WASHINGTON A U.S. Food and Drug Administration panel on Thursday decided not to recommend CardioMEMS implantable heart device for treating heart failure because supporting clinical research appeared biased by human intervention.
Six out of 10 members of the FDA advisory 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.
The vote, which will help influence a final FDA decision on whether to approve the device for sale in the marketplace, could cloud the corporate future of the Atlanta-based CardioMEMS, which is 19 percent owned by St. Jude Medical Inc..
Analysts said a positive panel verdict could have set the stage for St. Jude to buy the remainder of the company for $375 million. The St. Paul, Minnesota-based heart device maker, with more than $5 billion in annual sales, purchased its CardioMEMS stake last year for $60 million and has an exclusive option to buy the rest.
Shares in St. Jude ended trading 4.3 percent lower at $35.83 before the panel voted.
The committee found the CardioMEMS Champion HF Monitoring System to be safe for its intended target population of patients suffering from moderate heart failure.
But 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.
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 hospitalizations among patients when compared standard treatment for heart failure.
But 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.
"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 a potential domestic market value of $1 billion and prospects for up to $2 billion more in additional sales worldwide, according to analysts.
Reductions in hospitalizations offer a key selling point for regulators because the costly medical events can have a direct bearing on the direction of a heart failure patient's future health.
They also provide a financial incentive at a time when government officials are looking for ways to reduce healthcare spending on chronic diseases such as heart failure that can be common among beneficiaries of Medicare and Medicaid, the government programs for the elderly and the poor, respectively.