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The MARS is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal and/or ion exchange resins.

The MARS is indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT).

The Prismaflex control unit is intended for:

• Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms . or more with acute renal failure and/or fluid overload.
• Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or . more with diseases where removal of plasma components is indicated.
• Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS . system to conduct MARS treatments for patients weighing 20 kilograms or more.

All treatments administered via the Prismaflex control unit must be prescribed by a physician.

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This document is a 510(k) premarket notification for a medical device (Molecular Adsorbent Recirculating System (MARS®) Prismaflex® System). It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text. The document is primarily an FDA clearance letter and an "Indications for Use Statement," which lists the intended uses and contraindications of the device. It does not include details on performance studies, validation methods, or specific study results that would fulfill your request.

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