Edwards Lifesciences Archives - Page 6 of 7

TAVR sales growth was flat in July, Jefferies reports

Edwards Lifesciences’ Sapien 3 Ultra TAVR [Image courtesy of Edwards Lifesciences]

Jefferies equity research reported that sales of transcatheter aortic valve replacement (TAVR) are better than the previous quarter with flat growth.

Edwards Lifesciences (NYSE:EW) reported among its second-quarter results that TAVR sales had taken a -12% hit for the three months ended June 30, 2020. When the company reported its quarterly results, it noted that it had seen cases of people holding off on heart valve replacement because they are worried about potentially catching COVID-19.

Jefferies currently has Edwards’ TAVR growth ranging from -7.5% to 2.0%, falling roughly in line with the -2% to 0.6% in consensus. According to the analysts’ report, the company’s third-quarter results are looking to fall in the consensus range.

While the third quarter looks to be an improvement over Edwards’…

Medtech and COVID-19: 7 things you need to know

[Photo by Sasha • Stories on Unsplash]

When COVID-19 set upon the U.S. in March, medtech executives only had a month at most to explain to analysts in quarterly calls how the pandemic was hitting their companies — not nearly enough time to understand the long-term impact.

Three more months have passed since those quarterly calls, and we’re now wrapping up a new earnings season. While no one can be 100% sure what the future will hold, medtech executives’ comments — and their companies’ actions — are shedding some light on changes coming to the medtech industry.

Here are seven insights we’ve gleaned at Medical Design & Outsourcing and MassDevice from the latest medtech earnings season.

Next>> Listen to us discuss all 10 points during our latest DeviceTalks Weekly podcast>>

Executive editor Chris Newmarker contributed to this report.

DTW Podcast: 10 ways medtech is finding its footing amid COVID-19

When COVID-19 set upon the U.S. in March, medtech executives had a month at most to tell Wall Street analysts how the pandemic had hit the industry’s largest companies. We heard about short-term hits in revenues, procedures and employee headcounts, but uncertainty clearly ruled the day.

Over the past few weeks, medtech executives from several leading companies reported back to analysts with a full quarter under their belt. To be sure, no one can claim to hold a full grasp on this crisis, but a survey of the calls reveals steps and adjustments that companies are taking to thrive beyond the pandemic.

In this podcast, we’ll list our Top 10.

Don’t miss an episode! Subscribe to DeviceTalks Weekly on your podcast players. It’s available on Apple Podcasts, Spotify and other podcast channels.

DeviceTalks by MassDevice · Ten ways medtech companies are finding their footing during the pandemic

Dems seek to force EPA action on ethylene oxide monitoring

(Image from the U.S. Occupational Safety and Health Administration)

Democrats in both houses of Congress have introduced legislation that would force the U.S. Environmental Protection Agency to better monitor emissions of ethylene oxide (EtO) from plants that manufacture the toxic gas or use it to sterilize medical devices.

The Public Health Air Quality Act of 2020, sponsored by Sen. Tammy Duckworth (Ill.) and Rep. Lisa Blunt Rochester (Del.), would require immediate EPA action to monitor emissions at “facilities contributing to high local cancer rates and other health threats from dangerous pollutants.” The list includes eight medtech sterilization plants included among 25 EPA-designated, EtO-using or -producing facilities:

Get the full story on our sister site, Medical Design & Outsourcing.

MedTech 100 roundup: Industry remains on the rise

The medtech industry continues to climb back up in the markets, following a landmark week with another move up toward its pre-COVID-19-pandemic highs.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.29 points at the end of last week (July 24). That total represents just a -3.3% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

On July 22, the index reached 90.11 points, marking its highest point since that pre-pandemic high and the first and only time it has eclipsed 90 points since that day in February.

Medtech stocks saw a 0.44% increase from the 88.9-point total at the same time a week prior (July 17), highlighting a slight improvement after last week saw the industry inch back toward that pre-pandemic high.

Meanwhile, the S&P 500 Index saw a -0.3% decline from July 17 to July 24, and the Dow Jones Index fared slightl…

DTWeekly Podcast: Can Drawbridge, Edwards bring disruptive innovation to blood drawing, heart surgery industries?

In this week’s podcast, we talk with Holly Logue, general counsel at Drawbridge Health, about the OneDraw, an innovative new tool that might upend the collecting, storage and testing of blood. Logue, a panelist in the upcoming DeviceTalks Tuesdays sponsored by Finnegan, will explain how her past work on Capitol Hill is helping this Silicon Valley company’s plans.

Meanwhile, we speak with Daveen Chopra, corporate vice president of surgical structural heart at Edwards Lifesciences, about that company’s commitment to treating the most serious cardiac patients. The company recently won FDA approval for its Konect Resilia aortic valve conduit, a vital new tool in helping heart patients, including many requiring emergency story.

Co-costs Tom Salemi, editorial director of DeviceTalks, and Chris Newmarker, executive editor of life sciences at MassDevice, review the five biggest news stories of the week. We’ll talk about Abbott, Becton Dickinson, Boston Scientific…

The 18 most innovative medical devices of 2020

The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release. “The awards committee applauds the nominees for their commitment to ensure a healthier future for generations to come.”

Get the full story on our sister site, Medical Design & Outsourcing.

The top 5 medtech stories of the week — July 24, 2020

COVID-19 is surging back in the U.S., new jobless claims are up, but MassDevice’s most-read stories this week were mostly optimistic.

That’s the takeaway from our inaugural MassDevice Top Five — a weekly recap of the most-read stories on MassDevice, the online business journal of the medical device industry. Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast.

Without further ado, here’s this week’s MassDevice Top Five:

5. Better than expected results from Edwards Lifesciences

Officials at Edwards Lifesciences (NYSE:EW) had warned that it was going to be a tough Q2 amid the COVID-19 pandemic. Sure enough, it was. But the Irvine, Calif.–based artificial heart valves and hemodynamic monitoring company results still beat Wall Street expectations — with the company even upping its earnings guidance for the year. “Irrespective of the unpre…

Edwards Lifesciences Q2 results are better than expected

Edwards Lifesciences (NYSE:EW) stock has jumped in after-hours trading after the company reported Street-beating Q2 results and boosted it earnings outlook.

The Irvine, Calif.–based artificial heart valves and hemodynamic monitoring company reported a loss of –$122 million, or –20¢ per share, off $925 million in revenue during the quarter ended June 30. For the same quarter a year ago — before the COVID-19 pandemic — Edwards saw profits of $242 million, or 38¢ per share, off $1.087 billion in revenue.

Sales of TAVR — a hot area in medtech — took a 12% hit.

The results, though, beat predictions. Adjusted to exclude one-time items, earnings per share were 34¢, double the expectations of The Street, where analysts were looking for EPS of 17¢ on sales of $797.5 million.

Healthcare providers have been working to ensure the safety of people without COVID-19 who are coming in for care, but Edwards Lifesciences has still seen cases of people holding off o…

MedTech 100 roundup: Industry hits pandemic peak

After five months since medtech stocks peaked before the COVID-19 pandemic rocked the markets, the industry inched back toward that pre-pandemic high.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 88.9 points at the end of last week (July 17). That total represents just a -3.7% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Medtech stocks saw a 5.1% increase from the 84.39-point total at the same time a week prior (July 10), highlighting a large improvement after last week saw almost no material change in the index.

Meanwhile, the S&P 500 Index saw a 1.2% bump from July 10 to July 17, and the Dow Jones Index fared even better, posting a 2.3% increase over the same period of time. Both indexes mirrored the medtech industry’s changes as far as increases, but didn’t see as drastic a change.

Medtech’s lowest point du…

FDA approves Edwards Lifesciences’ ready-to-implant aortic valved conduit

The Konect Resilia aortic valved conduit (AVC) [Image courtesy of Edwards Lifesciences]

Edwards Lifesciences (NYSE:EW) announced today that FDA has approved its Konect Resilia aortic valved conduit (AVC).

Edwards describes the Konect Resilia as the first ready-to-implant option for bio-Bentall procedures, a complex surgery that involves the replacement of a person’s aortic valve, aortic root and the ascending aorta.

Surgeons find themselves having to perform nearly a third of Bentall procedures in an emergency setting.

“Until now, surgeons did not have a pre-assembled option that was FDA approved, so those utilizing bovine tissue valves for Bentall procedures needed to manually assemble a valve with a conduit in the operating room,” said Dr. Joseph Bavaria, surgery professor and vice chief of the division of cardiovascular surgery at the University of Pennsylvania.

“…

BREAKING: Abbott, Edwards settle heart device patent spats

Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) said this afternoon that they have agreed to settle all outstanding patent disputes related to transcatheter mitral and tricuspid repair products, and Edwards has made an one-time payment of $368 million to Abbott, according to an SEC filing.

The agreement will result in the dismissal of all pending cases or appeals in courts and patent offices worldwide, and includes a provision that the parties will not litigate patent disputes with each other in the field of transcatheter mitral and tricuspid repair and replacement products for the next 10 years. Any injunctions currently in place will be lifted.

A judge in England issued an injunction in April barring Edwards from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K. Judge Colin Birss of the High Court of England and Wales also ruled that two patents held by Abbott unit Evalve for its MitraClip TMVR device were valid and that Edwa…