CORRECT: IN THE PIPELINE: Sensor Could Help Keep Heart-Failure Patients Home

Heart-failure patients have a hard time avoiding hospitals, but a new implantable sensor could help by giving doctors data to catch worsening symptoms and guide treatment while patients are still home.

A private company called CardioMEMS Inc. makes the wireless device, which detects increasing artery pressure that can presage fluid retention that often leads to hospitalization. By relaying this data to doctors daily over a secure website, the hope is patients can adjust their medication to improve treatment and ward off trips to the hospital.

The device is under review with the U.S. Food and Drug Administration and could be approved late this year. St. Jude Medical Inc. (STJ) stands to benefit because it bought 19% of CardioMEMS through a $60 million equity investment last year and has an exclusive right to buy the rest for $375 million.

Heart failure, which can be brought on by problems like high blood pressure or damage from heart attacks, afflicts nearly 6 million Americans and leads to more than 1 million U.S. hospitalizations each year. A 2009 study published in the New England Journal of Medicine showed more than a quarter of Medicare recipients with heart failure end up re-hospitalized within 30 days following an earlier stay. These visits rack up billions of dollars in costs.

"The burden is really enormous," said William Abraham, director of cardiovascular medicine at the Ohio State University Medical Center. He helped lead the key trial for CardioMEMS' sensors and has received consulting fees from that company, St. Jude and Medtronic Inc. (MDT).

Failing hearts don't pump well enough, and patients are often managed with drugs and implantable defibrillators, depending on their condition. Doctors say it's easy to monitor patients for problems when they're hospitalized, but that monitoring methods used outside are either imprecise or don't provide early enough warnings.

"In outpatients, you don't have quite a handle on what's going on," said Larry Epstein, chief of electrophysiology at Brigham & Women's Hospital in Boston.

The battery-free CardioMEMS sensor, which is implanted by catheter in the pulmonary artery exiting the heart, takes its daily reading when patients lay on a big pillow containing an antenna. St. Jude--which expects to complete the CardioMEMS purchase--declined to estimate the cost for this system, although CardioMEMS founder and Chief Executive Jay Yadav suggested it could fetch between $10,000 and $14,000.

In the CardioMEMS-funded trial of 550 previously hospitalized heart-failure patients, those monitored daily with the sensor had a 39% reduction in hospitalizations related to heart failure at 15 months compared with patients who also had a device implanted, but weren't managed based on daily pressure readings. There was a low rate of complications.

Abraham, who estimated it costs $10,000 to $15,000 to hospitalize heart-failure patients, noted that four patients in the study had to be treated with sensors to avoid one hospitalization at 15 months. Twice as many patients had to be treated with sensors to avoid hospitalization at six months, suggesting a potential trend toward cost-savings over time, he said.

Doctors believe the technology could be broadly used, although there could be challenges replicating conditions from the study in the real world. Liviu Klein, a heart-failure specialist at Northwestern Memorial Hospital in Chicago who took part in the study, said it takes at least an hour to implant the device, raising manpower challenges if every eligible patient wants a sensor. Klein also believes that, while the sensor itself is very simple, there are some drawbacks such as the bulky pillow.

Still, the successful study and sensor's simplicity set this device apart from other monitoring attempts, according to doctors. In a closely watched effort Yadav said generated important lessons, Medtronic Inc. built a system called Chronicle, implanted like a pacemaker, which failed its key study and never hit the market.

Medtronic is now working on a wireless, battery-powered device that will take multiple daily readings from the pulmonary artery while relaying information to a smart phone and other devices. But it hasn't entered human trials yet and is likely several years behind the CardioMEMS device. Boston Scientific Corp. (BSX) launched a trial last year to study using sensors with defibrillators to detect worsening heart failure, but isn't divulging many details yet.

St. Jude, meantime, is also testing a more invasive sensor than the CardioMEMS device that will measure pressure from a different area.

(Jon Kamp covers medical devices for Dow Jones Newswires. He can be reached at 617-654-6728 or by email at jon.kamp@dowjones.com)

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