Edwards Lifesciences (NYSE:EW) shares are recovering a bit today — a day after the stock took a nearly 5% slide after a Jefferies report suggested a potential step down in TAVR sales in December. The Jefferies model showed a sharp step down in December growth (–2% to +3%) from October and November (+27–28%). The result was […]
Abbott wins MitraClip patent spat with Edwards — for now
The U.S. Patent Trial and Review Board (PTAB) this week shot down an attempt by Edwards Lifesciences (NYSE:EW) to invalidate the patents that Abbott (NYSE:ABT) holds on its MitraClip transcatheter mitral valve repair (TMVR) device. In a ruling published Thursday, the PTAB said Edwards failed to show that it would prevail in with at least one […]
The 10 greatest medtech advances of the 2010s
From disposable endoscopes to TAVR to robotic surgery, there’s a whole host of medtech advances widely available now that weren’t around much 10 years ago. “In terms of technological advances, I would put this past decade as one of the most important for medical technology. From connected devices and robotics, to advances in material sciences […]
Report: FDA has nonpublic list of TAVR-related deaths
The FDA has yet another private listing of device-related deaths, this one for transcatheter aortic valve replacement (TAVR) devices that include Medtronic’s (NYSE:MDT) CoreValve and Edwards Lifesciences’ (NYSE:EW) Sapien 3 lines, according to a new report by Kaiser Health News. Both devices were initially indicated for patients who were too frail or ill for open-heart surgery, but the FDA subsequently approved […]
Edwards projects $5 billion in sales for 2020
Wall Street expressed brief unhappiness with projections made at today’s Edwards Lifesciences (NYSE:EW) annual investor conference in New York, but shares had recovered partially by the close of trading. The Irvine, Calif.-based heart valve replacement pioneer projected adjusted EPS of $6.05 to $6.30 on global sales of $4.5 billion to $5 billion for 2020. Edwards […]
Edwards IDs issue with Cardioband injuries
Edwards Lifesciences (NYSE:EW) has notified providers of a higher-than-expected rate of injuries during deployment of its Cardioband mitral/tricuspid valve reconstruction system (TMVR). Approximately 5.7% of patients treated with Cardioband suffered coronary artery injuries, most “as a result of direct interaction between the anchors of the Cardioband device and coronary arteries running adjacent to the valve […]
Edwards issues recall for Pascal guide sheaths
Edwards Lifesciences (NYSE:EW) issued a product recall for its guide sheath used with the Edwards Pascal transcatheter valve repair system. The company is recalling all lots of the product after it identified potential for damage to the Pascal guide sheath’s inner line due to a manufacturing issue. Edwards found that the issue has occurred in 0.5% […]
Report: FDA still hiding reports of patient deaths
This article has been updated with a response from Boston Scientific. The FDA is apparently allowing medtech companies to submit incomplete reports of device-related deaths, according to a new report by the StarTribune of Minneapolis. The news article says that the agency accepted one summary report covering four deaths related to Boston Scientific’s (NYSE:BSX) Watchman […]
Edwards’ Sapien 3 TAVI wins expanded approval in Europe
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%. […]
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