US-based medical technology company Imperative Care has secured the US Food and Drug Administration (FDA) 510(k) clearance for its Symphony Thrombectomy System to treat pulmonary embolism.
The FDA approval expands Symphony’s indication, which was previously limited to venous thrombosis, to address a range of venous thromboembolism patient needs.
It follows the successful SYMPHONY-PE study, which assessed the safety and efficacy of the system in treating acute pulmonary embolism.
The study was led by Dr Vivian Bishay of Mount Sinai Health System and Dr Sripal Bangalore of NYU Grossman School of Medicine.
Dr Bishay said: “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 said: “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.”
The Symphony Thrombectomy System is a large-bore aspiration catheter designed for effective clot removal in venous thromboembolism cases.
The system comprises 16F and 24F catheters for smooth tracking and stability and can be telescoped to reach distal anatomy.
It also features the ProHelix Mechanical Assist tool to facilitate clot ingestion when needed, the Symphony 24 Advance Long Dilator to navigate through tortuous anatomy, and the Imperative Care Generator, a powerful aspiration pump.
The system is designed to provide effective clot removal with minimal blood loss compared to traditional methods, including syringe-based and tubing-based systems.
Imperative Care chairman and CEO Fred Khosravi said: “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.
“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.”
In July this year, Imperative Care has received FDA approval for its Zoom 7X Catheter, which features the novel CenTRX Technology, to treat ischemic stroke.
The CenTRX Technology, with a 96° pre-shaped tip that centres within the vessel, enhances navigation and clot ingestion during aspiration thrombectomy procedures.
