Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial.

ABSTRACT:

Background

Mechanical thrombectomy offers a promising alternative to thrombolytic-based approaches for reducing thrombus burden and right heart strain in acute pulmonary embolism. This pivotal Food and Drug Administration-approval trial evaluated the safety and efficacy of the Symphony Thrombectomy System (Imperative Care, Inc, Campbell, CA) in acute intermediate-risk pulmonary embolism.

Methods

Patients with intermediate-risk pulmonary embolism (systolic blood pressure ≥90 mm Hg; right ventricle-to-left ventricle ratio >0.9) were enrolled without roll-ins. The primary safety end point was the rate of major adverse events within 48 hours, defined as a composite of all-cause major bleeding, device-related mortality, and serious device-related events, adjudicated by an academi

SUBMITTER: Bangalore S 

PROVIDER: S-EPMC12622275 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature