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…

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…

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…

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…

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…

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…

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…

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…