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 […]
Edwards Lifesciences warns against below-market mini-tender offer
Edwards Lifesciences (NYSE:EW) yesterday advised its investors against joining in an unsolicited “mini-tender offer” by TRC Capital Corporation, which is looking to purchase approximately 1 million shares of the company’s stock. The Irvine, Calif.-based company said it does not endorse the offering and recommended that its stockholders “reject the offer” either by doing nothing in response […]
Report: Healthcare CEO pay balloons to $2.6B, quality of care not a factor in bonuses
Healthcare chief execs at 177 top companies collectively saw their compensation grow to $2.6 billion last year while quality of care and improvements to healthcare spending remained at most a marginal factor to their pay, according to an Axios analysis. Despite a focus on pharmaceutical CEOs, medical device company chief execs were five of the […]
Edwards adds $1B to share repurchase program
Edwards Lifesciences (NYSE:EW) said that its board of directors authorized an additional $1 billion for stock repurchases, according to a recently posted SEC filing. The Irvine, Calif.-based company said that with the additional allocation, it now has a total of $1.3 billion remaining under its share repurchase program. In the same SEC filing, the company also […]
UK court shoots down Abbott bid for injunction in TMVR patent spat with Edwards
Edwards Lifesciences (NYSE:EW) recently claimed a win in a UK-based patent spat with Abbott (NYSE:ABT) over IP related to each company’s respective transcatheter mitral valve repair devices after a UK court shot down a bid from Abbott for a preliminary injunction. In the suit, filed on January 28, Abbott claimed that Edwards is infringing on two of […]
FDA: Edward’s select recall of Miller, Fogarty atrioseptostomy caths is Class I
The FDA has classified a select recall of Edwards Lifesciences (NYSE:EW) Miller and Fogarty atrioseptostomy catheters over balloon deflation, fragmentation and detachment issues as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Miller Balloon catheter […]
Edwards Lifesciences post Street-beating Q1 earnings
Shares in Edwards Lifesciences (NYSE:EW) fell slightly today despite the medical device maker posting Street-beating first quarter earnings results that saw the growth on the bottom line of over 20%. The Irvine, Calif.-based company posted profits of $249.7 million, or $1.18 per share, on sales of $993 million for the three months ended March 31, for […]
Edwards Lifesciences closes $98m CAS Medical Systems buyout
Edwards Lifesciences (NYSE:EW) yesterday closed the $98 million acquisition of CAS Medical Systems and its non-invasive brain tissue oxygenation monitoring tech. Irvine, Calif.-based Edwards paid $2.45 per share for Branford, Conn.-based Casmed using cash on hand, for an aggregate value of $98.1 million, Casmed said in a regulatory filing. The deal was announced Feb. 12. The […]
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