FDA panel decision means Abiomed will need new PMA for Impella pump

December 7, 2012 by Ingrid Mezo

An FDA advisory panel's decision to maintain Class III status on certain cardiovascular assistance devices means Abiomed and other device makers must re-apply for FDA approval.

Abiomed's Impella heart pump

An FDA panel decision will require some cardiovascular pump makers to submit their already-approved medical devices for review under the FDA's more stringent premarket review pathway.

The federal watchdog agency's Circulatory Devices Advisory panel this week acknowledged that non-roller-type cardiopulmonary bypass blood pumps are life-supporting, but recommended against shifting them to a lower-risk category for temporary ventricular support. Panelists also suggested down-classification into Class II (special controls) for cardiopulmonary and circulatory bypass therapy.

The decision sent ABMD shares spiraling downward today, dropping as low as $12 per share in morning trading before recovering completely to reach last night's close of $12.88 by about 3:30 p.m.

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The Danvers, Mass.-based cardiac devices maker said that it believes it's well-positioned to undergo PMA review for its star line of Impella cardiovascular pumps and that the devices won't have to come off of shelves while the company navigates the regulatory approval process.

The FDA defines non-roller-type cardiopulmonary bypass pumps (NRPs) as devices that use a method other than revolving rollers to pump the blood through the cardiopulmonary bypass circuit during bypass surgery. Although these devices are classified in the FDA's Class III category, designating devices that pose the greatest risk to patients, they fall under a pre-1976 medtech amendment that has allowed the devices to pass through the less-stringent premarket notification 510(k) review process rather than the PMA pathway.