Imperative Care’s SYMPHONY-PE IDE Study Completes Enrollment

May 13, 2025—Imperative Care, Inc announced the completion of patient enrollment in its SYMPHONY-PE study, which was conducted at 19 interventional radiology, interventional cardiology, and vascular surgery centers across the United States.

According to Imperative Care, the pivotal investigational device exemption (IDE) trial is evaluating the safety and efficacy of the company’s Symphony thrombectomy system for the treatment of acute pulmonary embolism (PE).

The study was designed to expand Symphony’s current indication for use to include PE. The device is currently indicated for the treatment of venous thrombosis, noted the company’s press release.

Vivian L. Bishay, MD, and Sripal Bangalore, MD, serve as national coprincipal investigators of the SYMPHONY-PE study.

“While progress has been made in the treatment of PE, there is still a need for therapies that may offer improvements in safety, efficiency, and long-term patient outcomes,” commented Dr. Bishay in Imperative Care’s press release. “This study represents a promising step forward in evaluating next-generation technology to expand treatment options for physicians and their patients.” Dr. Bishay is Associate Professor in the Department of Diagnostic, Molecular and Interventional Radiology at Mount Sinai Health System in New York, New York.

Dr. Bangalore added, “Early clinical use of Symphony—including both 16-F and 24-F catheters—has shown promising potential for fast, safe, and efficient clot removal for PE utilizing powerful precision thrombectomy. We thank the patients, investigators, and clinical research teams whose efforts were instrumental in helping us complete enrollment. We look forward to sharing topline results later this year.” Dr. Bangalore is Professor in the Department of Medicine at NYU Grossman School of Medicine in New York, New York.

Dana Tomalty, MD, who is a peripheral and neuro interventional radiologist at Huntsville Hospital in Huntsville, Alabama, and serves as a site principal investigator for the study, stated in the press release, “Initial experience with the novel Symphony thrombectomy system at our center has been promising. I believe the study data may offer further insight into Symphony’s potential to transform the treatment of patients with PE.”