Edwards Lifesciences

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…

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 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.<…