Updated October 10, 2013, at 5 p.m. with comments from the CDRH panel.
Once-rejected CardioMEMs will get another shot at FDA approval for its Champion implantable heart failure monitoring systems when the agency’s Circulatory System Devices Panel convenes next month, according to a notice in the Federal Register.
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UPDATED Dec. 9, 2011, with comments from CardioMEMS CEO Dr. Jay Yadav, trial results
An FDA advisory panel decided that CardioMEMS failed to prove that its wireless, implantable heart monitor’s benefits outweigh its risks, casting a shadow on a potential $375 million acquisition by St. Jude Medical (NYSE:STJ) – which already owns nearly a fifth of CardioMEMS.
An FDA review found CardioMEMS’ Champion heart failure pressure measurement system safe and effective, but questioned the logic of clinical trials supporting the device’s bid for pre-market approval.
While the company’s research met its goals, the watchdog agency raised questions about heart failure therapies that were administered by nurses during the clinical trials, potentially complicating the study as look at the value of the device alone.
GI Dynamics (ASX:GID) has a new global commercial head in Mark Twyman, who was appointed this week alongside Robert Solomon, who will be VP of finance.
Twyman will oversee international expansion of sales and marketing efforts for the Lexington, Mass.-based obesity and Type II diabetes treatment company’s flagship EndoBarrier device.
Medtronic Inc. (NYSE:MDT) and CardioMEMS have dates with the FDA.
The two med-tech companies will meet with the federal watchdog agency’s circulatory systems devices panel on Dec. 7 and 8 to discuss the future of their products.
St. Jude Medical Inc. (NYSE:STJ) agreed to spend $60 million on an equity stake in CardioMEMS Inc., an Atlanta-based medical device company that’s developing a wireless system to test heart function.
The deal gives St. Jude a 19 percent stake in CardioMEMS, plus an exclusive option to acquire the company for another $375 million "during the period that extends through the completion of certain commercialization milestones," according to a press release.