01—Abstract
Summary
Summary of the 8-K filed May 28, 2025. Cited figures are marked; the original filing is the authoritative source.
Boston Scientific Corporation (BSX) announced on May 28, 2025, the discontinuation of worldwide sales for its ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems.
This strategic decision stems from recent regulatory discussions that have imposed significantly increased clinical and regulatory requirements for maintaining existing approvals and obtaining new ones globally. The company deemed the additional investments and resources necessary to meet these escalating demands to be prohibitive. Despite the anticipated financial impact from exiting these product lines, Boston Scientific currently expects to achieve its previously issued second quarter and full year 2025 sales and adjusted earnings per share guidance.
However, the company is not reaffirming its GAAP EPS guidance for the same periods and plans to provide further details during its second quarter 2025 earnings call. Investors should monitor upcoming communications for a clearer picture of the financial ramifications and the company's updated outlook.
02—Key points
Key Highlights
- Discontinuation of worldwide sales for ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems.
- Decision driven by prohibitive increased global regulatory and clinical requirements.
- Company anticipates achieving previously stated Q2 and Full Year 2025 reported and organic sales guidance.
- Company expects to achieve previously stated Q2 and Full Year 2025 adjusted earnings per share guidance.
- GAAP EPS guidance for Q2 and Full Year 2025 is not being reaffirmed at this time.
- Additional information on financial impacts to be provided during the Q2 2025 earnings call.
03—Questions
Frequently Asked Questions
Why is Boston Scientific discontinuing the ACURATE aortic valve systems?
Boston Scientific is discontinuing the ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems due to prohibitive increases in clinical and regulatory requirements stemming from recent discussions with global regulators. The company determined that the necessary investments to meet these escalating demands were not financially feasible.
What is the expected financial impact of this discontinuation?
While the company anticipates financial impacts from this decision, it currently expects to achieve its previously issued guidance for second quarter and full year 2025 reported and organic sales, as well as adjusted earnings per share. However, GAAP EPS guidance is not being reaffirmed, and more details are expected during the Q2 2025 earnings call.
Will this impact Boston Scientific's overall financial guidance for 2025?
The company is reaffirming its guidance for reported and organic sales and adjusted earnings per share for the second quarter and full year 2025. However, the GAAP EPS guidance is not being reaffirmed at this time. Further clarification on the financial outlook will be provided during the upcoming Q2 2025 earnings call.
What specific regulatory or clinical hurdles did the ACURATE systems face?
The filing states that recent discussions with regulators resulted in 'increased clinical and regulatory requirements to maintain regulatory approvals in global markets and to obtain approvals in new regions.' Specific details on these exact requirements were not disclosed in this 8-K filing, but the company deemed them prohibitively costly to meet.
04—Continue