Edwards Lifesciences has temporarily paused new enrolments in its active pivotal clinical trials of its transcatheter mitral and tricuspid therapies in response to ongoing COVID-19 pandemic. A press release reports that the company is coordinating closely with the trials’ clinical investigators at the relevant hospital. It adds that the decision to resume enrolments in [...]
Source: BIBA MedTech Insights TAVI Tracker The TAVI market in Western Europe grew by 19.2% between Q3 2018 and Q3 2019. Over the last three years, Edwards Lifesciences (the market leader) lost market share while Medtronic and Boston Scientific both gained market share. Boston Scientific’s acquisition of Symetis in Q2 2017 helped [...]
Sapien 3 Edwards Lifesciences has received the CE mark for its Sapien 3 transcatheter aortic valve implantation (TAVI) device to be used to manage aortic stenosis in low-risk patients. Both Edwards and Medtronic (with its CoreValve Evolut range) have FDA approval for their devices to be used for low-risk patients in the [...]
Edwards Lifesciences has issued a recall for the guidesheath (model number: 10000GS and 10000GSCE) that is used in conjunction with the Pascal system for the transcatheter repair of mitral valve regurgitation. According to a letter sent to physicians, there is a potential for damage to the inner liner of the guidesheath because of a [...]
The FDA has issued a Class I recall—which it describes as “the most serious type of recall”—for the delivery system of the Sapien 3 Ultra transcatheter aortic valve implantation (TAVI) system. The recall follows Edwards Lifesciences receiving reports of burst balloons during implantation procedures, and it comes just under a week after the FDA [...]
The FDA has approved Evolut R, Evolut PRO (Medtronic), Sapien 3 and Sapien 3 (Edwards Lifesciences) for the management of low-risk patients with severe aortic stenosis. The approval follows the publication—in the New England Journal of Medicine—of two studies that showed positive results with these devices in low-risk patients. Prior to the FDA approval, [...]
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 [...]
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 [...]