How big medtech fared during a year of COVID-19

[Image from Unsplash]Despite numerous challenges, the medtech industry showed itself to be fairly recession-proof in 2020, according to a Medical Design & Outsourcing/MassDevice analysis of financials.

Annual reports recently released by 20 of the world’s largest medical device companies showed only a slight dip in revenue during 2020 — a year in which medtech held the front lines against the COVID-19 pandemic. Employment was also up slightly amongst the top earners, while R&D spending held its own.

The 20 companies included in the MDO analysis include 3M Healthcare, Abbott (medical device segment), Alcon, Align Technology, Baxter, Boston Scientific, Danaher (life sciences and diagnostics segment), Dentsply Sirona, Edwards Lifesciences, GE Healthcare, Henry Schein, Intuitive Surgical, Johnson & Johnson (medical device segment), Medline Industries, Owens & Minor, Royal Philips, Smith+Nephew, Stryker, Teleflex and Zimmer Biomet.

Get the full s…

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Edwards touts 5-year aortic valve trial results

Edwards Lifesciences (NYSE:EW) announced data showing favorable safety and hemodynamic performance from its Resilia tissue platform.

Data from Edwards’ Commence clinical trial demonstrated that its bioprosthetic surgical aortic valve with the novel Resilia tissue aortic valve platform produced favorable results across a median of five years follow-up, according to a news release.

Commence is a prospective, non-randomized, multicenter, single-arm FDA investigational device exemption trial with 689 patients enrolled across 27 clinical sites in the U.S. and Europe.

The trial evaluated the Resilia tissue aortic valve in patients age 18 and older with diagnosed aortic valve disease who are scheduled to undergo aortic valve replacement surgery. The patients will continue to be evaluated through the 10-year mark.

A key safety outcome was met as there were no incidences of structural valve deterioration (SVD) at the five-year mark, as Resilia tissue…

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MedTech 100 roundup: January ends with a dip

After spending several weeks on the ascent, medtech stocks leveled out a bit to end January, ending a run of several new highs in 2021.

MassDevice‘s MedTech 100 index ended the week (Jan. 29) at 104.05 points, marking a -2.2% drop from the 106.4-point mark set at the end of the previous week (Jan. 22).

The index had previously reached 107.4 points on Jan. 20, topping the all-time best of 106.81 points set on Jan. 8. That mark represents a 16% jump from the pre-pandemic high of 92.32 set on Feb. 19, 2020, and a 72.9% overall leap from the lowest point of 62.13 set on March 23, 2020.

However, the drop from that high point to medtech’s current position is approximately -3.1%, although the industry still remains well above its pre-pandemic high (12.7%) and its mid-pandemic low point (67.5%).

Here are some of the best-performing medtech stocks from 2020.

While medtech saw a slight decline from the previous week, both of the overall markets fared …

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Edwards Lifesciences misses on earnings in Q4

Edwards Lifesciences (NYSE:EW) posted fourth-quarter earnings this evening that missed the consensus forecast on Wall Street, though the company met revenue expectations.

The Irvine, Calif.–based cardio device company reported profits of $309.5 million, or 49¢ per share, on sales of $1.19 billion for the three months ended Dec. 31, 2020, for a bottom-line gain of 10.5% on sales growth of 1% compared with Q4 2019.

Adjusted to exclude one-time items, earnings per share were 50¢, missing –3¢ off The Street, where analysts were looking EPS of 53¢ on sales of $1.19 billion.

Sales were flat for Edwards’ flagship TAVR products, which saw only 2% growth in the quarter as the latest COVID-19 pandemic wave delayed procedures. Overall Edwards sales were up nearly 1%, to $4.386 billion, in 2020.

“Despite unprecedented challenges in 2020, I’m proud of our team’s steadfast dedication to patients and advancing Edwards’ long-term str…

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These medtech stocks performed the best in 2020

(From Ishant Mishra on Unsplash)

While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward.

Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while pivoting to artificial-intelligence-based and remote care.

Companies like Moderna arose from nowhere, climbing from a share price of $19.52 to $104.47 over the course of the year as it established itself as a frontronner in the race to get a COVID-19 vaccine to the public, eventually becoming the second vaccine authorized in the U.S.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has hit new heights over the course of 2020, indicating the upward trajectory of the industry. Over the course of the year, the index grew from a total of $86.8…

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Which TAVR device is the best? It depends, researchers say

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

Researchers published a paper in the Journal of the American Medical Association citing insufficient evidence regarding the superiority of TAVR devices.

Currently, only three TAVR devices are commercially available in the U.S., belonging to Edwards Lifesciences (NYSE:EW), Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX), although several others are being used in clinical trials to evaluate safety and efficacy.

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

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CMS agrees to cover ‘breakthrough’ medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning.

Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

The MCIT pathway would be voluntary and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.

“This coverage pathway d…

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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’…

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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.

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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


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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.

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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…

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