Sapien XT Given Go-Ahead to Make US Debut
Mere days after the US Food and Drug Administration (FDA) expanded approval of the CoreValve device for transcatheter aortic valve replacement (TAVR) in patients at high risk, the agency approved use of the Sapien XT in inoperable patients on June 16, 2014.
Sapien XT (Edwards Lifesciences; Irvine, CA) is the next iteration of the Sapien valve, which was FDA approved in November 2011. Data from the randomized PARTNER II trial, presented at the 2013 American College of Cardiology/i2 Scientific Session, showed similar efficacy and safety between the 2 generations but fewer complications with the newer device.
A Major Advance but US Market Still Lags
According to Ted Feldman, MD, of Evanston Hospital (Evanston, IL), Sapien XT offers a number of advantages over its predecessor.
“This is a major advance in terms of much lower profile femoral access sheaths,” he told TCTMD in an email. Operators “will appreciate that a greater proportion of patients can [now] have femoral rather than apical/alternate access TAVR,” he said. “Puncture management and closure are easier, and vascular complications are decreased.”
In addition, Sapien was available in only 2 sizes—23 and 26 mm—whereas Sapien XT will come in 29 mm as well.
Dr. Feldman stressed, however, that the approval would not bring the United States up to speed with Europe, where Sapien XT has been commercially available since 2010. “There are several platforms available in Europe that have additional advantages,” he said, citing Sapien 3 (Edwards Lifesciences) as well as the Lotus valve (Boston Scientific; Natick, MA) and devices made by Direct Flow Medical (Paris, France) and JenaValve (Munich, Germany). Both the Direct Flow registry of extreme-risk patients and the Lotus randomized trial in extreme/high-risk patients are forthcoming, Dr. Feldman reported.
FDA Blog Post Muddies the Waters
In a blog post published the day of Sapien XT’s approval on the FDA website, Jeffrey Shuren, MD, JD, Director of the Center for Devices and Radiological Health, stressed the importance of expanding patient access to TAVR.
The Sapien XT decision was informed by data from a number of sources beyond PARTNER II, he emphasized, including single-arm nested US registries, the European SOURCE XT registry, the Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy registry, and peer-reviewed articles.
Yet FDA approval came, Dr. Shuren said, “despite observing certain quality system violations during a recent inspection at the Edwards manufacturing facility where the Sapien XT delivery systems and accessories are made…. When violations occur, according to federal law, we cannot approve a company’s medical device—unless, we allow deviation from quality system requirements through what is known as a ‘variance.’”
In this case, a variance was granted to Edwards Lifesciences for 2 reasons, he continued.
“First, we determined that there is an important, immediate need for these technology options and that Sapien XT demonstrates a reasonable assurance of safety and effectiveness for its intended use. This means patients who really need this technology could and should receive it,” Dr. Shuren explained. “And second, Edwards Lifesciences presented us with an appropriate variance plan for addressing its manufacturing problems—including specific controls to permit safe use of the Sapien XT while corrections are underway.”
Dr. Feldman, too, seemed reassured. “It appears that the XT device and delivery system are not an issue, and the FDA felt a waiver for the plant concerns was warranted,” he said.
Sources:
1. Edwards Lifesciences launching Sapien XT valve in the US
[press release]. http://www.edwards.com/newsroom/Pages/NR20140616.aspx.
Published June 16, 2014. Accessed June 17, 2014.
2. Shuren J. Life-saving, smart regulation on behalf of
patients with aortic stenosis [blog]. http://blogs.fda.gov/fdavoice/index.php/2014/06/
life-saving-smart-regulation-on-behalf-of-patients-with-aortic-stenosis/.
Published June 16, 2014. Accessed June 17, 2014.
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Caitlin E. Cox is News Editor of TCTMD and Associate Director, Editorial Content at the Cardiovascular Research Foundation. She produces the…
Read Full BioDisclosures
- Dr. Feldman reports serving as a consultant to Boston Scientific, Edwards Lifesciences, and JenaValve.
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