Using data collected by non-invasive medical technology, the HeartFlow system can tell cardiologists which patients require an invasive cardiac-diagnostic procedure and which patients do not. In so doing, HeartFlow developers say, it has the potential to save money, lives and improve patient outcomes.
"If it delivers what we believe it will, it's going to have a real significant impact," said Dr. Fred St. Goar, an interventional cardiologist at El Camino and clinical advisor for HeartFlow.
According to St. Goar, more than 50 percent of patients who undergo the invasive procedure, known as an angiogram, do so unnecessarily.
In an angiogram, a catheter is inserted into the patient — often through an artery in the groin or arm — and threaded all the way up to the heart. Then, X-ray-visible dye is injected into the blood to give doctors a view of blockages in the heart and nearby arteries. HeartFlow aims to eliminate all unnecessary angiograms.
It works by taking data collected by non-invasive heart-monitoring technologies, already in use at hospitals and doctors' offices across the country, and funneling that data through fluid dynamics equations — similar to those applied by aerospace engineers to cut down on aircraft drag.
The HeartFlow software uses these equations to calculate the rate at which blood is flowing before and after a blockage. If the software shows that blood flow is being significantly impeded by a blockage, cardiologists may then proceed with more drastic procedures. If, however, blood flow is not significantly hindered, doctors will be able to say with confidence that no invasive procedure is necessary. And the fewer invasive procedures, the better, representatives from HeartFlow said.
"Patients are going to have better outcomes with less risk," said Dr. John Stevens, a cardiovascular surgeon and CEO of HeartFlow. "At the same time, we are going to save the health care industry billions and billions of dollars."
Costs for angiograms vary from hospital to hospital. According to a representative at O'Connor Hospital in San Jose, the average cost for an angiogram there is $10,587. St. Goar estimated that an angiogram could cost as much as $15,000. An Associated Press article, which ran in USA Today on May 3, said that more than a million Americans get an angiogram each year.
The system, created by two Stanford cardiologists — Dr. Christopher K. Zarins and Dr. Charles A. Taylor — had no trouble attracting support from Dr. Thomas J. Fogarty, founder of the Fogarty Institute for Innovation.
"It's one of the more exciting technologies that I've ever been involved in," Fogarty said.
Fogarty's medical startup incubator was instrumental in bringing the HeartFlow system to fruition.
"The Fogarty Institute was the gestational ground, the nurturing ground" that allowed HeartFlow get up and running, Stevens said.
Fogarty opened his non-profit institute on the El Camino Hospital campus in September 2007 with the intent to nurture innovators in the field of medicine. The 4,000-square-foot collection of offices and a laboratory are home to Fogarty's handpicked startups, which receive funding and logistical support.
The medical entrepreneurs working out of the institute have access to free legal and business advice. And because it is located on the El Camino campus and has Fogarty's name attached to it, the institute attracts doctors willing to try out new products on their patients.
"They were really critical in the first 18 to 20 months," Stevens said. The institute provided HeartFlow "all of the things a young company has a hard time getting" — including the "sage advice and experience" of Fogarty.
Fogarty is a world-renowned cardiologist and innovator, who has been in the medical field for more than 40 years. Among his many inventions is the balloon embolectomy catheter, which is the industry standard tool for removing blood clots in and around the heart.
"Fogarty is just one of those rare breeds," said Ann Fyfe, executive vice president of Fogarty Institute. She said that as a surgeon, businessman and entrepreneur familiar with bringing new products to market, Fogarty is uniquely positioned to help fellow inventors reach their goals.
St. Goar agreed, saying that it is difficult to get new medical treatments patented, approved by the FDA and successfully to market.
"Many hundreds of great ideas have died on the vine," St. Goar said.
It would seem that HeartFlow has escaped that fate. El Camino is just one of 18 trial sites nationwide conducting clinical validation trials of the system.
The system's success is not only providing validation for its creators, but for the Fogarty Institute as well. HeartFlow is the first company to move successfully from concept, through development and into clinical trial.
"It feels wonderful," Fogarty said of HeartFlow's success and his institute's role in it. "As a surgeon and a cardiologist, you help one patient at a time. Even more rewarding is when you are involved in something that benefits a whole bunch of patients."