Abiomed, Inc. ABMD last night announced
that the U.S. FDA Circulatory System Devices
Panel voted to retain Class III status for the temporary ventricular support
devices within the non-roller type cardiopulmonary bypass blood pumps
category, which includes Impella®. The 515i Reclassification Panel's
confirmation of this category of device as Class III devices is consistent
with both the current Class III classification for these device types and as
recommended in the FDA's briefing documents, released on December 3, 2012.
"We would like to thank the 515i Panel and FDA for their time and
consideration, as well as Dr. Jeffrey Popma of Beth Israel Deaconess Medical
Center and Dr. William O'Neill of Henry Ford Hospital, who highlighted the
compelling body of clinical evidence supporting Impella, including the PROTECT
II data set," said Michael R. Minogue, President, Chairman and Chief Executive
Officer, Abiomed. "We look forward to collaborating with the FDA on next steps
and agree with the 515i Panel's feedback that our existing data, combined with
our U.S. registry, position us to work with the FDA to submit a PMA
application. We welcome the opportunity for a PMA to strengthen our existing
marketing clearances and expand the indications for Impella patients."
The FDA's 515i program is designed to review all previously 510(k) cleared
Class III devices and determine the appropriate controls to ensure safety and
effectiveness for the intended use of these product categories. The
classification of Impella as a Class III device requires Pre-Market Approval
(PMA) controls (versus prior 510(k) Class III special controls) to ensure
safety and effectiveness in the intended use. As per the 515i Reclassification
Process and confirmed by the FDA Panel, products will remain on the market for
a sufficient period to allow for manufacturers to submit and the FDA to review
Pre-Market Approval applications.
As per the statues of the 515i program, there is no change to the current
510(k) clearance for Impella throughout the remaining steps of the
reclassification process for Non-Roller Type Cardiopulmonary Bypass
Pumps. Following yesterday's Panel recommendation, the next steps in the 515i
process include FDA issuance of a Proposed Final Order, followed by a period
of public comment, FDA issuance of a Final Order, and then submission of
Pre-Market Approval applications by manufacturers with devices in the
category. Throughout this series of reclassification steps, Abiomed will
continue to market the Impella family of heart pumps and looks forward to
working with FDA to submit the necessary clinical data under the PMA
application process.
Abiomed will host a conference call on Wednesday, December 12, 2012 at 1:00
p.m. ET to discuss the 515i Reclassification Panel in further detail.
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