Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F18 PE for Treatment of Acute Pulmonary Embolism (APEX-AV)
ClinicalTrials.gov
Who Can Join the Study?
Study Objective
The APEX-AV study is researching whether the AlphaVac MMA F18 PE System is safe and effective for treating acute intermediate-risk pulmonary embolism.
The APEX-AV study is for people 18 and older who have been diagnosed with acute pulmonary embolism in the last 14 days.
Electronic I/E Checklist
Printable I/E Checklist
For more information, contact ApexAV@angiodynamics.com
RISK INFORMATION STATEMENT
The AlphaVac MMA F18 PE System is an investigational medical device designed to remove blood clots from the lungs. It is considered investigational because it has not been cleared by the FDA for treatment of PE outside of this clinical research study.
CONTRAINDICATIONS:
The following contraindications are applicable:
• The device is contraindicated in the removal of chronic firmly adherent intravascular material.
• The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation.
• The device is contraindicated for blood storage and infusion back into the patient
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
Refer to product Directions for Use for full details pertaining to risks, warnings, precautions, and other device safety information.
AngioDynamics, and the AngioDynamics logo, AlphaVac, and the AlphaVac logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. All other trademarks are property of their respective owners. © 2022 AngioDynamics, Inc. US/VI/WP/1517 Rev 01 09/2022
What is the AlphaVac MMA F18 PE System?
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The AlphaVac MMA F18 PE System is an investigational medical device
designed to remove blood clots from the lungs.
Alpha-Vac.com
AngioDynamics.com
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The PERT Consortium™ is pleased to be partnering
with AngioDynamics, Inc. on the APEX-AV study.
PERTconsortium.org