This week saw US Cardiovascular technology company CardioMEMS submit study data relating to its Champion Heart Failure Monitoring System for review by the FDA’s Circulatory Systems Device Panel Advisory Committee. A favourable FDA panel review is often seen as a precursor to FDA approval, but in this case Reuters reports that six out of 10 members of the committee of outside experts said they could not determine whether the potential benefits of the wireless pressure sensor and its supporting computer monitors outweighed potential risks. Furthermore the trial failed to prove its effectiveness on a 7-3 vote, although the panel voted 9-1 that it was proven safe.
“This device is the cat’s meow. We all want it to work.”
CardioMEMS is 19 percent owned by St. Jude Medical Inc. with an exclusive option to acquire the remainder. Analysts have said that a positive panel verdict could have set the stage for St. Jude to buy the remainder of the company for $375 million.
The Champion HF Monitoring System comprises an Implantable Sensor/Monitor with Delivery Catheter, a Patient Electronics System or Hospital Electronics System which is effectively a “wand” which when passed over the patient collects relevant data, and a Patient Database to which data is uploaded.
The system is used by the physician in the hospital or office setting to obtain and review PA Pressure Measurements. The Champion HF Monitoring System is used by the patient in the home or other remote location to wirelessly obtain, monitor, and send hemodynamic and PA pressure measurements to a secure database for review and evaluation by the patient’s physician
A study of 550 heart failure patients funded by CardioMEMS suggested that heart failure treatments guided by pulmonary artery pressure readings from the sensor led to a statistically significant reduction in costly hospitalisations among patients when compared with standard treatment for heart failure.
FDA panels are intended to establish both safety and effectiveness of the devices they are reviewing. In this case they found the CardioMEMS Champion HF Monitoring System to be safe for its intended target population of patients suffering from moderate heart failure. However the case for effectiveness was undermined by an FDA staff report that said the company intervened in clinical research to a degree that exceeded a study protocol. Disappointed panel members said they could not determine how much of the benefits stemmed from the mechanism and how much from the high level of medical attention afforded to study patients by company-employed nurses.
FDA panel comments
“Everybody believes something good happened here. But we can’t say why,” said Dr. Jeffrey Borer of the State University of New York, who chaired the committee.
Added Dr. Richard Lange of the University of Texas: “This device is the cat’s meow. We all want it to work.”
The committee’s verdict also disappointed supporters of the device including Dr. Lynne Warner-Stevenson of Brigham and Women’s Hospital who had worked on the study.
“We’re losing the battle of hospital admissions and it’s a big battle,” she said after the FDA panel’s meeting.
“This artificial distinction between the signal and the system,” she added. “We’re having trouble dealing with this distinction because it clearly all comes together.”
Formal FDA approval would give CardioMEMS the first implantable stand-alone heart failure diagnostic system in the United States, with an estimated potential US market value of $1 billion and prospects for up to $2 billion more in additional sales worldwide.
The system taps into the increasing need the world over to reduce hospitalisation from a patient well-being as well as financial perspective.
Source: Reuters, FDA, medlatest staff