The FDA IDE study evaluates the company’s Symphony Thrombectomy System for treating acute pulmonary embolism (PE). Designed to expand Symphony’s current indication for use to include PE, investigators conducted the study across 19 U.S. centers.
Imperative Care designed Symphony to deliver consistent, seamless clot removal in one fully integrated solution. It features purpose-built catheters that optimize navigation and positioning for precise placement. The system’s controller maximizes clot removal through high-powered, on-demand, continuous aspiration while minimizing blood loss.
Symphony also features a mechanical assist component for engaging and disrupting clots, while its proximal and distal coil design provides flexibility and trackability.
Dr. Vivian L. Bishay and Dr. Sripal Bangalore serve as national co-principal investigators of the SYMPHONY-PE study. Bishay says the study represents a promising step forward in evaluating next-generation technology.” Bangalore outlined how early clinical use of Symphony demonstrated “promising potential” for clot removal for PE.
Dr. Dana Tomalty serves as a site investigator in Alabama. Tomalty said the study could deliver insight into Symphony’s “potential to transform the treatment of patients with PE.”
Investigators expect to share topline results from the study this year.
“At Imperative Care, our mission to elevate thrombectomy care is rooted in a commitment to validating our innovations with robust clinical data to ensure we are engineering solutions that make a measurable impact on patient outcomes,” said Fred Khosravi, CEO of Imperative Care. “We greatly appreciate the investigators, clinical sites, and patients who have participated in this trial.”
