Procedure Illustrations

FL02W Procedure Illustrations Click to view

Professional FAQs

What are the options to remove or reverse the procedure?
The study device is a permanent implant and is not intended to be removed. In the event the arteriovenous anastomosis is felt to be the source of a complication, it may be closed. Closing the anastomosis involves placing a permanent sheath or covering across the opening of the device so that blood can no longer flow through it. The technique of closure is a decision made by the treating physician in conjunction with the patient’s consent.

What are the potential risks to patients?
The subjects participating in this study may be at greater risk as a result of their disease stage and general health status. Study device or study procedure related risks may include, but are not limited to: cardiovascular and/or peripheral vascular adverse effects and all risks associated with surgical procedures. There are also risks associated with the right heart catheterization procedure, which is performed during patient screening and follow-up visits. A detailed list of anticipated risks is included in the study device protocol. The investigator will evaluate the risks on an individual basis and discuss them with each subject. This treatment may involve some additional risks to the study subject, the natures of which are unknown at this time.

What is the mechanism of action of the procedure? Why would this make a COPD patient better?

There is a combination of three major physiologic effects that support the potential benefits associated with the use of the ROX Anastomotic Coupling Procedure in advanced COPD patients: A reduction in negative effects of venous admixture; an increase in cardiac output; and improvement in hemoglobin kinetics.


For more information about the ROX Clincal Trials, please click here.

If you wish to request information about ROX Medical and the ROX Anastomotic Coupling Procedure, please email info@roxmedical.com.