AngioDynamics has concluded the enrolment of patients in the trial assessing the AlphaVac Multipurpose Mechanical Aspiration (MMA) F18⁸⁵ System for the treatment of acute intermediate-risk pulmonary embolism (PE).
PE is a life-threatening condition that impacts around 900,000 people in the US each year.
The Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) is a single-arm investigational device exemption study.
It enrolled 122 subjects with confirmed acute, intermediate-risk PE across 25 hospital-based US sites.
The reduction in RV/LV ratio between baseline and 48 hours post-procedure is the trial’s primary efficacy endpoint.
The rate of major adverse events (MAEs), including death and major bleeding related to the device within the first 48 hours, is the study’s primary safety endpoint.
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In the trial, patients will be monitored for 30 days after the procedure.
The company started the APEX-AV Study in collaboration with the Pulmonary Embolism Response Team (PERT) Consortium.
AngioDynamics clinical and scientific affairs senior vice-president Juan Carlos Serna said: “The completion of the APEX-AV Study to assess the performance of the AlphaVac F18⁸⁵ System in reducing thrombus burden and improving right ventricular function is a meaningful step toward expanding treatment options and improving care for patients with pulmonary embolism.
“We thank The PERT Consortium, including our enrolling partners, for its commitment to generating robust clinical evidence to help address the needs of this patient population.”
The AlphaVac MMA F18⁸⁵ System, an emergent first-line device, is presently approved to remove thromboembolic from the venous system.
It features an ergonomic handle, an obturator, an 18F cannula with an 85° angle and a waste bag assembly.
In August, AngioDynamics received breakthrough device designation from the US Food and Drug Administration for its AngioVac System for the non-surgical removal of right heart vegetation.
The on-circuit aspiration system utilises a venous drainage cannula to eliminate thrombi or emboli during extracorporeal bypass for up to six hours.