Edwards Lifesciences Archives - Page 3 of 7

Edwards Lifesciences misses in Q3 amid economic challenges

Edwards Lifesciences (NYSE: EW) shares are down today — a day after reporting third-quarter results that missed the Wall Street consensus forecast.

EW shares were down more than 18% to $70.49 apiece by the afternoon today. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down more than 1%.

The Irvine, California–based cardio device company saw persistent U.S. hospital staffing shortages and COVID headwinds in Japan affect its TAVR sales. Edwards’ TAVR sales only grew 1% year-over-year in Q3, reaching $862 million.

Edwards Lifesciences earned $343.5 million, or 55¢ per share, off $1.319 billion for the quarter ended Sept. 30, 2022. The results represented just a slight uptick in both the bottom and top lines.

Adjusted to exclude one-time items, EPS were 61¢. The results were a penny behind The Street, where analysts expected EPS of 62¢ on sales of $1.33 billion.

Some …

4 major cardiology trends you need to know from TCT 2022

Medtronic, Edwards and Abbott presented positive data as TAVR, TEER and renal denervation innovations continue to arrive.

The 34th Transcatheter Cardiovascular Therapeutics (TCT) conference took place in Boston this past week and a ton of big names made waves with their technologies and innovations.

Medtronic, Abbott, Edwards and Boston Scientific represent a few of the companies revealing new data for their cardiovascular offerings. ReCor Medical, Abiomed and more got involved, too.

Plenty of the study outcomes represented positive steps forward, while other companies hit speed bumps in their efforts. Here are some of the biggest takeaways from the conference:

1. Renal denervation innovations plug along

Medtronic (NYSE:MDT) announced study data that demonstrates significant blood pressure reduction with the Symplicity renal denervation system.

The RDN minimally invasive procedure delivers radiofrequency energy to specific nerves near the …

Edwards TEER therapy proves safe and effective in head-to-head trial with Abbott MitraClip

Abbott’s MitraClip (left) and Edwards’ Pascal (right)

Edwards Lifesciences (NYSE:EW) announced data confirming its transcatheter edge-to-edge repair (TEER) as safe and effective.

CLASP IID compared Edwards’ Pascal system and Abbott’s MitraClip system. The study determined that the two contemporary TEER therapies are safe and effective in patients with degenerative mitral regurgitation (DMR).

Results from the trial were presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT) and published simultaneously in JACC: Cardiovascular Interventions.

Trial results

Patients enrolled in the CLASP IID pivotal trial had severe symptomatic DMR and were determined to be at a prohibitive surgical risk. The trial met its primary safety and effectiveness endpoints, according to a news release. Pascal demonstrated non-inferiority for safety and effectiveness compared to MitraClip.

In the trial, Pascal demonstrated a low composite…

Edwards wins FDA approval for Pascal Precision transcatheter valve repair system

[Image from Edwards]Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Pascal Precision system for patients with degenerative mitral regurgitation (DMR).

Irvine, California-based Edwards designed its Pascal Precision system for precision transcatheter edge-to-edge repair (TEER) for heart valves.

The system features independent grasping, atraumatic clasp and closure and the ability to elongate. According to a news release, it enables safe and effective treatment for patients with DMR. It includes an intuitive catheter and handle for maneuverability and stability to offer precise navigation and implant delivery.

“Patients suffering with debilitating symptoms as a result of degenerative mitral regurgitation represent a large and significantly underserved group in the US,” said Bernard J. Zovighian, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies. “Edwards’ 60-year history of innovation and…

Edwards launches Sapien 3 Ultra Resilia heart valve following FDA approval

Edwards Lifesciences (NYSE:EW) announced today that it launched its Sapien 3 Ultra Resilia transcatheter heart valve.

Irvine, California-based Edwards launched the valve following recent FDA approval. It incorporates the company’s Resilia tissue technology in the transcatheter aortic valve repair (TAVR) device.

Resilia, a bovine pericardial tissue treated with anti-calcification technology, serves as the platform for Edwards’ new class of valves. The company is using it while developing the next-generation Sapien X4 valve, which is currently undergoing clinical trials.

The tissue provides enhanced calcium blocking properties and dry tissue packaging conditions that facilitate ease of use, Edwards said. It demonstrated freedom from structural valve deterioration at 5 years. Edwards said it has the potential to extend the durability of the Sapien 3 valve.

Sapien 3 Ultra Resilia will be available in the U.S. through a limited rele…

10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

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.”

…

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…

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.

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.

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…