ACTIVE MIXING MEMBRANE OXYGENATOR PHASE II

Ension, Inc. and its development partner, the University of Pittsburgh, have developed and patented an active mixing membrane oxygenator (AMMO), which has been proven to be highly efficient in terms of oxygenation and decarbonation (5-8 times that of oxygenators currently in use), capable of pumping blood and atraumatic to blood. The AMMO achieves its efficiency by rotating flow-through discs of microporous hollow fiber membranes, which are mounted on a double lumen shaft, through blood significantly minimizing fluid phase resistance. In vitro and in vivo data have been collected to substantiate our claims of highly efficient mass transfer and blood pumping with minimal blood damage. Our proposed Phase II plan includes refinement of current AMMO designs to provide at least 7.0 Lpm of blood flow and adequate gas transfer, oxygen transfer of 400 ml/min and carbon dioxide transfer of 250 ml/min, in a device with 0.5 sq. m. fiber surface area. These capabilities should be sufficient to support adult patients during open-heart surgery. Fabrication methods will be moved from the development laboratory to a semi-automated manufacturing process that will enable the production of high quality devices in numbers adequate to support full evaluation per MMI standards. In vivo testing in calves (12 per year) will commence with acute testing of improved devices and move to experiments that follow current FDA guidelines. Finally, it is proposed that 6 animal experiments in Yr. 02 be conducted on our final prototype and this data, in addition to that generated in the Phase III development, be submitted to the FDA to support our claim of device readiness for a human clinical trial.