Edwards Lifesciences Archives - Page 2 of 7

Study backs Edwards aortic valve with Resilia tissue

Edwards Lifesciences (NYSE:EW) today announced new data from a clinical trial evaluating bioprosthetic aortic valves with its Resilia tissue.

Data from the COMMENCE aortic trial demonstrated low rates of structural valve deterioration (SVD) in the bioprosthetic valves. It represents the longest clinical follow-up for Edwards’ valve with Resliia tissue at a mean of 7.7 years. The company presented data today at the 103rd annual meeting of the American Association for Thoracic Surgery.

Resilia, a bovine pericardial tissue treated with anti-calcification technology, serves as the platform for Edwards’ new class of valves. Edwards launched the Sapien 3 valve with Reslia in September 2022. The company is using it while developing the next-generation Sapien X4 valve, which is currently undergoing clinical trials.

The build-up of calcium may cause SVD, potentially impacting the long-term durability of bioprosthetic valves. Edwards says. It designed heart …

Edwards beats The Street in Q1, raises 2023 guidance to up to 12% sales growth

Edwards Lifesciences (NYSE: EW) + shares dipped despite first-quarter results that topped the consensus forecast.

Shares of EW were down slightly to $86.72 apiece by the close of trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up slightly.

The Irvine, California–based medical device maker yesterday evening posted profits of $340.5 million. That amounts to 56¢ per share on sales of $1.46 billion for the three months ended March 31, 2023.

Edwards posted an 8.9% bottom-line slide on sales growth of 8.8%. The company attributed the reduction in profits to a less favorable impact from foreign exchange. TAVR sales grew 8% to $948 million, while Edwards’ structural heart revenues grew by 12%. Critical care sales ticked up 5%.

The company noted that overall valve surgery growth came in higher than expected.<…

The biggest cardiology tech stories from ACC.23

Medtronic, Abbott, iRhythm and more presented new data at a major cardiology conference, ACC.23. [Images courtesy of Medtronic, Abbott and iRhythm] Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space.

Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans.

Ablation, cardiac implants, monitors and imaging technology represented a handful of the technologies on display. Medtronic, Abbott, Boston Scientific, Edwards and more offered new data on their innovative technologies in these areas.

Here are some of the biggest stories that came out of the cardiology conference.

Excitement builds around using pulsed-field ablation to treat AFib

Medtronic, Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster all released new…

Edwards Lifesciences finds low re-intervention rates at 10 years for TAVR patients

Edwards Lifesciences (NYSE:EW) today announced data supporting transcatheter aortic valve replacement (TAVR) at 10 years.

An analysis of Medicare data showed a low rate of re-intervention after TAVR out to 10 years. Dr. Suzanne Baron, a Boston-based interventional and structural cardiologist, led the analysis. Edwards presented results at the American College of Cardiology ACC.23/WCC.

Of 230,644 patients treated with transfemoral and transapical TAVR between 2011 and 2021, only 1,880 underwent valvular re-intervention. This translated to a 1.63% rate of re-intervention overall when considering the competing risk of death.

Edwards also said it observed the apparent decrease of re-intervention rates with the introduction of next-generation TAVR technologies.

“The observed, sustained low re-intervention rates as well as the decrease in re-interventions with advanced technology are particularly impactful and provide valuable input into the decis…

New medtech to watch for in 2023: boosting health outcomes

[Image from Pixabay]As earnings season is upon us, we’re receiving a clearer view of what new medtech could be launching this year in the medical device space.

Companies still feel hamstrung by macroeconomic pressures, supply chain issues and more. However, many pointed out that 2023 has plenty to look forward to. Several quarterly reports and earnings calls included positive outlooks for the year ahead, with plenty of companies banking on significant revenue growth and other successes.

For many, that comes down to some new medtech product launches. Here are a few picked out from earnings calls and other announcements that you might want to look out for:

Abbott

On Abbott’s earnings call last month, CEO Robert Ford pointed to product launches as a major part of its outlook for 2023.

Abbott said it expects to log adjusted EPS of between $4.30 and $4.50. Excluding COVID-19-related sales, the company expects high-single-digit revenue growth.<…

5 reasons you should feel good about medtech companies in 2023

[Image from Pixabay]“Macroeconomic headwinds” is a phrase repeated a lot these days, but a string of positive medtech company earnings reports this week should cheer medical device industry insiders.

The medical device industry may once again prove that it’s an economically resilient space.

“While 2022 brought its share of supply chain and inflationary pressures, directionally, many companies note easing within the supply chain, lessening inflationary impacts, healthy capital demand, and improving procedural recovery. We think as these dynamics take shape through 2023, MedTech’s outlook and subsequent sector performance in the market will improve,” BTIG analyst Ryan Zimmerman told MassDevice via email.

Investors are finally looking past a lot of the macro challenges, according to Mike Matson, a senior research analyst at Needham & Co.

“While the medtech industry isn’t out of the woods yet, things have started t…

Edwards stock up on Street-beating Q4

Edwards Lifesciences (NYSE:EW) stock is up today — a day after the company announced fourth-quarter results that beat the consensus forecast.

Shares of EW were up more than 3% at $79.63 apiece by late morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up more than 11%.

The Irvine, California–based company posted profits of $398.4 million in the quarter. That amounts to 65¢ per share on sales of $1.35 billion for the three months ended Dec. 31, 2022.

Edwards recorded an 18.8% bottom-line gain on sales growth of 1.4%.

Adjusted to exclude one-time items, earnings per share came in at 64¢ apiece. That lands Edwards 3¢ ahead of projections on Wall Street. The company posted a sales beat, too, as analysts expected $1.33 billion in revenue.

While TAVR sales remained flat year over year, Edwards reported 1% growth for its structural heart busin…

The biggest medtech stock gainers, losers in 2022

(From Ishant Mishra on Unsplash) In another roller coaster year for medtech, these are the companies that saw their stock rise and fall the most drastically.

The MassDevice MedTech 100 Index, which includes stocks of the world’s largest medical device companies, reflects the performance of many in the medtech space.

In a tough year for a lot of businesses, the Index wasn’t immune to struggles. Overall, it dropped 27.3% from this time last year. That compares to a 19.7% drop for the S&P 500 and an 8.9% dip for the Dow Jones Industrial Average.

Some businesses, though, powered through the supply chain- and inflation-related woes to see their stock rise from this time last year. Others weren’t so lucky. Here are some of the biggest gainers and losers — selected from the MedTech 100 Index — of 2022.

Biggest gainers BD — $245.27 to $254.97 — Up 4%

While BD (NYSE:BDX) didn’t have the most significant growth, its stock remains in a …

The top 10 cardiac device stories of 2022

[Image from Pixabay]From pulsed-field ablation to non-invasive monitoring, this was an exciting year for cardiac device tech.

Here are the top 10 cardiac device stories from MassDevice and its sister sites:

10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio

Earlier this year, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million.

9. Abbott confirms first implants of its dual-chamber leadless pacemaker system

The company designed its i2i technology to provide beat-by-beat communication between two leadless pacemakers, with one positioned on the right ventricle and the other in the right atrium.

8. Boston Scientific completes $1.75B Baylis Medical acquisition

The deal expanded Boston Scientific’s electrophysiology and structural heart product portfolios to include the radiofrequency (RF) NRG and VersaCross transseptal platforms. It also gained a family of guidewires, sheaths an…

Edwards Lifesciences CEO to step down next year

Edwards Lifesciences (NYSE:EW) announced today that Michael A. Mussallem, chair and CEO, intends to retire next year.

Mussallem, 70, informed the board of his decision to retire in connection with Edwards’ annual meeting of stockholders on May 11, 2023.

At that meeting, Mussallem intends to stand for election as non-executive chair of the Edwards Board. The company’s succession plan tabbed Bernard Zovighian to succeed him as CEO. Zovighian currently serves as corporate VP and GM of Edwards’ transcatheter mitral and tricuspid therapies (TMTT) business.

Zovighian takes over as president, effective Jan. 1, until he becomes CEO in May. Edwards plans for him and Mussallem, along with the board and executive leadership team, to work closely to ensure a smooth transition.

“It has been a special honor and privilege to lead our team at Edwards Lifesciences for more than 20 years in their immense contributions to helping and advancin…

Edwards announces positive results for Evoque valve replacement system

The Evoque transcatheter tricuspid valve replacement system. [Image from Edwards Lifesciences]Edwards Lifesciences (NYSE:EW) announced that one-year results from the TRISCEND study demonstrated favorable outcomes.

TRISCEND, a single-arm, prospective, global, multi-center study, evaluates the Edwards Evoque system. Evoque, a transcatheter tricuspid valve replacement system, demonstrated favorable safety, efficacy and quality-of-life outcomes.

Edwards presented data during the late-breaking trials session at PCR London Valves 2022.

Patients enrolled in the trial had symptomatic moderate or greater functional or degenerative tricuspid regurgitation (TR). They had TR despite optimal medical therapy. The trial enrolled 176 patients. Edwards said in a news release that this represents the largest dataset among transcatheter tricuspid valve replacement therapies.

The company earlier reported positive 30-day and 6-month results. One-year outcomes demonstrate…

Edwards triggers $750M share repurchase program

Edwards Lifesciences (NYSE:EW) announced today that it executed an accelerated share repurchase agreement (ASR) worth $750 million.

Irvine, California-based Edwards’ ASR consists of the repurchasing of its common stock. With the transaction, Edwards repurchased more than $1.7 billion in its own shares in 2022.

Under the ASR terms, the company received an initial delivery of approximately 8 million shares. The remainder arrives at the maturity of the ASR. Edwards said the final number of repurchased shares relies upon the volume-weighted average share price during the agreement term.

The company plans to fund the share repurchase under the ASR with its existing cash. Edwards said that, following the repurchase, it has approximately $900 million remaining in its share repurchase authorization.

Edwards’ share repurchase comes less than a week after its stock took a hit on third-quarter financial results. EW shares fell more than 18% to $7…