Imperative Care today announced the completion of patient enrolment in its SYMPHONY-PE study, a pivotal investigational device exemption (IDE) trial evaluating the safety and efficacy of the company’s Symphony thrombectomy system for the treatment of acute pulmonary embolism (PE).
Designed to expand Symphony’s current indication for use to include PE, the study was conducted at 19 leading interventional radiology, interventional cardiology and vascular surgery centres across the USA.
“While progress has been made in the treatment of pulmonary embolism, there is still a need for therapies that may offer improvements in safety, efficiency and long-term patient outcomes,” said interventional radiologist, Vivian L Bishay (Mount Sinai Health System, New York, USA) and national co-principal investigator of the SYMPHONY-PE study. “This study represents a promising step forward in evaluating next generation technology to expand treatment options for physicians and their patients.”
“Early clinical use of Symphony—including both 16Fr and 24Fr catheters—has shown promising potential for fast, safe and efficient clot removal for PE utilising powerful precision thrombectomy,” said Sripal Bangalore (NYU Grossman School of Medicine, New York, USA) and national co-principal investigator of the SYMPHONY-PE study. “We thank the patients, investigators, and clinical research teams whose efforts were instrumental in helping us complete enrolment. We look forward to sharing topline results later this year.”
“Initial experience with the novel Symphony thrombectomy system at our centre has been promising,” said Dana Tomalty, peripheral and neuro interventional radiologist at Huntsville Hospital in Alabama, USA and the site principal investigator. “I believe the study data may offer further insight into Symphony’s potential to transform the treatment of patients with PE.”
“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, chief executive officer of Imperative Care. “Symphony is a critically important technology that is poised to transform treatment for patients with devastating pulmonary embolisms, a major cause of global morbidity and mortality. We greatly appreciate the investigators, clinical sites, and patients who have participated in this trial.”
