KAREN CHRISTMAN
University of California, San Diego
ASHLEY PETERSON
Medtronic
The heart is one of the most fundamental and critical organs of the human body. From athletic endeavors to artistic pursuits to intellectual discussions, the heart plays a vital role.
But an increasing number of ailments affect the heart and its ability to perform primary functions. Fortunately, scientific and medical knowledge of the heart and cardiovascular system are also growing rapidly. It is here, at the crossroads of medical knowledge and patient disease, that engineers must find new ways of transforming current medical understanding into solutions that can help to ensure the quality of human life.
Not so long ago the technologies available to “fix” heart ailments focused on a brute force approach. Large rigid external vascular assist devices were used to “aid” heart function. However, now there are many examples of miniature devices that provide a range of therapeutic options for the patient’s exact heart condition. As these technologies evolve, the trend is for solutions that mimic the natural biologic conditions, constructs, and behavior as closely as possible and work together with the body rather than dominate it. As such, engineered solutions to heal, repair, assist, and/or replace the heart or its critical components in a harmonious way represent the frontiers of technologies for the heart.
This session began with a description of the basic functions of the heart to give the audience an appreciation of the complexity of the cardiovascular system, and how crucial normal heart function is to the system’s stability. From there the speakers provided examples of engineered solutions to different heart problems. Specifically, a chronological overview of heart valves from their beginnings to the current best-in-class technology was provided by Erin Spinner (Edwards Lifesciences). Following on from this industrial forefront, cutting-edge research
under way on tissue engineered valves was presented by David Merryman (Vanderbilt University). Jason Burdick (University of Pennsylvania) discussed the state-of-the-art in biomaterials for treating heart tissue that has been affected by myocardial infarction. Finally, Sonna Patel-Raman (formally FDA and now Halloran Consulting Group) concluded the session with an overview of the regulatory environment and what is required to get the newest technologies to the patients who need them. This last topic is covered in a paper in this volume by Tina Morrison (FDA).