$Boston Scientific (BSX.US)$ NEWS MODULAR ATP Study of the m...
NEWS
MODULAR ATP Study of the mCRM™ System Meets Primary Safety and Efficacy Endpoints
Positive
MODULAR ATP study met all safety and efficacy endpoints.
Major complication-free rate of 97.5% for EMPOWER LP.
Communication success rate of 98.8% between EMBLEM S-ICD and EMPOWER LP.
ATP success rate of 61.3% with no patient therapy deactivations due to discomfort.
Pacing capture thresholds met in 97.4% of patients.
Positive clinical performance suggests a potential upgrade pathway for patients needing ATP or pacing.
Data indicates physicians can tailor therapy to patient needs, reducing the risks of more invasive procedures.
FDA approval of the mCRM System anticipated in 2025.
Negative
APPRAISE ATP trial showed only a small absolute reduction in first all-cause shocks (1% per year).
Shock burden was not significantly different between trial arms.
The vast majority of patients in the ATP-plus-shock arm did not require ATP therapy.
EMPOWER LP is still an investigational device, not available for sale or in the European Economic Area.
MODULAR ATP study met all safety and efficacy endpoints.
Major complication-free rate of 97.5% for EMPOWER LP.
Communication success rate of 98.8% between EMBLEM S-ICD and EMPOWER LP.
ATP success rate of 61.3% with no patient therapy deactivations due to discomfort.
Pacing capture thresholds met in 97.4% of patients.
Positive clinical performance suggests a potential upgrade pathway for patients needing ATP or pacing.
Data indicates physicians can tailor therapy to patient needs, reducing the risks of more invasive procedures.
FDA approval of the mCRM System anticipated in 2025.
Negative
APPRAISE ATP trial showed only a small absolute reduction in first all-cause shocks (1% per year).
Shock burden was not significantly different between trial arms.
The vast majority of patients in the ATP-plus-shock arm did not require ATP therapy.
EMPOWER LP is still an investigational device, not available for sale or in the European Economic Area.
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