as a clinical director for SourceTrust and, prior to that, served in leadership positions with HCA for 25 years. Cunningham works with HealthTrust members on medical device contracting projects, product analysis, spend review and physician engagement. She is a member of the American College of Cardiology, serving as state liaison for Tennessee, as well as the American Heart Association Greater Southeast Affiliate for Mission Lifeline. Cunningham holds a bachelor’s degree in nursing from the Medical University of South Carolina and a master’s degree in nursing from Austin Peay State University. More Articles by This Author »