The investigation is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA F1885 System for the treatment of acute pulmonary embolism.
Provision of signed and dated informed consent form.
Subject is 18 years of age and older.
Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).
Subjects who are or may be pregnant as determined by a positive pregnancy test or who are breastfeeding.
Subjects who have any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
Subjects who have used thrombolytics in the 30 days prior to the baseline CTA.
Subjects who have pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg.
Single group
AlphaReturn Blood Management System
DeviceThe AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.
Rate of Device-Related Adverse Events (AEs)
The number and proportion of subjects who experienced at least one device-related adverse event. This will be summarized, and the 95% confidence interval of the proportion will be presented. The incidence of device-related adverse events by type and seriousness through 30 days will also be summarized.
Rate of Technical Success
Successful autologous blood transfusion using the AlphaReturn Blood Management System
Rate of Major Adverse Events (MAEs)
The rate of MAEs within the first 48 hours after the index procedure. MAEs include device-related death, major bleeding, and device-related SAEs of clinical deterioration, pulmonary vascular injury, and cardiac injury.
Rate of Complications
Rate of complications including device-related clinical deterioration, device-related cardiac injury, device-related pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.
Rate of Device-Related SAEs
Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post procedure.
Rate of Symptomatic PE recurrence within 30 days
Symptomatic PE recurrence within 30 days.
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