FDA approves first large-bore continuous vacuum suction cat

Imperative CareAnnouncing its suction catheter---SymphonyApproved by the FDA for marketing, it is used to treat pulmonary embolism (PE). This approval alsoSymphonyIndications fromVenous thrombosis extendsPulmonary embolism, which mayProviding a comprehensive treatment plan for patients with venous thromboembolism (VTE

SymphonyQuick approval for IDE-based clinicalSYMPHONY-PE), this study confirmsSymphonySafety and Efficacy in the Treatment of Acute Pulmonary Embolism.

PI

“The study data clearly demonstrate the safety, efficacy, and efficiency of Symphony, marking a significant advancement in the treatment of pulmonary embolism. This achievement highlights Symphony’s potential to address critical unmet medical needs by enabling rapid and controllable thrombus removal while maintaining an excellent safety profile. I look forward to applying this important new technology in clinical practice to improve outcomes for patients with life-threatening pulmonary

---Vivian L. Bishay  Mount Sinai Health System 

"Relieving right heart strain is crucial in the treatment of pulmonary embolism. The faster thrombus removal and hemodynamic stability are achieved, the greater the benefit for patients. Based on initial clinical experience with the Symphony system, I believe its combination of large-bore continuous aspiration with the safety and precision of real-time vacuum control holds promise for advancing clinical practice."

---Sripal Bangalore  NYU Grossman School of Medicine 

Executive

Fred Kothrow, Chairman and CEO of the company, stated: "Vena Medical's innovation begins with identifying the most critical issues in patient care and enhancing long-term patient outcomes through engineering. Pulmonary embolism can cause irreversible and devastating damage to patients within minutes. We are committed to revolutionizing the treatment of thromboembolic diseases, providing doctors with safer, more convenient, and efficient thrombus removal technologies. This achievement would not have been possible without the selfless participation of patients and their families in key trials. We also extend our deepest gratitude to the research team for their tireless dedication, which has ultimately brought this new therapy to benefit patients with pulmonary

---Fred Khosravi   Chairman and Chief Executive Officer of Imperative Care

"Symphony introduces a groundbreaking frontier in pulmonary embolism treatment, empowering physicians with full control throughout the procedure to clear more clots in less time and deliver superior patient care. Previously, physicians had to compromise between large-bore suction and operational ease, but Symphony combines substantial suction power with precise vacuum depth control to effectively reduce thrombotic burden while enhancing procedural speed and accuracy. With this expanded indication, Beian Medical is establishing a new standard for pulmonary embolism thrombectomy for both healthcare providers and patients

----Doug Boyd  Imperative CareSenior Vice President and General Manager,

Symphony

SymphonyIt mainly consists of three parts: the catheter, the control handle,ProHelix mechanical assist

• Cat

24F Catheter: Proximal and distal coil design enhances catheter flexibility and track

16F Catheter: 75° angled tip design for directional

• Control Handle

• ProHelix Mechanical Assist