Imperative Care Secures FDA Clearance for Symphony Thrombectomy System, Expanding Use to Pulmonary Embolism Treatment
Imperative Care, Inc., a medical technology company focused on advancing solutions for vascular and neurovascular conditions, has received a key regulatory milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its Symphony® Thrombectomy System to treat pulmonary embolism (PE). The clearance significantly broadens the system’s clinical utility, enabling physicians to address one of the most dangerous cardiovascular emergencies with a device that combines high-power aspiration with fine-tuned vacuum control.
Expanding Indications for Symphony
The Symphony system was originally cleared for the treatment of venous thrombosis, which occurs when blood clots form in the deep veins of the body, particularly in the legs. With this latest FDA clearance, Symphony’s reach now extends to pulmonary embolism—a condition where blood clots travel to the lungs and obstruct pulmonary arteries, often leading to life-threatening complications.
This expansion positions Symphony as a comprehensive thrombectomy solution for the full spectrum of venous thromboembolism (VTE) conditions, which include both deep vein thrombosis (DVT) and pulmonary embolism. VTE is recognized as one of the most serious and common vascular disorders, affecting hundreds of thousands of patients annually in the United States alone. By offering physicians a tool to address both ends of the spectrum, Imperative Care is establishing Symphony as a frontline device in interventional treatment.
A New Approach to Pulmonary Embolism Care
Doug Boyd, Senior Vice President and General Manager of Imperative Care’s vascular business, emphasized the transformational nature of the system in pulmonary embolism care. “Symphony introduces a new frontline approach to PE treatment that gives physicians full control over the procedure, allowing them to remove more clot in less time and to provide better care for their patients,” he said.
Boyd highlighted the engineering challenges that have historically confronted physicians treating pulmonary embolism. Until now, interventionalists have often been forced to choose between large-bore power—devices capable of aspirating significant clot volumes quickly—and ease of use, which can be compromised when maneuvering large catheters. Symphony was specifically engineered to resolve these trade-offs, pairing large-bore aspiration power with advanced real-time vacuum control.
This design allows physicians not only to efficiently reduce clot burden but also to maintain procedural precision and safety. According to Boyd, Symphony’s unique technology is setting “a new standard in PE thrombectomy care” by merging speed, control, and physician-friendly usability.
Evidence from the SYMPHONY-PE Study
The FDA’s decision was supported by results from the pivotal SYMPHONY-PE Study, a prospective Investigational Device Exemption (IDE) trial conducted to evaluate the safety and effectiveness of the Symphony Thrombectomy System for acute pulmonary embolism patients.
The study was co-led by National Principal Investigators Dr. Vivian L. Bishay, M.D., Associate Professor in the Department of Diagnostic, Molecular and Interventional Radiology at Mount Sinai Health System, and Dr. Sripal Bangalore, M.D., M.H.A., Professor in the Department of Medicine at NYU Grossman School of Medicine.
Dr. Bishay underscored the significance of the findings, noting: “The study data clearly demonstrate Symphony’s safety, efficacy, and efficiency, marking a significant advancement in the treatment of patients with pulmonary embolism. These results underscore Symphony’s potential to address a critical unmet need by enabling rapid, controlled clot removal while maintaining a strong safety profile. I look forward to incorporating this important new technology into my practice to improve care for patients facing this life-threatening condition.”
Dr. Bangalore echoed these sentiments, emphasizing the critical role of reducing right heart strain in PE management. “In the treatment of pulmonary embolism, reducing right heart strain is of critical importance. The more rapidly we can remove thrombus and restore stable hemodynamics, the greater the benefit for patients,” he explained. Drawing from his initial clinical experience with Symphony, Dr. Bangalore described the device as a potential leap forward, bringing together “large-bore continuous aspiration with the safety and precision of real-time vacuum control.”
A Patient-Centered Approach to Innovation
For Imperative Care, Symphony’s expanded clearance reflects a broader innovation philosophy centered on identifying the most urgent gaps in patient care and engineering solutions that can meaningfully improve outcomes.
Fred Khosravi, Chairman and CEO of Imperative Care, articulated this mission clearly: “At Imperative Care, our approach to innovation begins by identifying the most impactful problems in patient care and engineering solutions that elevate long-term outcomes of patients. Pulmonary embolism can have a devastating impact on patients’ lives, irreversibly and within minutes. We remain fully committed to transforming the treatment of thrombo-embolic diseases for patients and providing physicians with technologies that make clot removal safer, easier and more effective.”
Khosravi also expressed gratitude toward the patients, families, and investigators involved in the pivotal trial. “This achievement would not have been possible without the patients and their families who selflessly participated in the pivotal trial, and we are deeply grateful to the investigators and research teams whose tireless dedication turned the vision of this new therapy into a reality for patients with pulmonary embolism,” he said.
Addressing an Urgent Clinical Need
Pulmonary embolism represents one of the most urgent challenges in cardiovascular care. PE occurs when a blood clot, typically originating in the deep veins of the legs, travels to the lungs and obstructs blood flow. Depending on the size and location of the clot, PE can cause symptoms ranging from shortness of breath and chest pain to sudden cardiovascular collapse. The condition is associated with significant mortality, particularly in cases of massive or submassive PE where right heart strain is present.
Traditional treatment options have included anticoagulation, systemic thrombolysis, and catheter-directed therapies. However, each approach carries limitations. Anticoagulation prevents clot progression but does not actively remove existing thrombus. Thrombolytic drugs can dissolve clots but are associated with a high risk of bleeding. Existing catheter-based thrombectomy devices have offered solutions but often required physicians to compromise between clot removal power and device navigability.
By combining continuous large-bore aspiration with finely tuned vacuum control, Symphony aims to address these limitations directly. The device is designed to remove thrombus rapidly while minimizing the risks of vessel injury, incomplete aspiration, or hemodynamic instability. This dual emphasis on speed and safety reflects the urgent needs of PE patients and the complex decision-making physicians face in acute settings.
