Technology developed for jet engines doesn’t sound like it would be of much use in a medical procedure.
But for Atlanta-based CardioMEMS and its co-founder, Dr. Jay Yadav, using jet-inspired wireless microsensor technology eventually led to a big payoff. And hopefully, many heart failure patients will benefit as well.
The FDA in May approved CardioMEMS’ miniaturized, wireless monitoring sensor that directly measures pulmonary artery pressure.
The basic purpose of the device is to improve monitoring of heart failure patients, but the ripple effects may be much greater. The better data can help reduce hospitalizations, and that in turn can reduce health care costs. (Experts agree that avoidable hospitalizations are a huge driver of health care spending.)
“It’s a good example of research being translated into something people can use,’’ says Yadav, a cardiologist and CardioMEMS CEO.
The FDA approval immediately triggered the acquisition of CardioMEMS by St. Jude Medical, a Minnesota-based medical device company.
About 6 million patients in the United States have heart failure, the inability of the heart to pump sufficient blood to meet the body’s needs. The condition often leads to hospital admissions.
“I was seeing a number of my heart failure patients [have] hospitalizations,’’ says Yadav.
Tiny but effective
The CardioMEMS device, the size of a paper clip, is implanted in the pulmonary artery using a catheter procedure. Afterward, clinicians can stabilize pulmonary artery pressure by managing medications and using other treatments.
CardioMEMS was co-founded in 2001 by Yadav and Mark Allen, a professor in Georgia Tech’s School of Electrical and Computer Engineering and director of the school’s MEMS research group.
MEMS stands for microelectromechanical systems.
The device was created at Georgia Tech, based on technology created to sense the pressure changes in jet engines. Yadav says monitoring devices with wires and batteries tend to break and have to be replaced.
“It took us about five years to solve the technological problems, creating a sensor that was stable,” he says.
The fledgling company raised money through private individuals, venture capitalists and companies such as St. Jude, which in 2010 bought a 19 percent share of the privately held CardioMEMS for $60 million, and had an option to buy the remainder of the firm for $375 million (which it has done).
More than 60 hospitals took part in the clinical trials, including several in Georgia.
The clinical study showed a statistically significant reduction in heart failure-related hospitalizations for the participants whose doctors had access to pulmonary artery pressure data.
Emory Healthcare participated in the clinical trials, and Dr. Javed Butler, a cardiologist there, has been a consultant for CardioMEMS.
Butler calls it a “breakthrough’’ device.
“It’s simple, very safe,’’ Butler says. “It’s directly measuring what we’re trying to measure.”
The device is easily implanted, Butler adds.
He notes one issue with such devices that is still unresolved: Who will actually do the constant monitoring of patient data – physician, nurse, or hospital?
Jobs for Georgia
Strong sales are predicted for the device. Michael Weinstein, an analyst at J.P. Morgan, said in a Reuters article that the CardioMEMS system “has the chance to be one of the more meaningful technological advances in heart failure management in recent memory.”
The CardioMEMS device is manufactured in Atlanta, and the company employs about 90 workers.
The process to FDA approval “has been a team effort,’’ Yadav says. The hospitals worked together, and CardioMEMS had strong support from government and Georgia Tech, he adds.
Yadav will serve as an adviser to CardioMEMS and St. Jude Medical.
He adds that he plans to spend time “chilling out with my children.”
Then, he says, “I’ll come up with something else.”