Edwards Lifesciences tricuspid valve reduced leakage in 98% of patients

Edwards Lifesciences‘s Evoque tricuspid valve replacement system reduces tricuspid heart valve leakage to non-traceable or mild leakage in 98% of patients, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session.

Evoque is designed to replace native tricuspid valves without open-heart surgery. The valve is implanted using a minimally invasive delivery system where a doctor places a thin tube through a vein in the leg to reach the patient’s heart and perform the valve replacement procedure.

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

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MedTech 100 roundup: New heights reached again

One week after recording its all-time best performance, the medtech industry once again topped itself, storming even further ahead.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has been on the rise since April began, with last week’s mark of 112.25 (April 16) representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index has already bested itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week.

The rapid improvement continues to shine a light on the strong position the industry has maintained more than a year on from the height of the COVID-19 pandemic’s impact on medtech. The industry has produced a 24.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 84.4% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall markets fared di…

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Edwards rises after hours on Street-beating Q1

Edwards Lifesciences (NYSE:EW) shares ticked up after hours today on first-quarter results that topped the consensus forecast.

The Irvine, Calif.–based company posted profits of $338.2 million, or 54¢ per share, on sales of $1.22 billion for the three months ended March 31, 2021, for an 8.9% bottom-line gain on sales growth of 7.8%.

Adjusted to exclude one-time items, earnings per share were also 54¢, 7¢ ahead of Wall Street, where analysts were looking for sales of $1.2 billion.

Edwards’ transcatheter aortic valve replacement (TAVR) business reported growth of 7% in sales year-over-year, with its Sapien 3 Ultra platform performing well. In December, the company projected 15%-20% growth for TAVR sales in 2021 and reaffirmed that estimate in a news release today.

“We recognize that there are many people still struggling with the pandemic around the world, yet as we anniversary the start of the pandemic, I’m encouraged by the signs…

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4 innovative devices delivered through catheters

[Images from Boston Scientific, Abbott, Edwards Lifesciences and Medtronic]Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular.

They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to keep up with the medtech industry’s growing demand for smaller devices for larger patient populations.

Throughout 2020, we saw a number of FDA clearances and approvals for catheter-based technologies, including ones designed for conditions renal denervation and heart failure. Just a few months into 2021, the FDA has approved catheter-based innovations by two major medtech companies. Two others developed for high-risk patients are worth revisiting.

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8 medical device companies that beat the COVID-19 pandemic and prospered

[Image from unsplash.com]Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread.

Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was actually up for eight of the 20 companies.

For many of the eight companies that saw sales increase, there was a common theme: They pivoted their focus to the diagnostics imaging and personal protective equipment needed to against COVID-19.

“We had different kinds of companies that were able to benefit on some level from COVID and shutdowns,” Richard Newitter, senior research analyst at SVB Leerink, told MDO.

Overall, medtech sales declined in Q1 and Q2 but then bounced back in a V-shaped recovery for the rest of the year, according to Newitter “It plateaued and actu…

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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.

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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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