SynCardia Science Advisory Board Experts Awarded $7.5 Million Grant to Optimize Designs of Cardiovascular Devices
Dr. Danny Bluestein's Goal to Eliminate Need for Anticoagulation with SynCardia Total Artificial Heart, Other Devices
Science Advisory Board experts have been awarded a five-year, $7.5 million grant from the National Institutes of Health (NIH) entitled "Optimizing Cardiovascular Device Thromboresistance for Eliminating Anticoagulants".TUCSON, Ariz. – Nov. 4, 2010 – On Nov. 4, SynCardia Systems, Inc., announced that three of its
Danny Bluestein, PhD, Principal Investigator and Professor of Biomedical Engineering at Stony Brook University, in collaboration with Co-Investigators Professor Shmuel Einav of the Stony Brook College of Engineering and Applied Science, and Marvin J. Slepian, M.D., Professor of Medicine (Cardiology and Biomedical Engineering) at the University of Arizona, will use the Phase II Quantum Grant, provided by the National Institute of Biomedical Imaging and Engineering (NIBIB), a division of the NIH, to optimize the design of cardiovascular devices.
"During Phase I, we developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, based on sophisticated numerical simulations," said Dr. Bluestein. "During Phase II, we will use the DTE to tweak the geometry of the devices to optimize the design and minimize or eliminate 'hot spot' trajectories where clots can form. The ultimate goal is to eliminate the need for anticoagulation in patients supported by these devices."
Dr. Bluestein is working with several companies to test and optimize the designs of various cardiovascular devices including prosthetic heart valves, left ventricular assist devices (LVADs), biventricular assist devices (BiVADs) and the SynCardia temporary Total Artificial Heart.
"This methodology may lead to enhanced devices that demonstrate a lower likelihood of clot formation, bleeding and stroke," said Dr. Slepian. "Ultimately, we envision that our methodology has the potential for advancing testing for cardiovascular devices that may be of use to the industry and the FDA."
The design optimization process includes:
- Tweaking the geometry of the original device design and conducting numerical simulations in the new design for studying "hot spot" blood flow trajectories that may activate platelets.
- Programming the new design with these flow conditions into the DTE and measuring the resultant platelet activity to see if it has been reduced.
- Iterating the process and freezing the new design once satisfactory results (device optimization) have been achieved.
- Fabricating the prototype.
- Testing the optimized design in animal and human studies.
Collaborators on Dr. Bluestein's project include Dr. Slepian and the Sarver Heart Center at the University of Arizona, Stony Brook University collaborators and four industrial partners: SynCardia Systems, Inc., MicroMed Cardiovascular, Innovia LLC and Medtronic-ATS Medical Inc. Each group will receive a sub-award of the grant for their contributions to the project.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, email@example.com, (520) 547-7463