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- W2001239994 abstract "The Symphony is a new circulatory support device that can be implanted with a superficial operation and provides synchronous, partial circulatory support. Potential advantages are:1) less invasive operation,2) promotes heart recovery,3) improved hemodynamics to allow up-titration of meds, and 4)avoids sternotomy. We present pre-clinical implant data in support of the first-in-man clinical trial. The Symphony system has 3 components:1) 30 ml pumping chamber that is sewn via a short graft to the subclavian artery, 2) a wearable (<2.3 kg) pneumatic driver and, 3) subcutaneous (subQ) EKG leads. The device is placed through an infraclavicular incision as for pacemaker placement. Hemocompatibility is achieved with tangential inflow that creates continuous washing and no objects (valves, impellers) in blood path. The device removes blood from arterial circulation during systole to provide afterload reduction and returns blood during diastole to augment coronary and systemic flow. In a bovine model, the device was sewn to the carotid artery with superficial placement in the neck to assess the subQ leads (n=4,7 days, n=2, 14 days) and final device design (n=5, 14 days, n=6, 30 days-2 complete,4 ongoing). All animals were maintained on support with no episodes of device malfunction. At explant, all pumps and grafts had excellent hemocompatibility with absence of deposits on all blood contacting surfaces. There was no significant hemolysis. Necropsies had no evidence of thromboembolism. SubQ EKG leads were easily placed through the original incision. R wave detection with subQ leads was equal to epicardial leads at rest (beats analyzed 133,627, PPV(positive predicted value) =95.6%,sensitivity=95.1%) and with exercise (beats analyzed 37,154, PPV=92.7%, sensitivity=90.0%). We have demonstrated excellent hemocompatibilty and device function. This is the first long-term circulatory support device that can be placed with a minor operation. This operartive approach combined with synchronized suppport may increase the incidence of myocardial recovery and improve tolerance of HF meds. Device and implant costs will be less than current devices. Final preparations for a FIM clinical trial are underway." @default.
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- W2001239994 date "2011-08-01" @default.
- W2001239994 modified "2023-09-26" @default.
- W2001239994 title "Development of a Long-Term Superficial Device for Partial Circulatory Support" @default.
- W2001239994 doi "https://doi.org/10.1016/j.cardfail.2011.06.137" @default.
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