(Updates with comments from company in 12th paragraph.)
Dec. 8 (Bloomberg) -- CardioMems Inc., the heart-device maker partly owned by St. Jude Medical Inc., failed to win a U.S. panel’s backing to sell a first-of-its-kind implant to monitor patients for signs of heart failure.
The product’s benefits don’t outweigh its risks, outside advisers to the Food and Drug Administration said today in a 6-4 vote in Gaithersburg, Maryland. The FDA isn’t required to follow the recommendations.
The device from closely held Atlanta-based CardioMems would be the first permanent implant for monitoring people with advanced heart failure, FDA staff said in a Dec. 5 report. If approved, it may open a market of about 1.3 million U.S. patients and sell for about $4,000, according to an analysis by Bloomberg Industries.
“This device is incredibly innovative and almost on the border of disruptive technology in the management of heart failure,” panel member Ralph Brindis, a cardiologist at Kaiser Permanente’s Oakland Medical Center in California, said before the vote. “I feel very comfortable that the device is safe, but I don’t think we’ve proved totally its effectiveness.”
St. Jude, based in St. Paul, Minnesota, invested $60 million in CardioMems in September 2010 in exchange for a 19 percent ownership stake and an exclusive option to acquire the company for an additional $375 million.
St. Jude declined 4.3 percent to $35.83 at the close today in New York. The shares have dropped 16 percent this year.
The device is designed to monitor blood pressure in the pulmonary artery, and wirelessly transmit that data to a CardioMems website for review by a patient’s doctor.
Studies showed the product met its primary goal of reducing hospitalizations related to heart failure, FDA staff reviewers said in a Dec. 5 report that questioned the “clinical significance” of the findings.
About 20 percent of patients who had the implant were hospitalized within six months of the procedure, compared with 29 percent of those in a control group. The efficacy data may have been skewed by bias in the way the trial was conducted, FDA staff said.
CardioMems nurses who monitored patients with the implant routinely contacted study sites, based on data from the device, to suggest “extra interventions” for some patients that may have prevented the need for hospitalization, said Gregory Campbell, director of biostatistics at the FDA’s Center for Devices and Radiological Health.
“The possible bias,” Campbell told the panel, “is of serious concern here.” The “extra care” provided only to patients who received the device “could have produced some or all of the significant effectiveness results seen in this trial.”
CardioMems would offer “real-world” doctors the type of support system it provided for physicians in the trial, said Jay Yadav, the company’s founder and chief executive officer.
“The full intention is to commercialize what’s in the study,” Yadav told the panel today. “Why would you do something different?”
The product, known as the Champion HF Monitoring System, would help doctors manage the “very challenging public health problem” of heart disease, he said.
“The risk is exceedingly small for a permanent implant,” he said. “The benefit is compelling, and it increases over time.”
Jeffrey Borer, the panel’s temporary chairman, said while the device seemed to help patients, measuring that benefit was difficult because of the trial conduct.
“It does appear that there was bias,” Borer, chief of cardiovascular medicine at SUNY Downstate Medical Center in Brooklyn, New York, said before the vote. “It does appear, nonetheless, that something good happened, but we can’t tell you exactly why.”
--With assistance from Anna Edney in Washington. Editors: Adriel Bettelheim, Andrew Pollack
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