Edwards Lifesciences misses in Q2, lowers guidance

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 misses in Q2, lowers guidance

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 shares fall on Street-beating Q1 results

Edwards Lifesciences (NYSE: EW) posted first-quarter results today that beat the consensus forecast on Wall Street and reaffirmed its outlook for the rest of the year, with CEO Michael Mussallem saying “we are hopeful the worst of the pandemic is behind us.”

That may have sounded too much like a jinx for superstitious stocktraders as COVID-19 cases in the U.S. are climbing once again after a brutal winter. Investors reacted to the financial results by sending EW shares down more than 5% to $110.00 in after-hours trading.

Before Edwards released its results, the stock dropped about 3% on the day, compared to a 2.5% decline in MassDevice and MDO‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies.

The Irvine, California–based cardio device company reported profits of $373.6 million, or $0.59 per diluted share, on sales of $1.34 billion for the three months ended March 31, 2022. That was a 10% increase in b…

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FDA approves Edwards Lifesciences’ tissue valve replacement for heart’s mitral position

Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Mitris Resilia tissue valve replacement system.

Irvine, California-based Edwards designed the Mitris Resilia valve with a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. It features a low-profile frame for avoiding obstruction of the left ventricular outflow tract by stent posts and is visible under fluoroscopy to facilitate potential future transcatheter interventions.

According to a news release, the Mitris Resilia valve represents Edwards’ latest product offering advanced Resilia (bovine pericardial) tissue with an anti-calcification technology allowing devices to be stored under dry packaging conditions for improved ease of use.

Edwards has studied Resilia in two pre-market clinical trials, combining outcomes for a total of 904 patients and more than 3,800 patient years of follow-up that support the tissue replacement platform.

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Edwards Lifesciences misses on Q4 earnings as omicron hammers hospitals

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.

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FDA approves Edwards Lifesciences Sapien 3 with Alterra for pulmonary regurgitation

Edwards’ Sapien 3 transcatheter heart valve (Image from Edwards Lifesciences)

Edwards Lifesciences (NYSE:EW) announced today that it received FDA approval for the use of its Sapien 3 transcatheter valve with the Alterra adaptive prestent.

Irvine, California-based Edwards garnered the FDA nod for use of the Sapien 3 with Alterra for patients with severe pulmonary regurgitation.

The Sapien 3 transcatheter pulmonary valve (TPV) system combines the Sapien 3 valve and the Alterra adaptive present to expand transcatheter therapy options for congenital heart valve disease patients, Edwards said in a news release. The company designed Alterra to compensate for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the Sapien 3 valve.

Indication for the Edwards Sapien 3 TPV system with Alterra covers the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echoca…

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Baxter, 3M, Abbott near the top of Newsweeks’ most reponsible companies list

Several medtech, healthcare and life sciences companies, including big names like Abbott (NYSE:ABT), 3M (NYSE:MMM) and Baxter (NYSE:BAX), are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined environmental, social and corporate governance performance assessments.

Baxter, 3M, Abbott and BD (NYSE:BDX) were among the highest-ranking big-name medical device makers. Cancer diagnostic company Illumina was the highest-ranking company under the healthcare and life sciences umbrella, sitting in second behind HP.

In sixth sat Baxter, registering an overall score of 89.5 points, with its highest performance coming in environmental i…

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Edwards touts trial results for Evoque transcatheter tricuspid valve replacement system

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 …

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Sapien 3 TAVR offers improved outcomes, reduced cost, Edwards Lifesciences says

Edwards’ Sapien 3 transcatheter heart valve (Image from Edwards Lifesciences)

Edwards Lifesciences (NYSE:EW) today touted a cost-effectiveness analysis that supports transcatheter aortic valve replacement (TAVR) with the Sapien 3.

Irvine, California -based Edwards presented data from the Partner 3 trial during the late-breaking clinical trials at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

According to a news release, the analysis comparing TAVR to surgery demonstrated that TAVR with Sapien 3 represents an economically dominant treatment strategy with improved outcomes and reduced cost. The analysis compared healthcare costs, life expectancy and quality-adjusted life for patients with severe aortic stenosis at low risk for surgery, who were treated with TAVR or surgery in the PARTNER 3 trial.

Partner 3 randomized 1,000 patients across 71 centers between March 2…

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Edwards Lifesciences stock slides on Q3 financial results

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…

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3 pitfalls to consider when creating catheter delivery systems

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…

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MedTech 100 roundup: Industry climbs with earnings season in full swing

The medtech industry remains on the upswing as companies see their stocks rising with quarterly earnings providing a boost.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 30) at 118.86 points. Two weeks ago aside — when the index shot up to 145.88 points and quickly tumbled down — this mark would be the index’s all-time best.

The total at the end of last week represents a 2.9% rise from the 115.54-point tally posted by the index at the end of last week (July 23).

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 28.7% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 91.3% ascent above that point.

The industry’s performance had no cor…

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