Boston Sci Falls Short at TCTBoston Sci Falls Short at TCT

The Marlborough, MA-based company said results from its PROTECTED TAVR Study show its cerebral protection system failed to meet its primary endpoint.

Omar Ford

September 20, 2022

2 Min Read
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Image courtesy of Kristoffer Tripplaar / Alamy Stock Photo

Boston Scientific failed to meet the primary endpoint of reduced stroke in the PROTECTED TAVR study. The Marlborough, MA-based company presented the results of the study, which evaluated the Sentinel Cerebral Protection system last weekend at the Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium in Boston.

The device was designed to capture and remove embolic debris stemming from transcatheter aortic valve replacement (TAVR) before it can reach the brain and potentially cause a stroke.

Boston Scientific inherited Sentinel when it acquired Claret Medical in 2018 for about $220 million. This was around the time Boston Scientific was on an M&A spree.  

This randomized trial evaluated periprocedural stroke reduction and neurologic outcomes in patients with aortic stenosis treated with either the SENTINEL device to provide cerebral embolic protection (CEP) during TAVR or TAVR alone. 

The primary endpoint was not met, as the data demonstrated a non-significant trend toward a lower rate of stroke in patients treated with the SENTINEL device, representing a 21% relative risk reduction in all stroke through 72 hours or time of hospital discharge (2.3% with TAVR and CEP vs. 2.9% with TAVR only, P=0.30). 

“While this was a disappointment for investors and the interventional cardiology community alike, a secondary analysis did show a statistically significant 60% relative risk reduction in disabling stroke,” Marie Thibault, an analyst with BTIG wrote in analyst notes.

The secondary analysis showed a statistically significant 60% relative risk reduction in disabling stroke through 72 hours or time of hospital discharge in patients treated with the SENTINEL device (0.5% with TAVR and CEP vs. 1.3% with TAVR only, P=0.02).

Thibault wrote, “Following the data readout and in subsequent events, panelists and speakers debated the impact of the disabling stroke results. Some noted the findings shouldn't be ignored while others viewed it as a secondary endpoint in a negative trial. For now, we think the ambiguity of the trial isn’t likely to change clinical practice, with believers of the device continuing to use it, and those yet to adopt staying on the sidelines. When polled publicly, the physician panel discussing the results voted 7 to 1 to use Sentinel.”

She added, “Although PROTECTED TAVR missed its primary endpoint, we believe Boston Scientific can drive growth with multiple new products and expanding market opportunities.”

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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