July 3, 2007
By Michelle Miron

It’s about the size and weight of an iPod, it’s implanted in the chest like a pacemaker, and Kalamazoo-based cardiologist Dr. Tim Fischell says it has the potential to prevent 70 percent of the heart attacks that now occur worldwide each year.

Fischell said Thursday that the Guardian is the most exciting of more than 200 medical products he’s invented or co-invented with his brother and father over the past several years. With a projected worldwide market value of some $10 billion yearly, he said, the patented product also has the most commercial potential.

The basis for his enthusiasm? If, as he expects, the Guardian moves its way through clinical trials to Food and Drug Administration approval within the next three years, it will be the first personal device on the market sensitive enough to monitor the risk of an individual’s heart attack 24-7 -- and immediately warn the individual of that risk.

``Every minute it looks at your heart and asks if you’re having a heart attack,’’ said Fischell, who is director of cardiovascular research at Borgess Medical Center.

Called a ``permanently implantable ischemia detection system’’ in the medical world, the Guardian has already been approved in Brazil, where Fischell said the government has ordered 2,000 units. In 18 months, he said, it could be approved in Europe.

``This is the most exciting thing I’ve ever done in my life,’’ he said. ``It has the most powerful potential to alter the course and disrupt the diagnosis and treatment of coronary disease than anything I’ve ever been involved in.’’

The titanium-encased device is designed to be implanted under the skin just above the heart, much like a pacemaker. Using computer chips, a wire to the heart and a special antenna, it’s able to take readings of heart activity every 30 to 60 seconds. It compares readings, and if it detects that the heart isn’t receiving enough oxygen, it beeps and vibrates in one of two rhythms. One alerts the patient to consult with his doctor and another alerts him to call 911. Corresponding software allows doctors to read Guardian-generated data as soon as the patient is within eight feet of hospital computers.

If the product is approved, Fischell said, the most obvious beneficiaries will be those at the highest risk of heart attacks because of their ages and medical histories. Eventually, he said, its reach might extend to lower-risk candidates, such as men in their 50s who have experienced no heart symptoms but want to improve their odds of maintaining a healthy heart.

``Seventy-five million baby boomers are entering the coronary-disease-, heart-attack-prone age,’’ he said. ``It’s a big, big problem.’’

One of the most important functions of the Guardian will be to convince people who are in denial to take heart attack symptoms seriously, Fischell said. National statistics show that the average heart attack victim does not reach a hospital until three hours after chest pain begins, and that’s largely because patients -- especially men -- don’t acknowledge their symptoms. In 15 percent to 20 percent of all heart attacks, patients have no physical symptoms.

The biggest problem, Fischell said, is that 40 percent of heart attack victims die of ventricular fibrillation (abnormal heart rhythm) within three hours of its onset, before ever reaching the hospital and receiving treatment. Fischell says the Guardian could reduce that percentage to as low as 2 percent.

``This takes the human element of denial out of the equation,’’ he said.

In the best-case scenario, a patient would be warned of preliminary symptoms by the Guardian and the heart attack would never occur, he said. In the worst case, a heart attack would start but a call to 911 would get the patient to the hospital and intervention would take place within one to two hours of the onset, ``virtually eliminating heart damage.’’

Borgess Medical Center announced Thursday that first-phase U.S. clinical trials of the product started on Wednesday with the implantation of the Guardian in a local patient. About 25 subjects at five medical centers across the U.S., including five based at Borgess, are expected to participate in the study through this year. Phase-two studies are expected to start in 2008 with 2,000 more U.S. participants, half of whom will be implanted with the Guardian.

Fischell said the potential impact of the device hit home earlier this week, when a 50-year-old medical-school classmate of his dropped dead of an apparently unforeseen heart attack, leaving behind a wife and four young children.

``It would be wonderful if this could have saved my classmate’s life,’’ he said.

Once the device is approved and manufactured, Fischell expects insurance companies and Medicare to cover the $20,000 in estimated costs for each Guardian, its implantation (a 20-minute procedure performed under local anesthesia) and related medical services. Replacement fees every four to five years are expected to be around $10,000. Phase-2 studies will include complete financial analyses of the cost-effectiveness of the product, he said.

In comparison, he said, treatment and a typical hospital stay following cardiac arrest cost about $40,000, while medications following damage to the heart can amount to as much as $10,000 annually. Treatment for congestive heart failure is the No. 1 expense reimbursed by Medicare, he said.

Fischell, 51, said the product has been developed over the past five years through the Shrewsbury, N.J., life-sciences firm Angel Medical Systems Inc., which he co-owns with his father, Robert Fischell, and brother David Fischell. The firm employs 20 people, including computer engineers who fine-tuned the complex technology involved.

Some $25 million has already been invested by Angel Medical, by the Fischells and by venture capitalists as well as a pacemaker manufacturer and a pharmaceutical manufacturer that he declined to name. He expects another $100 million to be needed to bring the product to market, but sees no problem securing those funds.

Because the Guardian is ``too big to shuffle off,’’ Angel and/or its owners will eventually make plans to handle its manufacture, marketing and sales, he said. He said it’s not out of the question that such functions would take place in Kalamazoo, bringing jobs and commerce.

Future generations of the product could include a one-third reduction of its size and cellular technology that would allow a centralized agency to call a patient when his Guardian alarm is set off.

``It’s not perfect,’’ he said of the product. ``People will still die. But this is way better than anything we’ve ever had before, in that it gives us the ability to disrupt or prevent the onset of large-scale cardiac arrest.

``In the scope of things I’ve done in my life, this has the biggest potential to impact medicine and save lives,’’ he said.