The Danvers, Mass.-based medical device company’s stock soared last week after it released its fiscal 4th-quarter and 2013 results, reporting soaring profits on solid, double-digit sales growth. Shares continued the trend today, rising about 1.5% in mid-morning trading.
In December, an FDA advisory panel recommended that some categories of heart pumps, including the Impella, be required to submit pre-market approval applications to the agency even if they’ve already been approved via the FDA’s 510(k) clearance protocol, continuing the slide for ABMD shares begun when it revealed a federal probe into its marketing of the Impella device.
Last week, chairman, president & CEO Michael Minogue told analysts during a conference call that the company expects to complete its PMA submission to the FDA by the end of fiscal 2014. The federal watchdog agency is allowing Abiomed to submit the PMA in 3 separate modules, Minogue said, consisting of preclinical testing data; manufacturing and quality systems data; and clinical data and conclusions. It’s still unclear whether the agency will ask its Circulatory Devices advisory panel to review Abiomed’s PMA before a final decision is reached, he said.
"The PMA that Abiomed intends to submit to the agency will contain all reasonably known information which includes extensive real world experience and readily available medical device reporting or MDR safety records," Minogue said during the call. "The review clock starts when the final module is submitted and the expectation is for 180 days without a panel requirement and 320 days with it. Until this is completed, everything is business as usual for Abiomed and our Impella 510(k) clearances."
Minogue said early indications are that the PMA could be granted without Abiomed having to run another clinical trial, citing its trove of data covering real-world use of the Impella pump.
"The feedback at the December panel meeting from the physicians and also the FDA indicated there could be the potential of sufficient existing data to file for PMA without doing another trial, but again we may be asked to do additional work, which could be potentially the single-arm study, prospective study or just more additional registry work or post-market analysis," he said. "We are in discussions with the agency requiring these requirements."
"We’d like to be one of the first success stories in the industry that’s converted from a 510(k) through the 515 process to PMA," Minogue added. "We’re excited to kind of be the role model.
As for the federal subpoena that kicked off Abiomed’s woes last year, Minogue said the company is still working with the U.S. Attorney’s Office for the District of Columbia "to resolve the issue and cooperate."
"We are just going to follow their path and have confidence in our ability to work with them and to resolve it one way or the other," he said. "We do not have any other comments on that."
ABMD shares were trading at $20 even as of about 11:30 this morning, up 1.5% on the day.