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| Jarvik Heart | |
|---|---|
| Name | Jarvik Heart |
| Inventor | Robert Jarvik |
| Developer | Jarvik Heart, Inc. |
| Introduced | 1982 |
| Type | Artificial heart |
| Related | Heart transplantation, Left ventricular assist device |
Jarvik Heart The Jarvik Heart is a family of permanent and temporary total artificial heart devices developed for end-stage heart failure and cardiac replacement therapy, originating from research by biomedical engineers and institutions associated with Robert Jarvik, University of Utah, Columbia University, University of Michigan, National Institutes of Health and collaborators. The device and its clinical use intersect with developments in cardiac surgery, transplantation immunology, biomedical engineering, vascular surgery and regulatory processes involving the United States Food and Drug Administration and international health agencies. Early milestones involved collaborations with surgeons, hospitals and research centers such as National Institutes of Health Clinical Center, NewYork-Presbyterian Hospital, University of Pittsburgh Medical Center and commercial partners like Symbion and Jarvik Heart, Inc..
Development traces to experimental ventricular replacement work in the 1960s and 1970s at University of Utah and funding from agencies including the National Science Foundation and National Institutes of Health. Key figures and institutions included Robert Jarvik, Michael DeBakey, Denton Cooley, Paul Winchell (early patent connections), and surgical programs at University of Utah Hospitals, Baylor College of Medicine, Hahnemann University Hospital and Harvard Medical School affiliated centers. Clinical trials and first human implant attempts intersected with landmark cases at institutions such as Houston Methodist Hospital, NewYork-Presbyterian Hospital, University of Pittsburgh Medical Center and raised discussion among professional societies like the American College of Cardiology, American Heart Association and Society of Thoracic Surgeons. The device’s pathway involved interactions with regulators at the United States Food and Drug Administration, investigators at National Institutes of Health, legal counsel from firms tied to medical device litigation, and commercial transitions involving companies such as Symbion and later Jarvik Heart, Inc..
The Jarvik Heart family incorporates pneumatic and electromechanical designs influenced by concepts from researchers at University of Utah, University of Michigan, Columbia University, Cleveland Clinic, Mayo Clinic and engineering groups supported by National Science Foundation grants. Major components include synthetic ventricles, biocompatible blood-contacting surfaces developed with input from biomaterials groups at Massachusetts Institute of Technology, Johns Hopkins University, Duke University, and sealing and valve systems similar in engineering lineage to prostheses used at Cleveland Clinic and Mayo Clinic. Drive consoles and power systems were developed in collaborations or comparisons with contemporaneous assist devices from Thoratec Corporation, HeartMate, VADs projects at University of Pennsylvania and international programs in France, Germany, and Japan. The device architecture emphasizes redundancy and hemodynamic support comparable to native circulation described in textbooks from Oxford University Press and protocols at St. Bartholomew's Hospital and Guy's Hospital.
Clinical deployment involved selected patients with end-stage cardiac failure referred from centers like Cleveland Clinic, Mayo Clinic, UCLA Medical Center, Mount Sinai Hospital, Brigham and Women's Hospital, Johns Hopkins Hospital and Massachusetts General Hospital. Indications paralleled criteria used in heart transplantation programs at Papworth Hospital, Royal Brompton Hospital and transplant registries maintained by organizations such as United Network for Organ Sharing. Case reports, series and investigative device trials were published by clinical investigators affiliated with University of Utah, University of Pittsburgh Medical Center, Columbia University Medical Center and international centers in France and Germany, involving multidisciplinary teams including cardiologists from American College of Cardiology programs and surgeons from Society of Thoracic Surgeons networks.
Implantation procedures were refined by cardiac surgical teams at University of Utah Hospitals, University of Michigan Hospitals, Baylor College of Medicine, Houston Methodist Hospital and NewYork-Presbyterian Hospital and referenced operative techniques from textbooks and manuals used at Johns Hopkins Hospital and Cleveland Clinic. The operation involves median sternotomy, cardiopulmonary bypass protocols standardized by perfusionists trained at Mayo Clinic School of Health Sciences and vascular anastomoses attended to by surgeons from programs affiliated with Harvard Medical School and Stanford University School of Medicine. Perioperative management incorporated critical care practices from Intensive Care Society guidelines and transplant immunosuppression regimens developed in centers like Massachusetts General Hospital and University College London Hospitals.
Reported survival, quality-of-life outcomes and complication profiles were documented by investigative teams at University of Utah, University of Pittsburgh Medical Center, Cleveland Clinic, Mayo Clinic, Columbia University and summarized in conferences hosted by American Heart Association, European Society of Cardiology and Society of Thoracic Surgeons. Major complications paralleled those seen with other total artificial hearts and included thromboembolism, hemorrhage, infection, device malfunction and end-organ dysfunction; management strategies referenced practices from Centers for Disease Control and Prevention infection control guidance and anticoagulation protocols from American College of Cardiology statements. Longitudinal follow-up engaged registries and post-market surveillance coordinated with United States Food and Drug Administration and professional bodies at European Medicines Agency and international transplant registries.
Regulatory interactions involved investigational device exemptions and premarket approvals submitted to the United States Food and Drug Administration and analogous submissions to the European Medicines Agency for CE-marking discussions; commercial partners included Symbion, Jarvik Heart, Inc. and device distributors with ties to multinational medical technology companies referenced in filings to Securities and Exchange Commission. Health technology assessment and reimbursement negotiations engaged national payers and agencies such as Centers for Medicare & Medicaid Services and hospital purchasing groups at major institutions including Mayo Clinic and Cleveland Clinic.
Ethical debates emerged involving patient consent, allocation of scarce resources in transplant programs at centers like Papworth Hospital and University Hospitals of Leuven, end-of-life decision-making discussed within forums at American Medical Association and British Medical Association, and litigation over device advertising, inventor attribution and intellectual property involving law firms and courts including filings in United States District Court and appeals to the United States Court of Appeals. Public communication and media coverage involved outlets with reporting from institutions such as New York Times, academic commentaries from Harvard Medical School faculty, and policy discussions at meetings of National Institutes of Health and professional societies like the American College of Cardiology.
Category:Artificial hearts