Boston Scientific Touts 'Practice-Transforming' Trial Data for PE and AF

Executives highlight new clinical trial results at ACC conference call, describing potential impact on treatment guidelines.

Mar. 29, 2026 at 12:04am

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Boston Scientific executives highlighted data from two randomized clinical trials during an American College of Cardiology conference call, describing the results as potentially 'practice transforming' for pulmonary embolism (PE) and stroke prevention in atrial fibrillation (AF). The company discussed the HI-PEITHO trial evaluating ultrasound-assisted catheter-directed thrombolysis and the CHAMPION-AF trial comparing the WATCHMAN FLX left atrial appendage closure device with oral anticoagulation.

Why it matters

The trial results could lead to significant changes in the standard of care for treating intermediate-risk PE and managing stroke risk in non-valvular AF patients, potentially expanding the market for Boston Scientific's technologies.

The details

In HI-PEITHO, the EkoSonic system plus anticoagulation showed superiority over anticoagulation alone for a composite endpoint of PE-related death, recurrent PE, or cardiovascular decompensation. The trial also demonstrated no difference in major bleeding or intracranial hemorrhage. In CHAMPION-AF, the WATCHMAN FLX device met its primary efficacy endpoint of non-inferiority for a composite of cardiovascular death, stroke, and systemic embolism compared to oral anticoagulation. The device also demonstrated superiority for the primary safety endpoint of non-procedural bleeding.

  • The HI-PEITHO trial enrolled 544 patients across 59 sites in the U.S. and Europe.
  • The CHAMPION-AF trial involved 141 sites globally and about 300 operators.

The players

Boston Scientific

A global medical device company that develops, manufactures and markets a broad portfolio of products used in less-invasive medical procedures.

Michael Jaff

Chief Medical Officer of Vascular Therapies at Boston Scientific.

Brad Sutton

Chief Medical Officer of AF Solutions at Boston Scientific.

Marty Leon

Study co-chair and professor at Columbia University.

Ken Stein

Chief Medical Officer at Boston Scientific.

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What they’re saying

“We must not let individuals continue to damage private property in San Francisco.”

— Robert Jenkins, San Francisco resident

“Fifty years is such an accomplishment in San Francisco, especially with the way the city has changed over the years.”

— Gordon Edgar, Grocery employee

What’s next

Boston Scientific plans to submit the data to the FDA for label expansion, and the company is working with professional societies on focused consensus updates that could come before guideline changes. The company is also pursuing expanded reimbursement coverage from CMS and commercial payers.

The takeaway

The positive trial results for Boston Scientific's technologies in treating PE and managing stroke risk in AF patients could lead to significant changes in clinical practice and expand the market opportunity for the company's products. The findings highlight the potential for less-invasive, device-based approaches to transform the standard of care in these cardiovascular conditions.