Edwards Lifesciences

Edwards Lifesciences (NYSE:EW) shares are down after hours on second-quarter results that missed the consensus forecast on Wall Street, with the cardio device company reducing 2022 guidance amid foreign exchange headwinds and hospital staffing challenges.

The Irvine, California–based company earned $406.4 million, or 65¢ per share, off $1.37 billion for the three months ended June 30, 2022, for a slide of 17% on the bottom line and 0.1% on the top line.

Adjusted to exclude one-time items, EPS were 63¢, a penny behind The Street, where analysts on average expected EPS of 64¢ on $1.4 billion in sales.

“Although hospital staffing remains uncertain, we continue to have confidence in our longer-term outlook,” Edwards Lifesciences CEO Michael A. Mussallem said in a news release. “We remain aggressive investors in research and development and clinical research, and we look forward to sharing new, groundbreaking clinical trial results later this year.”

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Edwards Lifesciences (NYSE:EW) shares are down after hours on second-quarter results that missed the consensus forecast on Wall Street, with the cardio device company reducing 2022 guidance amid foreign exchange headwinds and hospital staffing challenges.

The Irvine, California–based company earned $406.4 million, or 65¢ per share, off $1.37 billion for the three months ended June 30, 2022, for a slide of 17% on the bottom line and 0.1% on the top line.

Adjusted to exclude one-time items, EPS were 63¢, a penny behind The Street, where analysts on average expected EPS of 64¢ on $1.4 billion in sales.

“Although hospital staffing remains uncertain, we continue to have confidence in our longer-term outlook,” Edwards Lifesciences CEO Michael A. Mussallem said in a news release. “We remain aggressive investors in research and development and clinical research, and we look forward to sharing new, groundbreaking clinical trial results later this year.”

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Edwards Lifesciences (NYSE:EW) posted fourth-quarter earnings at the end of trading today that fell short of the consensus forecast on Wall Street, but reaffirmed its outlook for 2022.

The Irvine, California-based heart device company reported profits of $335.3 million — or $0.53 per diluted share — on sales of $1.33 billion for the three months ended Dec. 31, 2021, for a bottom-line gain of 8% and sales growth of 12% compared with Q4 2020.

Transcatheter aortic valve replacement (TAVR) sales grew to $872 million for the quarter, up 12% despite the “pronounced impact on hospital resources in December” from the omicron variant of COVID-19, said CEO Mike Mussallem, who cited the delta variant wave in the company’s third-quarter results.

Get the full story at our sister site, Medical Design & Outsourcing.

Edwards’ Evoque system. [Image from Edwards]Edwards Lifesciences (NYSE:EW) shared data from a clinical trial showing that its Evoque transcatheter tricuspid valve replacement offers favorable patient outcomes.

Irvine, California–based Edwards presented the data during the late-breaking clinical science session at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), according to a news release.

The study evaluated 132 patients (56 patients with six-month follow-up) treated with Evoque for symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR), despite optimal medical therapy at six months. It demonstrated TR reduction by core laboratory assessment, with 100% of patients experiencing none/trace or mild TR in 43 patients with paired echocardiographic data available.

Evoque also significantly improved functional and quality of life outcomes, including 89% of patients in NYHA Class I or II, and a 27-point increase in …

Edwards Lifesciences (NYSE: EW) reported third-quarter financial results today that exceeded Wall Street’s expectations on profits but narrowly missed on sales.

The Irvine, California–based cardio device company reported earnings of $340.1 million (or 54¢ per share) off sales of $1.31 billion. That’s a 4.6% increase from Q3 2020’s earnings of $325.2 million (52¢ per share) off sales of $1.14 billion.

Edwards reported TAVR sales of $858 million, which were up 15 percent from the same three months a year ago. Edwards said transcatheter aortic valve replacement (TAVR) sales would have been higher if not for continued pressure on hospitals from COVID-19. The company said TAVR sales outside of the U.S. grew approximately 20 percent on a year-over-year basis.

“Although we experienced the encouraging signs of patient confidence and continued willingness to seek medical care in July, the Delta variant had a significant impact on hospital resources during the las…

Edwards Lifesciences’ Sapien 3 Ultra TAVR [Image courtesy of Edwards Lifesciences]Multiple components go into a catheter delivery system, with several ways to combine them. An Edwards Lifesciences senior R&D director goes over potential pitfalls.

A catheter is a tube that can deliver devices or pharmaceuticals into the body. It is also commonly used for diagnostic purposes. A catheter has a hub or a handle on its end that can connect to a syringe or something that actuates a device.

There are a number of catheter delivery systems currently on the market that deploy devices such as heart pumps, balloons, stents and other clot-busting products.

The catheters need to be small enough to fit through the blood vessels and flexible enough to navigate the human body’s complex cardiovascular system.

Sean Chow, a senior director of R&D at Edwards Lifesciences, told Medical Design & Outsourcing about three pitfalls that creators of catheter-based de…