Imperative Care wins FDA Clearance for device to treat pulmonary embolism

Symphony Thrombectomy system: ©Imperative Care

Imperative Care Inc. said it has received U.S. Food and Drug Administration clearance to market its Symphony Thrombectomy System for the treatment of pulmonary embolism, a potentially fatal condition caused by blood clots blocking arteries in the lungs.

The FDA’s 510(k) clearance expands the use of Symphony, which had previously been approved for venous thrombosis, to include pulmonary embolism. The company said the device offers physicians greater control during procedures, allowing them to remove more clot in less time while minimizing risks.

“Symphony introduces a new frontline approach to PE treatment that gives physicians full control over the procedure,” said Doug Boyd, senior vice president and general manager of Imperative Care’s vascular business. “Symphony was engineered to overcome tradeoffs by combining large-bore power with precise deep vacuum control.”

The clearance follows results from the SYMPHONY-PE Study, a pivotal trial conducted under an Investigational Device Exemption. The study was co-led by Vivian L. Bishay of Mount Sinai Health System and Sripal Bangalore of NYU Grossman School of Medicine, who both said the data demonstrated Symphony’s safety and effectiveness in reducing clot burden while supporting rapid recovery.

Fred Khosravi, chairman and CEO of Imperative Care, said the company is focused on solving urgent problems in patient care. “Pulmonary embolism can have a devastating impact on patients’ lives, irreversibly and within minutes,” he said.

Advances in pulmonary embolism treatment

The FDA’s decision comes amid a broader wave of innovation in treating pulmonary embolism (PE), a condition that affects an estimated 900,000 people in the United States each year, according to the Centers for Disease Control and Prevention. Roughly one-third of patients with PE die within a month of diagnosis, underscoring the urgency for new solutions.

Traditionally, PE treatment has relied on anticoagulant drugs, which prevent further clotting but do not actively remove existing clots. In severe cases, systemic thrombolytic therapy—clot-dissolving medication delivered intravenously—has been used, but it carries significant bleeding risks. Over the past decade, interventional devices such as catheters and thrombectomy systems have emerged as alternatives, giving physicians more targeted ways to physically remove clots while minimizing complications.

Recent clinical studies have highlighted the potential of catheter-directed therapies, which deliver clot-busting medication directly to the blockage site, allowing for lower doses and reduced risk. Mechanical thrombectomy systems like Symphony represent another leap forward by physically aspirating or fragmenting clots, often in a single procedure. Early evidence suggests these devices can reduce strain on the right side of the heart more quickly than drug-based approaches, which may lead to shorter hospital stays and improved survival rates.

Beyond procedural advances, there is also growing attention on risk stratification—identifying which PE patients are at highest risk and require aggressive intervention. Artificial intelligence and advanced imaging are beginning to play a role in this process, helping clinicians decide between conservative medical therapy and invasive clot removal.

Together, these developments are reshaping the landscape of PE care. Where once treatment was limited to anticoagulation and high-risk systemic therapy, physicians now have an expanding toolkit of targeted, minimally invasive options. As more data from large-scale trials become available, experts say the field is likely to move toward earlier intervention and individualized treatment strategies, potentially improving outcomes for thousands of patients each year.