New Approval Extends Impella ’s Support Time
Abiomed has received a nod from FDA to expand the Impella 5.0 and Impella LD PMAâs labeling for the treatment of cardiogenic shock. The agency has approved the Danvers, MA-based companyâs Impella to provide support 10 to 14 days.
Prior to the expansion, the pump was only at six days.
Abiomedâs Impella 5.0 and the Impella LD are forward flow heart pumps that deliver up to 5 L/min, stabilizing a patientâs hemodynamics, unloading the left ventricle, and perfusing the end organs, allowing for the potential of native heart recovery or return to heart function baseline.
The Impella 5.0 is implanted through the femoral or axillary artery and the Impella LD is implanted directly into the aorta. Both allow patients to walk around the unit while on support.
In an email, Abiomed told MD+DI âthe expanded approval was based on a review of data in Abiomedâs Impella Quality (IQ) Database. The IQ Database contains real-world data on nearly all Impella cases in the U.S.â
Abiomed won PMA approval for Impella as a safe and effective for the treatment of cardiogenic shock in 2016. This approval was based on an analysis of 415 patients from the RECOVER 1 study and the U.S. Impella registry, and an Impella literature review of 692 patients in 17 clinical studies. Additionally, more than 24,000 Impella patients supported by Impella devices were reviewed in a safe...
Source: MDDI - Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news