Edwards Lifesciences (NYSE:EW) said today that it won 510(k) clearance from the FDA for a smart cable to connect a brain oxygenation sensor with its HemoSphere patient monitor. The clearance covers the ForeSight tissue oximeter the Irvine, Calif.-based company acquired in the $98 million buyout of Casmed last April. “Understanding the relationship between the heart and […]
Edwards Lifesciences slides after FDA slaps Class I on Sapien 3 Ultra recall
Edwards Lifesciences (NYSE:EW) shares slid today after the FDA slapped Class I status on last month’s recall of its Sapien 3 Ultra replacement heart valve. Irvine, Calif.-based Edwards in July warned doctors about the risk of burst balloons during implantation of the transcatheter aortic valve replacement, cautioning physicians to closely follow the instructions for use to […]
BREAKING: FDA approves TAVR valves for low-risk patients
The FDA today expanded the approval for replacement heart valves made by Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) to include patients at low risk from open heart surgery. The expanded transcatheter aortic valve replacement approvals, for Medtronic’s CoreValve Evolut R and CoreValve Evolut Pro and Edwards’s Sapien 3 and Sapien 3 Ultra devices, widens the potential […]
Edwards Lifesciences abandons Centera self-expanding TAVR for Sapien 3 Ultra push
Edwards Lifesciences (NYSE:EW) is discontinuing work on its Centera TAVR system as it increases focus on expanding indications for its Sapien 3 Ultra valve. The news — which came yesterday with the company’s second-quarter earnings announcement — comes weeks after an urgent field safety notice in which the company warned customers that it had received reports […]
Edwards jumps on Q2 sales & earnings beat, raised outlook
Edwards Lifesciences (NYSE:EW) shares jumped after hours today on second-quarter results that topped the consensus forecast. The Irvine, Calif.-based heart valve replacement pioneer posted profits of $242.3 million, or $1.14 per share, on sales of $1.09 billion for the three months ended June 30, for a -14.3% bottom-line slide on sales growth of 15.2%. Adjusted to exclude […]
The 17 most innovative medical devices of 2019
The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
Edwards Lifesciences warns on burst balloon risk with Sapien 3 Ultra heart valve
Edwards Lifesciences (NYSE:EW) warned doctors about the low risk of burst balloons during implantation of its Sapien 3 Ultra replacement heart valve, cautioning physicians to closely follow the instructions for use to avoid the problem. The Irvine, Calif.-based medical device maker’s latest iteration of its transcatheter aortic valve replacement won CE Mark approval in the European […]
Edwards warns on tracking issue reported with Centera TAVR
Edwards Lifesciences (NYSE:EW) issued an urgent field safety notice this week warning customers that it received reports of difficulty tracking and manipulating its Centera TAVR system around the aortic arch. The company said that the issue has caused vascular injury including aortic dissection and death during early cases. The observed incidence of serious events related to […]
Deaths prompt Class I recall for Edwards Lifesciences IntraClude balloon
The FDA, prompted by multiple reports that the Edwards Lifesciences (NYSE:EW) IntraClude balloon burst that included three deaths, yesterday gave the device’s recall Class I status. The IntraClude device is designed to occlude the aorta during cardiopulmonary bypass procedures. Last month, Irvine, Calif.-based Edwards put out a field safety notice about the high-risk balloon bursts, which […]
CMS expands TAVR coverage
The Centers for Medicare and Medicaid Services have updated the criteria for hospitals and physicians to begin or continue providing transcatheter aortic valve replacement surgery. The decision gives hospitals and providers more flexibility to meet the CMS requirements for performing TAVR, the agency said Friday. The original National Coverage Determination (NCD) for TAVR procedures was cleared in […]
Edwards Lifesciences warns on risk of IntraClude balloon bursting
Edwards Lifesciences (NYSE:EW) issued a field safety notice warning users that its IntraClude balloon could burst during cardiopulmonary bypass. The high-risk balloon burst could cause injury, according to the company. When the balloon bursts, the heart can fill and warm and obscure the operative site. Edwards Lifesciences says the device needs to be exchanged or operate […]
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