RT’s Three Key Takeaways
- The AlphaVac F1885 System acquired FDA clearance for the therapy of pulmonary embolism, increasing indications for the system.
- The APEX-AV examine, which enrolled 122 sufferers throughout 25 US websites, demonstrated the system’s effectiveness in lowering thrombus burden and bettering proper ventricular operate.
- Outcomes from the APEX-AV examine confirmed a major lower in RV/LV ratio and a low price of main hostile occasions, highlighting the system’s security and efficacy in pulmonary embolism therapy.
AngioDynamics Inc introduced that the US Meals and Drug Administration (FDA) has cleared the AlphaVac F1885 System for the therapy of pulmonary embolism (PE), enhancing its utility in important medical situations reminiscent of PE.
The expanded FDA indication permits for the utilization of the AlphaVac F1885 System for the therapy of PE, which broadens the applicability of the AlphaVac F1885 System within the non-surgical removing of thrombi or emboli from the venous vasculature. The indication expands therapy choices for sufferers with PE, lowering thrombus burden and bettering proper ventricular operate.
APEX-AV Research Completion
In December 2023, AngioDynamics introduced the completion of affected person enrollment in its acute pulmonary embolism extraction trial with the AlphaVac System (APEX-AV) examine, a single-arm Investigational Gadget Exemption examine that enrolled 122 sufferers with confirmed acute, intermediate-risk PE throughout 25 hospital-based websites in the US to evaluate the AlphaVac F1885 System for the therapy of PE.
The APEX-AV examine was initiated in partnership with the Pulmonary Embolism Response Workforce (PERT) Consortium and led by co-principal investigators William Brent Keeling, MD, affiliate professor of surgical procedure within the division of surgical procedure on the Emory College Faculty of Medication and quick previous president of the PERT Consortium, and Mona Ranade, MD, assistant professor of interventional radiology on the David Geffen Faculty of Medication at UCLA.
Key Findings and Endorsements
“The addition of the AlphaVac System within the mechanical thrombectomy world is a important step ahead within the therapy of PE sufferers,” says Keeling in a launch. “The speedy affected person enrollment and the superb security and efficacy outcomes from the APEX-AV examine validate the necessity for such applied sciences to be a part of the PE therapy algorithm.”
The first efficacy endpoint of the APEX-AV examine was the discount in RV/LV ratio between baseline and 48 hours post-procedure. The first security endpoint was the speed of main hostile occasions (MAEs), together with occasions reminiscent of main bleeding and critical device-related scientific deterioration, pulmonary vascular damage, and cardiac damage, inside the first 48 hours. Sufferers have been adopted for 30 days post-index process.
Medical Impression and Future Instructions
“The 510(ok) clearance of the AlphaVac System represents an vital milestone in direction of the therapy of PE,” says Ranade in a launch. “The information from the APEX-AV examine confirmed a major enchancment within the RV operate and a speedy decision of clot burden within the pulmonary arteries.”
The APEX-AV examine confirmed a imply lower within the RV/LV ratio from baseline to 48 hours post-procedure of 0.45 (considerably better than the pre-defined efficiency purpose of 0.12 (p < 0.001)) and a MAEs price of 4.1% (considerably decrease than the pre-defined efficiency purpose of 25% (p < 0.001)). The examine additionally confirmed a 35.5% imply discount in clot burden from baseline to 48 hours post-procedure.
“Catheter-based therapies have gotten a significant device within the PE area,” says John M. Moriarty, MD, president-elect of the PERT Consortium and professor of interventional radiology at UCLA, in a launch. “With a deal with that may restrict blood loss and a real massive bore cannula with a 33 Fr funnel, I count on the AlphaVac System to play a vital function within the therapy of PE.”
The AlphaVac F1885 System is an emergent first-line gadget that’s at the moment cleared for the removing of thromboemboli from the venous system and for the therapy of PE. The system consists of an ergonomic deal with, an 18F cannula with an 85-degree angle, an obturator, and a waste bag meeting. The APEX-AV examine was designed to offer security and efficacy knowledge for a clearance particular to PE.
Picture caption: AlphaVac F1885 System
Picture credit score: AngioDynamics Inc
