For Heart Patients a Guardian Angel

Ocean Twp. man first in area to try device used abroad that awaits FDA approval

Charles Theodora did not find out he had his first heart attack until he suffered a second one last month.

"I've always been pretty healthy and in good shape. But then I felt like I had heartburn, and I got this feeling in my throat," Theodora, 66, of Ocean Township, said Monday. "The next day I felt some pain that went from my neck down my chest. That's when I thought I might be having a heart attack."

After arriving at Jersey Shore University Medical Center for cardiac catheterization, which Theodora said failed, he was told he needed open heart surgery. He underwent a quadruple bypass Feb. 28.

Nearly a month later, on Thursday, Theodora was back at Jersey Shore to have an experimental medical device -- the AngelMed Guardian cardiac monitor and alert system -- implanted in his chest.

He is the first patient in the New York-New Jersey metropolitan area to be implanted with the device as part of a clinical research trial that Angel Medical Systems of Shrewsbury must complete in order for the federal Food and Drug Administration to approve it.

Jonathan Harwood -- chief operating officer of AngelMed, as the company is known -- said the device is already available in Brazil, and the company recently received approval to sell it in Europe. The next step is to make it available in the U.S.

Clinical trials are being conducted at 75 heart and medical centers throughout the U.S. on a total of 900 patients to prove the efficacy of the device and secure FDA approval, Harwood said. So far, the device has been implanted in about 175 patients, mostly in the Midwest, West and Southeast, he said.

Theodora -- the only New Jersey patient to participate so far -- said the device will get him to pay attention to any future symptoms.

"It's nice to know you have an angel watching over you," he said, and added that the device is roughly the size of an Oreo cookie.

"As a diabetic, I have a high tolerance for pain, and I guess I didn't feel or know the symptoms of a heart attack the first time," said Theodora, who retired three years ago and likes to fish on his 42-foot boat.

He and his wife, Ruth, have two adult children, Charles Theodora Jr. and Amy Kipnis, and four grandchildren who all live in Ocean Township.

Dr. Charles Koo, a cardiologist with the Meridian CardioVascular Network and principal investigator for the Jersey Shore clinical trial, said the key to the device is its ability to track significant changes in the heart's electrical signal and then alert the patient to seek medical attention immediately.

"If this system proves to be effective in early detection and warning of potentially life-threatening heart conditions, we may be able to shift the paradigm for early treatment at the onset of heart attacks," Koo said.

Helping Patients

AngelMed was founded by Robert E. Fischell, now 82, of Maryland -- one of the inventors of the pacemaker and internal defibrillator -- and his son David R. Fischell of Fair Haven, a former research engineer at Bell Labs.

A study completed in 2006-07 in Sao Paolo, Brazil, determined that the device was safe to implant in patients, Harwood said.

It also found that 37 patients who had the device implanted and had a cardiac event got to the hospital in 20 minutes, rather than three hours, which was the average amount of time it took for patients who experienced symptoms to actually decide they might be having a heart attack and then seek medical treatment.

The device is manufactured in Hackettstown, with some of the ancillary pieces made in Shrewsbury. About 55 research engineers, many of them former Bell Labs employees, work for the company.

Harwood said experimental and clinical studies have shown that most of the damage to the heart occurs two hours after coronary occlusion.

"We've designed the device to warn patients of this and other cardiac events hours -- perhaps even days -- before they occur," he said.

According to the American Heart Association, one in every five deaths in the U.S. is attributable to coronary disease, and 50 percent of heart attack fatalities occur within one hour of the onset of symptoms and before a patient even reaches the hospital.

To participate in the clinical trial, patients must have had a heart attack or open heart surgery within the past six months and meet other specific criteria, like having diabetes.

For more information, visit www.jerseyshoreuniversitymedicalcenter.com or call the center's research services department at 732-776-2953.