Boston Scientific pulls plug on TAVR devices after failing to gain FDA approval
Boston Scientific is officially discontinuing worldwide sales of its Acurate neo2 and Acurate Prime transcatheter aortic valve replacement (TAVR) systems and no longer seeking approval from the U.S. Food and Drug Administration (FDA) or any other regulatory agencies.
The company made the news official in a filing with the U.S. Securities and Exchange Commission. It also confirmed the news in a statement to Cardiovascular Business.
“While data continue to support the performance of the Acurate valve system when the product’s optimized instructions for use are followed, this decision was made based on recent discussions with regulators, which resulted in increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets,” a representative explained. “Therefore, related commercial, clinical, research and development, and manufacturing activities will cease.”
What went wrong?
Boston Scientific, one of the world’s largest medtech companies, has been working to catch up with Medtronic and Edwards Lifesciences in the TAVR space for years now. There have been signs of momentum along the way—the Acurate Prime TAVR valve gained CE mark approval in 2024, for example—but FDA approval remained elusive.
The Acurate neo2 aortic valve system. Image courtesy of Boston Scientific.
One of the final blows to Boston Scientific’s aortic valve program seems to have been a recent clinical trial the company funded comparing the Acurate neo2 device to the Evolut TAVR platform from Medtronic and Sapien TAVR platform from Edwards Lifesciences. The data, first presented at TCT 2024 and later published in The Lancet, showed that Acurate neo2 did not meet the predetermined noninferiority margin. Patients treated with the Boston Scientific valves were associated with worse outcomes than patients treated with the Medtronic and Edwards Lifesciences valves.
At the time, co-principal investigator Michael Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist DeBakey Heart and Vascular Center, remained hopeful that there was still a path forward for the Boston Scientific technology. He and his colleagues noted that approximately 20% of the Acurate neo2 valves were not fully expanded. Had they received better training, he thought the study’s results may have been significantly different.
“Now that we recognize under-expansion, this is a correctable issue,” Reardon told Cardiovascular Business at TCT. “I’m confident that with proper procedural adjustments, the Acurate neo2 can match the performance of current leading valves.”
Ultimately, Boston Scientific was not as confident.
Medtech stocks already reflect the news
The stock market is already reacting to this announcement. In the immediate aftermath of Boston Scientific’s decision, its stock prices are down and shares for both Medtronic and Edwards Lifesciences are starting to climb. It is unclear if this will make a long-term impact on share prices or if this is just a temporary shift.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.