JenaValve Technology announced that it raised $50 million in equity financing as it develops and manufactures the JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for treating aortic valve disease. Bain Capital Life Sciences led the funding round, while Andera Partners, Gimv, Legend Capital, NoMed Management, RMM, Valiance Life Sciences and VI Partners all participated, […]
Edwards Lifescience boosts 2020 guidance amid strong TAVR sales
Edwards Lifesciences (NYSE:EW) saw its stock jump in after-hours trading today after the company boosted its 2020 guidance amid positive fourth-quarter TAVR sales. The Irvine, Calif.–based cardio device and critical care monitoring company’s Q4 results were mixed. But there was also the news that worldwide TAVR sales were up 30% year-over-year in Q4, to $763 million, […]
Edwards Lifesciences stock takes a hit on TAVR report
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 […]
JenaValve TAVR wins FDA breakthrough device designation
JenaValve Technology said today that FDA has granted breakthrough device designation for its JenaValve Pericardial TAVR. The designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. It means that FDA will provide the Irvine, Calif.–based company with priority review and interactive communication regarding device development and clinical trial protocols. “We are […]
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 […]
Medtronic faces patent lawsuit over CoreValve tech
A decade-old company called Colibri Heart Valve is claiming in a lawsuit that Medtronic’s CoreValve line of TAVR devices are infringing on two of its patents. Founded in 2010, Broomfield, Colo.–based Colibri boasts that its TAVI system is the only one using dry tissue technology to allow for a pre-mounted, pre-crimped, and pre-loaded heart valve, […]
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 […]
Mick Jagger is giving TAVR a boost: Here’s how
A successful transcatheter aortic valve replacement (TAVR) recovery for rock icon Mick Jagger could be good news for companies such as Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) that make devices for the procedure, according to analysts following the medical device industry. The Rolling Stone frontman tweeted Friday that he was feeling better and on the […]
This new technique could make TAVR more available
A novel technique could prevent coronary artery obstruction — a rare but often fatal complication related to transcatheter aortic valve replacement (TAVR), according to the National Institutes of Health researchers who created it. The researchers at NIH’s National, Heart, Lung, and Blood Institute are calling the procedure Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA). […]
3 secrets of medtech success from a true industry pioneer
From stents to TAVR, Stanton Rowe has built a medtech legacy out of accomplishing the seemingly impossible. Here are three lessons from his career. Stanton Rowe has played a major role in two of the top medtech innovation success stories of recent decades: stents and transcatheter valve replacements. Listening to him speak at DeviceTalks West […]
Edwards Lifesciences has ‘key events’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark […]
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