Edwards Lifesciences beats the Street in Q1 and increases sales outlook

Edwards Lifesciences (NYSE: EW) + reported first-quarter results that exceeded Wall Street expectations after market close today.

The maker of catheter-delivered heart implants — including transcatheter aortic valve replacement (TAVR) systems and transcatheter mitral and tricuspid therapies (TMTT) — also increased its full-year sales guidance. EW’s stock price was relatively flat in after-hours trading.

Irvine, California–based Edwards Lifesciences earned nearly $351 million, or 58¢ per share, off of $1.6 billion in revenue during the quarter that ended March 31, 2024. Compared to Q1 2023, sales were up 9% year over year and profits increased 3%.

Adjusted to exclude one-time items, earnings per share were 66¢. The result beat the expectations of The Street, where analysts predicted EPS of 64¢ and revenue of $1.57 billion.

“Edwards is positioned to extend our leadership and deliver sustainable …

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Edwards reports ‘excellent’ outcomes with Sapien TAVR

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

Edwards Lifesciences (NYSE: EW) + announced positive results from two real-world studies evaluating its Sapien transcatheter aortic valve replacement (TAVR) system.

Results came from the TVT Registry data and continued to demonstrate strong outcomes. Edwards presented the data at Cardiovascular Research Technologies (CRT) 2024.

A study of the latest TAVR technology, the Sapien 3 Ultra Resilia valve found lower rates of paravalvular leak (PVL) at 30 days when compared to the Sapien 3 and Sapien 3 Ultra valves. Results also showed lower echo-derived gradients and larger effective orifice areas across all valve sizes.

Edwards’ second study showed that its small Sapien TAVR valves demonstrate equal outcomes at three years compared to larger Sapien valve sizes.

“These real-world data further add to the robust body of evidence on the…

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TAVR, Critical Care drive Edwards to Q4 sales beat

Edwards Lifesciences (NYSE: EW) + shares dipped slightly today on fourth-quarter results that topped the consensus sales forecast.

Shares of EW fell 0.2% to $88.11 in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.3%.

The Irvine, California-based company posted profits of $369.9 million. That equals 61¢ per share on sales of $1.53 billion for the three months ended Dec. 31, 2023. Edwards recorded a 7.2% bottom-line slide on sales growth of 13.8%.

Adjusted to exclude one-time items, earnings per share came in at 64¢, equaling projections on Wall Street. Sales narrowly topped expectations, as analysts forecasted $1.5 billion in revenue.

TAVR and Critical Care sales drove the revenue beat, with growth of 13% and 11% in those segments, respectively. Critical Care sales growth is particularly noteworthy, g…

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Edwards wins FDA approval for its Evoque replacement tricuspid valve

The Evoque tricuspid valve replacement system. [Image courtesy of Edwards Lifesciences]Edwards Lifesciences (NYSE: EW) + announced today that the FDA granted approval for its Evoque tricuspid valve replacement system.

The company says this makes Evoque the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation (TR). Irvine, California-based Edwards won CE mark for the Evoque system in October 2023. That approval also marked a first in Europe and globally.

Edwards can now offer Evoque for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy for whom tricuspid valve replacement is deemed appropriate by a heart team.

“Edwards has a long history of leading innovation and pioneering new therapies to address the unmet needs of patients with structural heart disease. “We are grateful for the strong collaboration with clinicians all over the wor…

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Edwards plans to spin off critical care business next year

Edwards Lifesciences (NYSE: EW) + announced today that it intends to spin off its critical care business by the end of 2024.

The company shared a number of key plans going forward as it outlined its plans for future growth. Among its plans, Edwards expects to spin off the critical care unit and its full range of smart monitoring technologies next year.

“During 2024, Edwards plans to support the growth and leadership of innovations in advanced patient monitoring, with the goal of improving the quality of care for millions of patients annually,” Edwards wrote in a news release.

Analysts expect shares of Edwards to move up on the news today. Shares of EW rose 1% at $70.17 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remained even.

Edwards intends to complete the spin-off tax-free. The co…

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The biggest cardiovascular stories from TCT 2023

Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT.

This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco.

Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE HealthCare and more had positive updates on their own technologies.

Last year’s TCT event highlighted some significant trends in the cardiovascular space. Let’s see what this year’s symposium brought.

Abbott’s TriClip, MitraClip shine along with drug-eluting stent

Results from Abbott’s TRILUMINATE pivotal trial reinforced the safety and effectiveness of the TriClip system. Abbott also shared data from the MitraClip EXPAND G4 real-world registry at TCT 2023.

TriClip, a transcatheter edge-to-edge repair (TEER) system, treats patients with symptomat…

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Edwards wins CE mark for Mitris Resilia valve

The Mitris Resilia valve. [Image courtesy of Edwards Lifesciences]Edwards Lifesciences (NYSE: EW) + announced today that it received CE mark approval for its Mitris Resilia tissue valve replacement.

News of the latest regulatory milestone follows the receipt of CE mark approval for the Evoque valve system last week. Edwards also reported positive TAVR data at TCT 2023 and recorded third-quarter sales growth in its latest earnings report.

The company designed this valve, made with bovine pericardial tissue technology, specifically for the heart’s mitral position. Bovine tissue technology reduces calcium build-up on the valve, preserving and protecting the tissue. It allows the valve to potentially last longer than conventional bioprosthetic valves.

Mitris Resilia features a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. Edwards based its low-profile valve on the Perimoun…

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State of the industry — Execs ‘more bullish than ever’ on medtech

From left: Kevin Lobo, Lisa Earnhardt, Deepak Nath, Bernard Zovighian. All spoke about the state of the industry at The MedTech Conference.

Ernst & Young’s 2023 Pulse of the Industry medical technology report may not have been overly positive, but medtech executives certainly are.

The EY report highlighted sluggish revenues and post-COVID-19 corrections leading to a growth decline. In fact, it was the lowest growth in medtech since 2015. Roughly half of medtech stock price gains realized in 2021 were wiped out by the end of 2022.

However, leading medtech executives, including Stryker CEO Kevin Lobo, only see upwards.

“I feel as bullish as I’ve ever felt in my time in medtech,” Lobo declared.

Lobo, Abbott EVP of Medical Devices Lisa Earnhardt, Smith+Nephew CEO Deepak Nath and Edwards CEO Bernard Zovighian all have positive outlooks for the space. They outlined their views on a panel based around the EY report Monday at T…

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Report: Edwards is cooperating with EU amid antitrust scrutiny

According to reports, Edwards Lifesciences (NYSE: EW) + is the company under scrutiny in Europe for potential antitrust activity.

Reuters reports that the company is working with EU antitrust regulators on the matter. The European Commission said last week that it conducted a surprise inspection at an undisclosed medtech company. It listed that company as active in the cardiovascular space, an area in which Edwards operates. Edwards is one of the market leaders in replacement heart valves, including transcatheter aortic valve replacement (TAVR) technology.

The report says Edwards confirmed itself to Reuters as the company inspected by the European officials. Edwards’ statement to the outlet said it is cooperating with the European Commission and remains confident in its business practices. The company also reportedly told Reuters that it remains committed to healthy, fair competition.

According to a news r…

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Edwards software may reduce duration, severity of hypotension, study says

Edwards Lifesciences (NYSE: EW) + today announced study results that support the use of its Acumen HPI software.

Results from the EU-HYPROTECT registry indicate that using Acumen HPI may help reduce the duration and severity of intraoperative hypotension in patients having non-cardiac surgery. In June, Edwards shared results from the registry that also demonstrated the software’s success.

The company developed Acumen HPI to provide clinicians with information regarding the likelihood of a patient developing hypotension. The software uses an algorithm that calculates data from hemodynamic monitoring in perioperative management. It then leverages predictive analytics to alert clinicians of potential blood pressure drops before they occur.

Acumen HPI received FDA 510(k) clearance in June 2022.

The European, multicenter, prospective, observational registry included 702 patients in its final analysis. Th…

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TAVR sales were up 9% for Edwards in Street-beating Q2

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

Edwards Lifesciences (NYSE: EW) + shares fell after hours today despite second-quarter results that beat the consensus forecast.

Shares of EW dipped 6.3% to $85.85 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 0.6%.

The Irvine, California-based company posted profits of $307.1 million. That equals 50¢ per share on sales of $1.53 billion for the three months ended June 30, 2023.

Edwards recorded a 24.4% bottom-line slide on sales growth of 11.4%.

Adjusted to exclude one-time items, earnings per share came in at 66¢. That snuck in 1¢ ahead of expectations on Wall Street, where analysts projected sales of $1.5 billion.

“We are pleased to report strong second quarter double-digit sales growth while a…

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Study says Edwards software could help reduce hypotension

Edwards Lifesciences (NYSE:EW) today announced results from a registry demonstrating the effect of software on reducing hypotension.

The EU-HYPROTECT registry evaluated patients having non-cardiac surgery. Results indicated that the Edwards Acumen HPI software may help reduce the duration and severity of intraoperative hypotension.

Edwards said the European multicenter prospective observational registry included, in its final analysis, 702 patients. These patients, scheduled for elective major non-cardiac surgery, spanned 12 medical centers in France, Germany, Italy, Spain and the UK. The company said it marks the first multicenter registry involving a predictive monitoring technology. It establishes a large, prospectively college database on hypotension management in patients undergoing non-cardiac surgery. All patients had intraarterial blood pressure monitoring with an arterial catheter and intraoperative Acumen HPI software.

Edwards developed its Acu…

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