Boston Scientific’s TAVR Trial

Boston Scientific has been working tirelessly to compete against Edwards and Medtronic in the lucrative TAVR market for almost a decade. Its Lotus Edge Valves was approved by the FDA in April 2019, but it was discontinued soon after due to the complications in the delivery system.

Despite the setbacks, Boston Scientific directed its focus on the Acurate valves. The Acurate TAVR platform was CE Mark approved in EU and the company was progressing towards non-inferior pivotal study until the decision to discontinue with the trial due to unsatisfactory clinical performance. The Acurate TAVR was originally acquired for $435 millions in 2017.

Is that the end of Boston’s aspirations in the TAVR market?

Not advice, DYOR!

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Boston Scientific discontinues Acurate TAVR sales, cites regulatory burden

MAY 28, 2025 BY DANIELLE KIRSH

Boston Scientific has discontinued global sales of its Acurate neo2 and Acurate Prime transcatheter aortic valve replacement (TAVR) systems and will no longer pursue regulatory approval for the devices.

The decision follows recent discussions with regulators in the U.S. and Europe, which led to heightened clinical and regulatory requirements. Boston Scientific said the additional resources required to meet those demands were “prohibitive” and not justified by the potential returns.

The Accurate TAVR systems had been Boston Scientific’s next bet to compete against Edwards Lifesciences and Medtronic in the space after the discontinuation of its Lotus TAVR program five years ago.

The Minnesota Star Tribune — which covers a state where Boston Scientific has a significant presence — reports that the Accurate TAVR discontinuation will result in job cuts, though the company did not disclose how many.

Despite the move, the company said it expects to meet its previously issued guidance for the second quarter and full-year reported and organic sales, as well as adjusted earnings per share. However, it is not reaffirming its GAAP earnings guidance at this time and will provide further updates during its next quarterly earnings call.

The announcement comes less than a week after new clinical trial data showed that the Acurate neo2 device failed to meet its primary non-inferiority endpoint in a head-to-head trial with Medtronic’s CoreValve Evolut platform. The results, presented at the TCT conference in late 2024, raised concerns about the product’s competitive viability.

Meanwhile, real-world registry data recently published suggested that the Acurate Prime valve demonstrated acceptable outcomes in high-volume European centers, indicating that the device may have maintained clinical value in certain contexts.

Boston Scientific originally acquired the Acurate TAVR platform through its 2017 acquisition of Switzerland-based Symetis for $435 million. The company has not indicated whether it plans to re-enter the TAVR space with alternative technologies.

Analyst sees continued strength in Boston Scientific portfolio

In a note to investors, Mike Matson, senior research analyst at Needham & Company, said the company generated approximately $200 million in sales from Acurate devices in 2024 but noted that sales were likely declining following the clinical trial results.

“BSX noted that the decision was driven by recent discussions with U.S. and European regulators, and management felt that the increased clinical evidence and regulatory hurdles needed to maintain product approvals globally for Acurate would not be worth the investment,” Matson said.

Matson characterized any short-term weakness in Boston Scientific shares as a buying opportunity, citing continued strength in the company’s broader portfolio and the potential for the Champion trial, expected in the first half of 2026, to expand indications and reimbursement for the Watchman left atrial appendage (LAA) closure device that complements cardiac procedures such as pulsed-field ablation.

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