FDA: a new recognition for Abiomed
- Posted by: Massimo Delle Donne
- Category: Cardiovascular, News
A new and important recognition has been received by Abiomed, leading healthcare company and consolidated partner of Gada. Impella CP, left ventricular assist device, has received FDA approval for its use in coronary angioplasty procedures. Received also for another important Abiomed product as Impella 2.5, this recognition joins to PMA of April 2016 obtained for cardiogenic shock therapy (Post-ima, post cardiotomy) and miocardic recovery.
Impella CP and Impella 2.5 are the only medical devices recognized by FDA as ”safe and effective” for use during high-risk PCI procedures and for patients in cardiogenic shock. This result confirms the quality and the safe of healthcare technologies distributed by Gada in Italy.