FDA clears first large-bore, vacuum-assisted pulmonary embolism thrombectomy system
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first large-bore continuous vacuum-assisted system to treat pulmonary embolism (PE). The Symphony Thrombectomy System from Imperative Care Inc. enables physicians to remove more clot from the lungs in less time.
“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,” explained Sripal Bangalore, MD, MHA, professor in the Department of Medicine at NYU Grossman School of Medicine in New York, in a statement. “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 FDA clearance was based on 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 Bangalore and Vivian L. Bishay, MD, associate professor in the Department of Diagnostic, Molecular and Interventional Radiology at Mount Sinai Health System 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,” Bishay said in a statement. “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.”
Symphony was previously cleared for the treatment of venous thrombosis and now for PE. The company said this allows it to be used to treat the full spectrum of venous thromboembolism (VTE) needs.
The company said that, 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.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]