Hagens Berman today announced that newly published materials for the upcoming Food and Drug Administration’s (FDA) Circulatory System Devices Panel meeting raise new issues regarding Abiomed, Inc. (NASDAQ: ABMD) (“Abiomed”) discussions with the FDA concerning the safety and effectiveness of the Impella 2.5 for high-risk PCI and Abiomed’s marketing practices. The firm also advises investors who purchased Abiomed stock between Aug. 5, 2011 and Oct. 31, 2012 (the “Class Period”) of the Jan. 15, 2013 deadline for moving to be lead plaintiff in a proposed class-action lawsuit against Abiomed regarding alleged securities law violations.
Investors with significant losses who purchased or otherwise acquired Abiomed stock during the class period are encouraged to contact Hagens Berman to discuss moving for lead plaintiff in the pending class-action lawsuit. Investors can contact Hagens Berman Partner Reed R. Kathrein, who is leading the firm’s investigation, by calling (510) 725-3000 or by emailing
Any member of the proposed class may move the court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Class members need not seek to become a lead plaintiff in order to share in any possible recovery.
On Dec. 3, 2012, the FDA released briefing documents for its 515 Program Initiative Advisory Panel meeting, scheduled for Dec. 5-6, 2012, suggesting that the agency will not down-classify the device category for the Impella 2.5 from its current Class III category when used for temporary (six hours or less) prophylactic or non-prophylactic ventricular support during high-risk interventional or surgical procedures not requiring cardiopulmonary bypass. Accordingly, Abiomed may be required to file a premarket approval application requiring it to expend funds for additional clinical trials with the prospect that approval will not be granted.
The NRP 515i Executive Summary, which can be found
, states in part:
“In conclusion, FDA believes there is a lack of valid scientific evidence to support the safety and effectiveness of non-roller type blood pumps for routine temporary (≤ 6 hour) prophylactic or non-prophylactic ventricular support indications during high risk interventional or surgical procedures. Due to this lack of safety and effectiveness data, in addition to the new technology introduced as compared to typical centrifugal pumps, special controls cannot be established to mitigate the risks associated with the use of non-roller type blood pumps for these temporary cardiac support indications.”