FDA Approves 2 New TAVR Systems for High-Risk, Inoperable Patients

The number and quality of TAVR devices available to US clinicians is growing, as demonstrated by the recent approvals of the Sapien 3 transcatheter heart valve and the CoreValve Evolut R.

With results lauded as the lowest adverse event rates achieved after balloon-expandable TAVR—specifically, 2.2% all-cause mortality and 1.5% stroke—the Sapien 3 transcatheter heart valve (Edwards Lifesciences) was cleared by the FDA on June 17, 2015, for use in patients with aortic stenosis who are deemed high-risk or inoperable.

Next Step: FDA Approves 2 New TAVR Systems for High-Risk, Inoperable Patients

The device is the third generation of the valve from the manufacturer; the first was approved by the FDA in 2011. The main design changes include the addition of a skirt at the base of the valve intended to minimize paravalvular leak.

“It’s what we were waiting for,” said Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), in a telephone interview with TCTMD. “This is a truly matured device with features to address many issues from the past, like vascular complications and paravalvular leak, so that's really exciting.”

In an email with TCTMD, Isaac George, MD, also of Columbia University Medical Center, said that the speed with which the device was approved “is testimony to the data. We are seeing quicker and quicker approval times from the FDA, and appropriately so, as we transition from first-generation, unknown devices to well-studied, advanced valves with a huge US experience. With that body of knowledge and with iterative advancements, I think TAVR will continue to benefit from faster approval times.”

Similarly, Peter C. Block, MD, of Emory University Hospital (Atlanta, GA), told TCTMD in an email that “the speed of approval was a surprise, but considering the ease of use of the device, the outcomes, and the improvements over earlier Edwards devices (especially in terms of incidence of [paravalvular leak]), the speed was welcomed.”

Repositioning Now an Option

The FDA also approved today the latest self-expanding valve iteration from Medtronic—the CoreValve Evolut R—for use in patients at extreme or high risk for surgery. This device is the first fully recapturable and repositionable device available in the United States and features a nitinol-reinforced capsule with flare to provide the structural support needed to resheath and reposition the valve.

In results presented at EuroPCR 2015 last month, VARC-2 device success was obtained in 78.6% of patients treated with Evolut R, including freedom from patient prosthesis mismatch in 83.6% and no periprocedural mortality. Mild or moderate paravalvular regurgitation was observed in 42.6% of patients, with no cases of severe leak at 6 months. Repositioning was required 22 times in 15 patients.

“Clinical data have shown the best patient outcomes are achieved when the valve is properly positioned,” said Mathew Williams, MD, of the NYU Langone Medical Center (New York, NY), in a press release. “The advancement of recapturability with Evolut R gives physicians more confidence during the procedure and provides advantages that are nonexistent in other TAVR systems.”

Expanding the Toolbox

Since the indications for Sapien 3 use are “still limited,” Dr. Block said, “the toolbox will be expanded but not emptied (yet). However, I feel that Sapien 3 will ultimately supplant all the other technologies that Edwards currently has in place.”

Dr. George said the availability of Sapien 3 will allow treatment of patients with smaller vessels. Additionally, features like the skirt and positioning knob “make the procedure reproducible and with excellent results. This will allow the older generations [of balloon-expandable valves] to be removed from the shelf, as [they] offer no advantage over the Sapien 3.”

Both Sapien 3 and CoreValve Evolut R “are setting the standard for ease of use, valve performance, and delivery,” he continued. “Each offers its own advantages and disadvantages, so it is incumbent on the experienced operator to know when to use each. As the field evolves, I think we will see more and more valves that are designed to work in specific situations or anatomies.”

According to Dr. Block, certain cath labs are dedicated to one or the other manufacturer and that likely will not change. “Sheath sizes are now pretty much comparable, and both devices are user-friendly to the operator and the patient,” he observed. “Operators will still have patients that are perhaps better suited to one device or another depending on anatomic issues, annular size, aortic size, etc.”

Remaining Issues to Settle

Sapien 3 vastly reduces stroke rates over prior generations—partially attributable to the lower-risk patient group now being treated—but Dr. Généreux said future iterations will need to focus on postprocedure pacemaker need. Pacemaker need with the Sapien XT device was in the 4%-5% range compared to about 20% with the original CoreValve system. “Now, with Sapien 3, the prosthesis is a little bit longer so the pacemaker rate is about 8%-10%,” he reported. “Maybe we have a little more to learn about how to position the prosthesis…. We need to decrease to the single digits, but I think it will come.”

Dr. Block highlighted the uncertainty about the long-term consequences of any paravalvular leak before asserting that “medical therapy for degenerative aortic disease is still the holy grail and will likely (if ultimately successful) make all this transcatheter therapy moot.”

Lastly, Dr. George said valve durability is “the most important factor that will drive TAVR technology into lower-risk populations, so we are eagerly awaiting long-term outcomes. A key area of research will be how to prolong the life of the valve leaflets and prevent valve calcification, which is an area that has been overlooked.”


1. FDA approves SAPIEN 3 THV artificial heart valve: third generation of valve contains design change to minimize leakage [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451678.htm. Published June 17, 2015. Accessed June 23, 2015.
2. Medtronic announces FDA approval for new TAVR system, introduces first and only recapturable heart valve in U.S. [press release]. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2061818. Published June 23, 2015. Accessed June 23, 2015.


  • Dr. Généreux reports receiving speaker and consulting fees from Edwards Lifesciences.
  • Dr. Block reports participating at an Edwards research site and holding equity in Direct Flow Medical.
  • Dr. George reports no relevant conflicts of interest.

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