ArterX Safety and Efficacy Study for Cardiac Indications

This is an interventional treatment trial for Vascular Disease focused on measuring ArterX, surgical sealant Read More

Inclusion Criteria:

>18 years of age, Male or female If female, subject is post-menopausal, has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure and is practicing abstinence or a highly effective method of contraception for the duration of the study.

The subject or guardian must provide written Informed Consent using a form that is reviewed and approved by the Ethics Committee.

The subject is willing and able to be contacted for 3 months follow-up and attend follow-up visits as needed per protocol.

The subject is determined by the surgeon to be at risk for poor hemostasis.

Exclusion Criteria:

Subject undergoing emergency surgery. Subject undergoing minimally invasive surgery. Subject has clinically significant medical, psychiatric, or cognitive illness or drug/alcohol abuse that in the opinion of the investigator would affect the subject's safety or compliance with study assessments or follow-up.

Subject has immune system disorders/immunodeficiency or immunosuppression. Subject has participated in another clinical study within 30 days prior to surgery or has received an investigational drug or device within the past 30 days.

Subject is pregnant, may become pregnant or is currently breast feeding

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