The objective of this effort is to develop a novel ventricular assist device for patients suffering from congestive heart failure (CHF). The system will differ from current technology as follows: 1. A totally magnetically suspended impeller will be developed to eliminate contact bearings 2. A responsive physiologic controller will be developed to match system output to patient need without the use of sensors. This system will provide the following benefits to CHF patients: 1. Significantly improved system reliability and durability relative to other devices in clinical use or in advanced development 2. Significantly improved patient quality of life by using the unique characteristics of the magnetic bearings to provide system output based on physiologic needs 3. Anticoagulation needs will be reduced, lowering the post-operative cost to the patient and reducing the likelihood of anticoagulation-related complications. The following specific objectives will be met: 1. A completely implantable continuous flow VAD configured for human use will be ready for transition to manufacturing 2. The system will include transcutaneous energy transfer (TET) system, batteries, and sealed implantable controller housing 3. One year in vitro reliability testing on complete preproduction systems will be completed 4. At least 6 complete system animal implants with a minimum 60 day duration will be completed 5. The pre-clinical readiness Design History File and Design Review will be completed 6. A partnership with a commercial funding partner will be in place to prepare an Investigational Device Exemption (IDE) application, manufacture the system, and perform the clinical evaluation. The continuous flow ventricular assist device (CFVAD) will be intended initially as a bridge to transplant, but the reliability characteristics will ultimately facilitate development of a longer term bridge to recovery and/or permanent device. By successfully completing the activities described in Section D we can provide a superior treatment option at a lower cost for those who suffer from CHF. Developing novel means of addressing reliability and physiologic control issues will significantly improve the state of the art in circulatory devices, stimulating new development in acute circulatory support devices and in acute and chronic total artificial heart applications.
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