Imperative Care today announced US Food and Drug Administration (FDA) 510(k) clearance of its Symphony thrombectomy system to treat pulmonary embolism (PE).
This clearance expands the use of Symphony—previously for the treatment of venous thrombosis—to now include PE, providing a comprehensive solution to effectively and efficiently treat the full spectrum of venous thromboembolism (VTE) patient needs.
“Symphony introduces a new front-line 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,” said Doug Boyd, senior vice president and general manager of Imperative Care’s vascular business.
“Until now, physicians treating PE have had to choose between large-bore power and ease of use. Symphony was engineered to overcome these trade-offs by combining large-bore power with precise deep vacuum control, efficiently reducing clot burden and delivering improved speed and precision. With this expanded indication, Imperative Care is setting a new standard in PE thrombectomy care for physicians and their patients,” states Boyd.
The clearance follows the successful completion of the SYMPHONY-PE study, a pivotal investigational device exemption (IDE) trial evaluating the safety and efficacy of Symphony for the treatment of acute PE. The study was led under the oversight of the national co-principal investigators, Vivian L Bishay, associate professor in the Department of Diagnostic, Molecular and Interventional Radiology at Mount Sinai Health System in New York, USA and Sripal Bangalore, professor in the Department of Medicine at NYU Grossman School of Medicine in New York, USA.
“The study data clearly demonstrate Symphony’s safety, efficacy and efficiency, marking a significant advancement in the treatment of patients with pulmonary embolism,” said Bishay. “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.”
“In the treatment of pulmonary embolism, reducing right heart strain is of critical importance. The more rapidly we can remove thrombus and restore stable haemodynamics, the greater the benefit for patients,” said Bangalore. “Based on my initial clinical experience with the Symphony thrombectomy system, I believe it has the potential to advance clinical practice by merging large-bore continuous aspiration with the safety and precision of real-time vacuum control.”
“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,” said Fred Khosravi, chairman and chief executive officer of Imperative Care.
“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. 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.”
