December 5, 2011 / 10:01 PM / 8 years ago

UPDATE 4-FDA staff say CardioMEMS device works

* CardioMEMS device for heart failure meets study goals

* FDA staff warn of potential bias in company study

* Stakeholder St Jude shares rise about 3.9 percent

By David Morgan

WASHINGTON, Dec 5 (Reuters) - U.S. health regulators on Monday said a CardioMEMs implant for treating heart failure met its main safety and effectiveness targets but warned of potential bias in the company’s research.

A Food and Drug Administration staff review of the CardioMEMS Champion HF Monitoring System also questioned the clinical significance of trial results showing that the wireless product reduced costly hospitalizations among heart failure patients.

But industry analysts brushed aside the questions and predicted the Champion system would win backing from an outside FDA panel of experts who are scheduled to review it at a hearing on Thursday.

The expert panel’s conclusions could determine whether CardioMEMS is acquired by stakeholder, St. Jude Medical Inc. , which has an exclusive option to acquire the 81 percent of the Atlanta start-up it does not already own, analysts say. St. Jude couldn’t be reached immediately for comment.

Shares in the St. Paul, Minnesota medical device maker closed up about 3.9 percent to $37.21 on the New York Stock Exchange on Monday.

FDA approval would make Champion the first permanently implanted monitor for advanced heart-failure patients on the market, with a sales potential that analysts say could reach $1 billion in the domestic U.S. market and up to $2 billion abroad.

That could depend on how Thursday’s panel views FDA staff questions about the CardioMEMS research.

“I don’t think this is enough to torpedo it,” said Mizuho Securities USA analyst Michael Matson, who scaled back his odds on a panel recommendation to 60 percent from 75 percent.

“But the hearing will probably be a little more controversial than people first thought,” he told Reuters.


A company-funded clinical study showed a statistically significant reduction in hospitalizations among 270 heart failure patients whose treatment was guided by readings from the device’s wireless sensors implanted in their hearts via catheter.

The sensors measure pressure in the heart and transmit the findings to computers monitored by physicians and patients.

FDA staff asked the advisory committee to comment on the clinical significance of the findings, including an 8.2 percent risk reduction in the proportion of patients who were hospitalized.

But Matson said the main issue would likely be the question of research bias raised by treatment recommendations from CardioMEMS nurses. FDA staff said the recommendations, which nurses e-mailed and telephoned to scientific investigators conducting the study, went beyond the research protocols.

FDA staff said CardioMEMS’ involvement may have helped minimize the number of hospitalizations among patients in the study’s treatment group.

“FDA is concerned that the study results may be biased and that the ability to interpret study results may be compromised,” staff said in an addendum to the review.

In a response filed with the FDA, CardioMEMS said the regulatory agency has produced no evidence that its actions were inappropriate or led to biased results.

“Email alerts had no discernible impact on the outcomes in the treatment group. The investigators acted independently of the email recommendations offered for their consideration and continued to get excellent outcomes,” the company said.

The elimination of costly hospitalizations could be a powerful selling point among regulators.

The cost of treating elderly patients with chronic illnesses, including heart disease, is a major driver of spending for Medicare and Medicaid, the national healthcare programs for the elderly and the poor, respectively.

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