Mayo Cardiologists, Device Pros Work On Cooling Implant To Treat AFib
A pair of former Boston Scientific execs have teamed up with two renowned Mayo Clinic cardiologists on what they hope could be a revolutionary new kind of implantable device that uses cooling technology to painlessly halt irregular heartbeats, or atrial fibrillations.
The promise of the Rochester-based startup, Medicool Technologies Inc., to change the paradigm in treating atrial fibrillation has earned it $250,000 in initial seed funding from the National Science Foundation via the federal Small Business Innovation Research (SBIR) grant program, which seeks to encourage small businesses to perform research having the potential for commercialization.
So far, the early-stage venture only has two actual employees, both part-time. They include president and CEO Rich Sanders, a former vice president for both Boston Scientific and Guidant Corp., now based in San Juan Capistrano, California, and Dr. Arjun Sharma of St. Paul, a medical device consultant and until last year vice president of patient safety for Boston Scientific.
Together, they form the core of the business team for Medicool, which has been founded to commercialize medical know-how developed by Drs. Paul Friedman and Samuel Asirvatham of the Mayo Clinic. Friedman is vice chair of cardiovascular medicine and director of Mayo’s implantable device lab, while Asirvatham is recognized as one of the country’s top practitioners of catheter ablation therapy to treat complex heart arrhythmias. Both have long track records of generating patents and patent applications for Mayo.
The crux of the Medicool effort is to perfect and then gain approvals for the first-ever implantable device designed to stop atrial fibrillation (AF), or irregular beating in the heart’s upper chambers caused by misfiring electrical signals.
While usually not fatal in itself, AF can increase the risk of stroke and requires medical attention. Some 2.7 million Americans are living with AF, according to the American Heart Association. Possible causes of the heart flutters include high blood pressure, previous heart attacks, coronary artery disease or congenital heart defects.
The most common means of ending the harmful irregular rhythms is delivering a shock via an external defibrillator. Implantable shock defibrillators have been tried before, but users found the pain unbearable, and because of that, an implantable option for AF has for years been deemed impractical.
Another way to treat AF is through a minimally invasive but costly surgical procedure known as catheter ablation, in which wires are inserted through a vein and threaded up to the heart. Microwaves sent out through an electrode destroys the heart tissue that is causing the problem.
But under the technology developed by the Mayo cardiologists, a much cheaper and “painless” implantable option that would also preserve heart tissue could one day be on the table.
Sharma, serving as Medicool’s chief scientific officer, said that instead of delivering electric shocks, the invention involves the application of a heat transferal methodology known as the Peltier effect, now found in some consumer products, to cool down the affected cardiac tissue and thereby cause the fibrillations to slow down or cease.
“The idea here is that within minutes, if not seconds, one could bring the heart back to normal using this implantable cooling device,” he said. “There is also scientific data showing that if you treat AF early, you can reduce the progression of the problem. So there’s a medical benefit, a societal benefit in reduced costs and a patient benefit in not having to experience the fibrillations.”
Late last year the Medicool team, led by Drs. Friedman and Asirvatham, published a “proof-of-concept” animal study in Heart Rhythm Journal in which they revealed the device employs the Peltier effect to accomplish the cardiac tissue cooling. The thermodynamic effect, in which heat transferred from a warmer surface to a cooler one when triggered by an electric current, is commonly used in consumer products such as portable coolers.
In the study, they stated early results in animal models confirmed that using cooling “enabled the termination of ventricular fibrillation and AF, suggesting that cardiac cooling may be a method to terminate arrhythmias” without pain.
Sharma says Friedman and Asirvatham have an “investment share” in Medicool and that the startup has formed a “partnership” with Mayo on developing the technology, although what form the medical and business relationship might take is still evolving at this early stage.
He added that the NSF/SBIR seed funding is the first of two phases available under the program, and will be used to perfect the engineering modeling of the device – for instance, how much of a power source would be required. A future second phase, he added, would be used to carry out initial human studies.
Sharma said that since AF is more common among the elderly, the longevity of the baby boomer generation would greatly enhance the future market possibilities for an implantable AF device.
“Not only that, but we can envision applying this cooling methodology to not just the heart, but also to other organ systems in the body,” he said.