U.S. Panel Rejects Medtronic Implanted Heart Monitor
A U.S. advisory panel rejected a Medtronic implanted heart monitor on Thursday after concluding the company failed to show its use would lead to fewer hospitalizations from heart failure.
In a 9-2 vote, the advisers urged the Food and Drug Administration to turn down Medtronic's bid to sell the Chronicle Implantable Hemodynamic Monitoring System.
The pacemaker-sized device is implanted in the chest to collect data on heart activity and send it to doctors via the Internet. The hope is that catching early signs of worsening will prompt adjustments in treatment that can keep patients out of the hospital.
The device is among the first implants that aim to gather information but provide no treatment.
Members of the FDA panel of outside experts said the concept had potential and they hoped it would someday prove valuable for managing heart failure.
"The benefit to a clinician is so tantalizing. I so want this to work," said Dr. John Teerlink, a panel member and heart failure specialist at the San Francisco Veterans Affairs Medical Center.
But he added: "I don't believe this presents a reasonable assurance of safety and effectiveness at this time."
The FDA will consider the advice as it decides whether to allow sales of the device for patients with moderate to severe heart failure. The FDA usually follows panel recommendations.
More than 5 million Americans have heart failure, a chronic condition in which the heart has trouble pumping blood. The condition leads to nearly 1 million hospitalizations per year, Medtronic said.
The Chronicle IHM is implanted in the upper chest with a sensor attached to the heart's right ventricle. The device measures pressure inside the heart, body temperature, physical activity and heart rate.
Patients place an external monitor with an antenna over the chest to collect data for transmitting to a Web site where doctors can retrieve it. If the readings show signs of pressure and fluid build-up, doctors can adjust medications or recommend dietary changes.
Medtronic's main study of 274 patients missed the primary goal of reducing heart failure-related hospitalizations and emergency room and urgent care visits over six months.
The company acknowledged that result but said other analyses and earlier studies supported the device.
"We continue to believe in the benefit of this sound technology and intend to work in close collaboration with the FDA to define the appropriate path for approval," Dr. David Steinhaus, Medtronic vice president and medical director for cardiac rhythm disease management, said in a statement.
Medtronic is developing a device that pairs the monitoring technology with an implanted defibrillator to shock the heart back into normal rhythm, company spokesman Rob Clark said.
Other companies also are developing implanted devices that provide data, but no treatment, for various conditions.
They include St. Jude Medical