Centera – BIBA Medtech Insights

Edwards Lifesciences drops its self-expanding TAVI valve in favour of focusing on its balloon-expanding range

Source: BIBA MedTech TAVI Monitor Edwards Lifesciences—in a press statement announcing its global second quarter (Q2) financial results—has revealed that it is taking the self-expanding transcatheter aortic valve implantation (TAVI) device Centera off the market. The company says resources will instead be focused on the balloon-expanding Sapien range of TAVI devices, adding [...]

Edwards Lifesciences issues an urgent field safety notice for Centera TAVI system

After receiving reports of difficulty tracking and manipulating the Centera transcatheter aortic valve implantation (TAVI) system around the aortic arch, Edwards Lifesciences has issued an urgent safety notice. The notice states that these difficulties have “resulted in vascular injury including aortic dissection and death during early cases”. It adds: “A thorough investigation of these [...]