Symphony delivers large-bore power with precise deep vacuum, giving physicians improved control to remove more clot in less time

Imperative Care, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Symphony^® Thrombectomy System to treat pulmonary embolism (PE), a life-threatening condition caused by blood clots blocking an artery in the lungs.

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Symphony Thrombectomy System

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 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,” said Doug Boyd, SVP 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 tradeoffs 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.”

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, Dr. Vivian L. Bishay, M.D., Associate Professor in the Department of Diagnostic, Molecular and Interventional Radiology at Mount Sinai Health System in New York, and Dr. Sripal Bangalore, M.D., M.H.A., Professor in the Department of Medicine at NYU Grossman School of Medicine in New York.

"The study data clearly demonstrate Symphony’s safety, efficacy, and efficiency, marking a significant advancement in the treatment of patients with pulmonary embolism,” said Dr. 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 hemodynamics, the greater the benefit for patients,” said Dr. 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 & CEO 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.”

About the Symphony Thrombectomy System

The Symphony Thrombectomy System is a large-bore aspiration catheter system engineered to deliver more efficient and effective clot removal for patients with venous thromboembolism (VTE). Combining large-bore power with precise deep vacuum control, Symphony empowers physicians with full control to confidently remove more clot in less time¹. The system includes 16F and 24F catheters that allow for smooth tracking and stability and can be telescoped to reach distal anatomy. By delivering deep vacuum closer to the clot, Symphony provides greater clot removal force compared to both syringe-based and tubing-based systems without increased blood loss¹. The system also includes ProHelix^® Mechanical Assist, a unique tool designed to facilitate clot ingestion when needed, the Symphony 24 Advance^® Long Dilator, designed to navigate through tortuous anatomy, and the Imperative Care Generator, the most powerful aspiration pump available on the market².

For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: http://bit.ly/3pAaUlw

About Imperative Care, Inc.

Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by devastating vascular diseases such as stroke and pulmonary embolism. The company is focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey. Imperative Care is based in Campbell, Calif. https://imperativecare.com.

¹ Data from SYMPHONY-PE IDE Study

² Data on file.

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