What if physicians and surgeons could virtually analyze their patients’ health and plan therapies and surgeries using the same advanced simulation technology that the automotive, aerospace, energy and hi-tech industries rely on to test their product before they are built? What if medical devices could be designed and safely tested in the virtual world before ever being tested in the real world?
The Living Heart Project is uniting leading cardiovascular researchers, educators, medical device developers, regulatory agencies, and practicing cardiologists on a shared mission to develop and validate highly accurate personalized digital human heart models. These models will establish a unified foundation for cardiovascular in silico medicine and serve as a common technology base for education and training, medical device design, testing, clinical diagnosis and regulatory science —creating an effective path for rapidly translating current and future cutting edge innovations directly into improved patient care.
The Living Heart Project is driven by a growing ecosystem that is fueling the collaborative development of validated, commercially available heart models and exploring novel digital therapies. The Living Heart Project signed a five-year collaborative research agreement with the United States Food and Drug Administration (FDA). Together with the Project participants listed below, testing paradigms beginning with the insertion, placement and performance of pacemaker leads and other cardiovascular devices are being evaluated, bringing the Living Heart Project closer to providing personalized, interventional cardiac-patient care.
The collaboration with the U.S. Food and Drug Administration was recently extended for an additional five-years to spur medical device innovation by enabling innovative, new product designs. This second phase of this ongoing collaboration supports the 21st Century Cures Act, using virtual patients based on computational modeling and simulation to improve efficiency of clinical trials for new device designs. A groundbreaking project with the Living Heart simulated 3D heart model will examine the use of heart simulation as a source of digital evidence for new cardiovascular device approvals. This includes an in silico clinical trial aimed to reduce animal testing or the number of patients required while still ensuring safety and efficacy of the device is demonstrated. The new digital process is intended to be more efficient and less expensive than current ones – whose delays and costs can impede patient access to novel treatments – without losing rigor or confidence in a device’s safety and efficacy. Researchers hope the first-of-its-kind process will increase industry innovation and pave the way for an efficient path for patients to access safe, effective new treatments for the world’s leading cause of death – heart disease.