FAQs

The AVENTUS Thrombectomy System is designed to treat acute pulmonary embolism by extracting obstructive clots from the pulmonary arteries using a next-generation aspiration-based mechanical thrombectomy catheter and a blood return system. It’s being studied in the AVENTUS Clinical Study.

The AVENTUS Thrombectomy System is currently approved for peripheral use in the U.S. However, it is investigational use only for pulmonary embolism. Only participants in the AVENTUS Clinical Study are eligible to receive treatment with the AVENTUS Thrombectomy System for pulmonary embolism at this time.

The treatment involves the use of a catheter with a soft tip to remove blood clots from your patient’s lungs. The blood clots are then filtered out, and blood may be returned to the patient.

Your participation in the clinical study is voluntary, and you may withdraw at any time.

Each patient enrolled in the study will be asked to sign an Informed Consent document explaining the procedure along with risks and potential benefits. You will be asked to complete various tests to confirm your eligibility for the study prior to receiving treatment with the AVENTUS Thrombectomy System.

You will be in the study for approximately 30 days after the procedure. This includes follow-up checks.

Any information that can identify you, such as your name, will remain confidential. You will be identified in the study by a code.

Taking part in this study does not mean that you will benefit from treatment with the AVENTUS Thrombectomy System. While it is possible that the treatment with the AVENTUS Thrombectomy System may help in reducing the blood loss during the procedure, may help in removal of the blood clot(s) in your lungs and may reduce the length of your hospital stay, you might not have any benefits from taking part in this study.

Although you may not receive benefits yourself, your taking part in this study may provide new information about the treatment of acute pulmonary embolism

The AVENTUS Thrombectomy System for treatment of acute pulmonary embolism is not FDA-approved or cleared. The safety and effectiveness of this device for the treatment of acute pulmonary embolism has not been established. You may have some unwanted effects and symptoms as a result of this procedure. There may be risks that are not currently known.

Inquis Medical (the study sponsor) will pay for certain items and services that you may receive if you take part in this study. You will have to pay for the items or services for which the study sponsor does not pay, such as things that are part of your regular medical care. If you have insurance, the hospital will submit claims to your insurance for items and services that the study sponsor does not cover.