A recent decision by an FDA advisory panel will impact existing approvals for certain cardiovascular assistance devices. With the recent decision by the advisory panel, some cardio-assistance devices will maintain Class III status. This will force Abiomed and other medical device manufacturers to re-apply for approval with the FDA. For example, Abiomed’s Impella heart pump will require a new premarket approval application.

According to the notice, the Circulatory Devices Advisory Panel stated that non-roller-type cardiopulmonary bypass blood pumps play an essential role in life support. However, the panel did not recommended shifting this class of devices to the lower-risk temporary ventricular support category.

The panel’s decision sent shockwaves through the market. Shares of Abiomed dropped as low as $12 on Friday before a slight rebound to $12.88 at market close. Abiomed, a cardiac device manufacturer based in Danvers, Massachusetts, stated that it is in a good position to undergo PMA review of its Impella cardiovascular pumps. According to the company, the Impella product line will not be pulled off the market during the re-approval process.

According to the FDA, non-roller-type cardiopulmonary bypass pumps are designated as devices that do not use revolving rollers as part of a pump mechanism to circulate blood through a cardiopulmonary bypass circuit during a heart bypass procedure. While Class III, a category that includes higher-risk devices, non-roller-type cardiopulmonary bypass pumps enjoy less-stringent PMA notification 510(k) review procedures due to a pre-1976 medtech amendment.

References

www.fda.gov/AdvisoryCommittees/Calendar/ucm327178.htm