Edwards Lifesciences (NYSE:EW) said today that it received CE Mark approval for expanded use of its Sapien 3 transcatheter aortic valve implantation (TAVI) system. The expanded use if for treatment of patients with aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 TAVI is the first transcatheter heart valve system to win […]
These 10 medtech companies care a lot about research
These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal year. We […]
Edwards jumps on Q3 sales & earnings beat, raised outlook
Edwards Lifesciences (NYSE:EW) shares jumped during the pre-market hours today on third-quarter results that topped the consensus forecast. The Irvine, Calif.-based heart valve replacement pioneer posted profits of $274.7 million, or $1.30 per share, on sales of $1.09 billion for the three months ended Sept. 30, for a 21.6% bottom-line gain on sales growth of 20.7%. […]
Edwards Lifesciences to put $100m into Costa Rica expansion
Edwards Lifesciences (NYSE:EW) is slated to add a $100 million expansion and 500 new jobs by the end of 2020 in an effort to expand its operations in Costa Rica, according to the Costa Rican Investment Promotion Agency. The Irvine, Calif.-based company established cardiac device manufacturing facilities in Cartago in 2016, announcing a plan to add […]
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
TCT 2019: Boston Scientific slides on Acurate Neo TMVR trial miss
The Acurate Neo replacement heart valve being developed by Boston Scientific (NYSE:BSX) failed to show non-inferiority in a head-to-head comparison with the Sapien 3 valve made by Edwards Lifesciences (NYSE:EW), according to study data released at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. The 739-patient Scope I study randomized increased-risk patients to either Acurate Neo […]
FDA OKs smart cable for Edwards Lifesciences brain oxygenation sensor
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 […]
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