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Edwards Expects New TAVR Approval In Mid-2025 To Boost Sales

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Edwards Lifesciences predicted Wednesday that an expanded indication in transcatheter aortic valve replacement (TAVR) and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.

Edwards anticipates mid-2025 approval for TAVR in people with asymptomatic severe aortic stenosis, the company said  during an investor day event.

The Sapien TAVR system is Edwards' biggest product but has seen growth slow this year as hospital heart teams dealt with capacity constraints. Hospitals, however, are investing to increase capacity and avoid delays in patient treatment, which will support prioritization of aortic stenosis cases long term, Edwards said in its presentation. 

The company expects approval for TAVR in asymptomatic patients to drive growth, after study results released in October showed benefits of early intervention with the procedure. Asymptomatic patients with severe aortic stenosis who received a Sapien valve had better outcomes in the trial than those who remained under routine clinical surveillance.

Edward executives see the data leading to revised treatment guidelines, which currently recommend clinical surveillance for patients without symptoms.

The company is also studying TAVR in patients with moderate aortic stenosis in the Progress trial. That study completed enrollment earlier this year, two years ahead of schedule, and a data release is targeted for the Transcatheter Cardiovascular Therapeutics conference in late 2026.

Longer term, Edwards executives said the company is developing a catheter-based treatment for aortic regurgitation, which it called the "next frontier" in aortic valve disease. Regurgitation is when blood leaks backward through the valve because it doesn't close properly, whereas stenosis occurs when the valve opening narrows and restricts blood flow.

Beyond TAVR, Edwards is looking for fast growth in sales of its new devices to address mitral and tricuspid valve disease, driven by the Pascal mitral repair system and Evoque for tricuspid valve replacement.

The company expects to gain the CE mark in mid-2025 for Sapien M3, a transcatheter mitral valve replacement system, followed by U.S. Approval in the first half of 2026. If approved in Europe, the device would become the first transcatheter mitral valve replacement system on the market. A pivotal trial is also underway studying Pascal in tricuspid patients.

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Heart failure management is another focus. Edwards' Cordella implantable pulmonary artery pressure sensor received U.S. Approval in June, and the company is now building its commercial team and training doctors on the system.

For 2025, Edwards forecast TAVR sales will increase by a range of from 5% to 7%, excluding the impact of foreign currency fluctuations, to a range of from $4.1 billion to $4.4 billion. The outlook assumes TAVR for asymptomatic patients is approved mid-year.

Sales in transcatheter mitral and tricuspid therapies (TMTT) were projected to rise by a range of from 50% to 60%, to between $500 million and $530 million.

Edwards expects total sales growth of from 8% to 10% in 2025, the same rate it forecasts for 2024. It is targeting 10% average annual growth beginning in 2026.

In TMTT, Edwards said sales could hit $2 billion by 2030.

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CMS Proposes Medicare Coverage For Transcatheter Tricuspid Replacement

The Centers for Medicare and Medicaid Services issued a proposed decision memo on Thursday for Medicare to cover transcatheter tricuspid valve replacement devices. The decision could benefit Edwards Lifesciences, which is seeking a national coverage determination for its Evoque heart valve.

The CMS proposed coverage for patients with severe, symptomatic tricuspid regurgitation, a condition where the tricuspid valve doesn't close properly, allowing blood to leak back into the heart's left atrium. The agency also plans to use its Coverage with Evidence Development program, which allows for Medicare coverage of a treatment on the condition that data is gathered through a clinical trial or registry to determine its effectiveness.

The CMS proposed that studies should consider all-cause mortality or hospitalizations through a minimum of 24 months.  

Edwards' Evoque device is an artificial valve made of cow tissue attached to a self-expanding metal frame. The procedure is conducted using a catheter, intended as an alternative to open-heart surgery. Edwards received Food and Drug Administration approval for the device in February and requested a national coverage determination later that month. 

Edwards said the proposed national coverage determination provides a pathway for access to the technology and that it will submit a public comment, company spokesperson Loree Bowen wrote in an emailed statement on Friday.

Daveen Chopra, leader of Edwards' transcatheter mitral and tricuspid therapies unit, told investors in October that the company hopes to see a draft national coverage determination for Evoque by the end of year and a final decision in the first quarter.

Evoque became eligible for Medicare's new technology add-on payment (NTAP) in October, allowing certain hospital centers to receive payments above standard reimbursement, CEO Bernard Zovighian told investors. The NTAP would be in effect for three years.

Chopra added that the national coverage determination "will help determine which patients and which centers do Evoque, and which patients would get reimbursed. The NTAP helps increase the amount of payment for each patient when they do a case."

In comments submitted to the CMS during the summer, some physicians and consumer advocacy group Public Citizen called for the agency to convene a Medicare Evidence Development & Coverage Advisory Committee meeting before issuing a coverage decision. They raised concerns about the unblinded nature of Edwards' pivotal Triscend II study, as well as the fact that the treatment group had a 27.4% rate of major adverse events after 30 days.

Other physicians, who participated in studies of the device, called for coverage of Evoque. An interventional cardiologist at Piedmont Heart Institute wrote, "Our patients have done dramatically well."

The CMS is seeking public comment on the proposed decision memo through Jan. 18, 2025.

Editor's note: This article has been updated with comments from Edwards.

Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference

NEW YORK, December 04, 2024--(BUSINESS WIRE)--Edwards Lifesciences Corporation (NYSE: EW) will discuss the company's focused strategy for long-term sustainable growth, provide an update on its technology pipeline to serve more patients and share financial guidance today during its annual investor conference. Edwards enters 2025, its first full year as a purely structural heart company, in a strong position with major growth drivers in Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral and Tricuspid Therapies (TMTT), the continued long-term performance of Surgical, and future opportunities with Structural Heart Failure and Aortic Regurgitation (AR).

"It is an exciting day for Edwards as we share our vision for 2025 and how our talented team and focus in structural heart is enabling us to help even more patients," said Bernard Zovighian, Edwards' CEO. "We are projecting another year of strong total company sales growth of 8 to 10 percent. We have significant opportunities to grow TAVR and are proud to continue our deep commitment to advancing science and streamlining care for aortic stenosis patients. Our vision for TMTT has developed into a growth portfolio of differentiated technologies. In Surgical, we continue to see strong global adoption of our premium RESILIA technologies."

Zovighian continued, "In 2026 and beyond, strong total company sales growth will be driven by meaningful catalysts with the potential to change aortic stenosis treatment, including EARLY TAVR and the expected successful outcome from the FDA-approved PROGRESS pivotal trial. TMTT's portfolio of life-changing therapies including PASCAL, EVOQUE and SAPIEN M3 will drive multiple years of rapid growth, while AR and Structural Heart Failure will address two new significant patient opportunities."

Topics to be discussed at today's conference include:

Transcatheter Aortic Valve Replacement (TAVR) – Edwards' TAVR is positioned for strong sustainable growth as many patients remain undiagnosed, untreated or experience treatment delays. The company's SAPIEN platform of TAVR valves remains the category leader and the best-in-class therapy for lifetime management of aortic stenosis.

"The future of TAVR remains strong driven by greater awareness, patient access, advances in new technologies, as well as indication expansion and increased global adoption," said Larry Wood, Edwards' CVP and Group President, Transcatheter Aortic Valve Replacement and Surgical.

Upcoming milestones include:

Strong global adoption of the SAPIEN 3 Ultra RESILIA system

Transformation of patient care stemming from EARLY TAVR, a pivotal trial studying the treatment of patients with severe aortic stenosis without symptoms

Advancement through the follow-up process of PROGRESS, the fully enrolled pivotal trial studying the treatment of moderate aortic stenosis patients

Transcatheter Mitral and Tricuspid Therapies (TMTT) – Edwards is revolutionizing care for the millions of patients suffering from mitral and tricuspid valve diseases. The company has successfully commercialized a unique portfolio of differentiated therapies, including PASCAL and EVOQUE. At the same time, the company remains committed to its strategy of transformative product innovation, robust and expanding clinical evidence to support approvals and adoption, as well as comprehensive support to ensure excellent real-world patient outcomes.

"Continued progress across our unique portfolio of life-changing mitral and tricuspid therapies will result in more patients diagnosed and treated, and a significant long-term growth opportunity," said Daveen Chopra, Edwards' CVP, Transcatheter Mitral and Tricuspid Therapies.

Upcoming milestones include:

Commercialization in the U.S. And Europe of the EVOQUE tricuspid valve, including the recently approved larger 56mm valve

Continued global expansion of the PASCAL Precision system

CE Mark for SAPIEN M3, the world's first transcatheter mitral valve replacement system, remains on-track for mid-year 2025, with U.S. Approval in H1 2026

Completion of follow-up in CLASP IITR, a pivotal trial studying PASCAL for tricuspid patients

Surgical – Edwards remains committed to advancing its leadership in surgical therapies. The company is focused on identifying and solving critical unmet needs in cardiac surgery to help patients live longer, healthier and more active lives. In 2025, Edwards will continue to drive adoption of its RESILIA portfolio, the new standard of tissue durability, including INSPIRIS, MITRIS and KONECT. Also in 2025, Edwards will continue to expand access to its best-in-class surgical innovations in emerging markets to help benefit millions of patients worldwide.

Structural Heart Failure – During 2025, Edwards plans to build a foundation for growth in Implantable Heart Failure Management, a meaningful long-term opportunity for patients suffering from heart failure. With the recent U.S. Approval of the Cordella system, an implantable pulmonary artery pressure sensor allowing advanced heart failure management, Edwards will focus on building its commercial team and deploying physician training and case support to ensure high quality outcomes.

Transcatheter Aortic Valve Replacement (TAVR-AR) – Edwards will invest to accelerate the development of Aortic Regurgitation (AR) therapies to enable earlier patient access. AR is a deadly undertreated disease that currently has no catheter-based option. As the pioneers in valve innovation, Edwards is well-positioned to lead this next frontier of aortic valve disease treatment and expects this to be the beginning of a long-term, iterative strategy similar to TAVR.

2025 Guidance

Sales

$5.6 - $6.0 billion

(8% - 10% constant currency growth)

TAVR

$4.1 - $4.4 billion

(5% - 7% constant currency growth)

TMTT

$500 - $530 million

(50% - 60% constant currency growth)

Surgical

$970 million - $1.05 billion

(mid-single digit constant currency growth)

FX Impact on Sales

~$100 million unfavorable

(~2pt downside to reported growth)

Adjusted Gross Profit Margin

78% - 79%

Adjusted Operating Margin

27% - 28%

Tax Rate

15% - 18%

Adjusted EPS

$2.40 - $2.50

Diluted Shares Outstanding

585 – 595 million

In addition to Zovighian, Wood and Chopra, other members of Edwards' management team presenting include:

Todd Brinton, M.D., F.A.C.C., Chief Scientific OfficerDiane Gomez-Thinnes, CVP, Implantable Heart Failure ManagementWayne Markowitz, SVP, SurgicalScott Ullem, Chief Financial Officer

The conference will also include a session with:

Michael Mack, MD, Director of Cardiothoracic Surgery at Baylor Scott & White Health – Dallas, Texas.Carrie Redick, RN, MSN, NEA-BC, Director of Interventional Cardiology and Structural Heart at Atlantic Health Systems – Morristown, N.J.

Clinical perspectives will also be provided by:

TAVR

Philippe Généreux, MD, Interventional Cardiology, Gagnon Cardiovascular Institute, Morristown Medical Center – Morristown, N.J.Brian R. Lindman, MD, MSCI, Interventional Cardiology, Vanderbilt Health – Nashville, Tenn.Mark Russo, MD, MS, Cardiac Surgery, Robert Wood Johnson Medical School – New Brunswick, N.J.David A. Wood, MD, Interventional Cardiology, University of British Columbia Hospital – Vancouver, Canada

TMTT

Suzanne V. Arnold, MD, MHA, Interventional Cardiology, University of Missouri-Kansas City School of Medicine – Kansas City, Mo.Charles Davidson, MD, Interventional Cardiology, Northwestern Medicine – Evanston, Ill.Rebecca T. Hahn, MD, Interventional Cardiology, New York-Presbyterian Hospital – New York, N.Y.Susheel Kodali, MD, Interventional Cardiology, Columbia Medical Center – New York, N.Y.Raj Makkar, MD, Interventional Cardiology, Smidt Heart Institute – Los Angeles, Calif.Rahul P. Sharma, MBBS, FRACP, Interventional Cardiology, Stanford Healthcare – Stanford, Calif.Thomas E. Waggoner, DO, Interventional Cardiology, Tucson Medical Center – Tucson, Ariz.Firas Zahr, MD, Interventional Cardiology, Oregon Health & Science University Hospital – Portland, Ore.

Surgical

Gorav Ailawadi, MD, MBA, Cardiac Surgery, University of Michigan – Ann Arbor, Mich.Pavan Atluri, MD, Cardiothoracic Surgeon, Hospital of the University of Pennsylvania – Philadelphia, Penn.Ismail El-Hamamsy, MD, PhD, Cardiac Surgery, Mount Sinai – New York, N.Y.Derek MacDonald, MD, Cardiothoracic Surgeon, Sudbury Regional Hospital – Sudbury, CanadaRichard J. Shemin, MD, Cardiothoracic Surgeon, UCLA Health – Los Angeles, Calif.Vinod Thourani, MD, Cardiac Surgery, Piedmont Heart Institute – Atlanta, Ga.

Implantable Heart Failure Management

Dr. Liviu Klein, MD, MS, Director of Advanced Heart Failure, UCSF – San Francisco, Calif.

Conference Call and Webcast Information

The investor conference can be accessed via live webcast at ir.Edwards.Com beginning at 8:30 a.M. Eastern Time today. The presentations will be available on the Edwards website. The webcast will be archived on the "Investor Relations" section of the Edwards website at ir.Edwards.Com or www.Edwards.Com.

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.Edwards.Com and follow us on LinkedIn, Facebook, Instagram and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "potential," "predict," "early clinician feedback," "expect," "intend," "guidance," "outlook," "optimistic," "aspire," "confident" or other forms of these words or similar expressions and include, but are not limited to, statements made by Messrs. Zovighian, Wood, and Chopra, statements in the highlights of today's conference section, full year 2024 financial guidance and financial guidance for 2025, 2026 and beyond, long-term growth catalysts in 2025, statements regarding the strength of the future of TAVR, long-term growth opportunity, increase in more diagnosed and treated patients, high-quality outcomes, CMS national coverage determination expectations, the RESILIA tissue technology, the global adoption of TAVR, and TAVR and TMTT milestones, and statements regarding transforming patient treatment, approvals, pivotal trials, clinical outcomes and adoption. No inferences or assumptions should be made from statements of past performance, efforts, or results which may not be indicative of future performance or results. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain, difficult to predict, may be outside of the company's control and may be subject to the satisfaction of certain customary conditions. The company's forward-looking statements speak only as of the date on which they are made and the company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the company does update or correct one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include risk and uncertainties associated with clinical trial or commercial results or new product approvals and therapy adoption; unpredictability of product launches; competitive dynamics; changes to reimbursement for the company's products; the company's success in developing new products and avoiding manufacturing and quality issues; labor and employment markets; the impact of currency exchange rates; the timing or results of R&D and clinical trials; unanticipated actions by the U.S. Food and Drug Administration and other regulatory agencies; unexpected litigation impacts or expenses; and other risks detailed in the company's filings with the Securities and Exchange Commission (SEC). These filings, along with important safety information about our products, may be found at edwards.Com.

Edwards, Edwards Lifesciences, the stylized E logo, ALLIANCE, CLASP, CLASP II, Cordella, EARLY TAVR, EVOQUE, INSPIRIS, MITRIS, PASCAL, PASCAL Precision, PROGRESS, RESILIA, SAPIEN, SAPIEN M3, SAPIEN X4, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

___________________[1] Guidance for underlying sales growth and adjusted earnings per share are provided on a non-GAAP basis, adjusted for special items described below, due to the inherent difficulty in forecasting such items without unreasonable efforts. The Company is not able to provide a reconciliation of these non-GAAP guidance to comparable GAAP measures due to the unknown effect, timing and potential significance of special charges or gains, and management's inability to forecast charges associated with future transactions and initiatives.

To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles ("GAAP"), the Company uses non-GAAP financial measures. Management makes adjustments to the GAAP measures for items (both charges and gains) that (a) do not reflect the core operational activities of the Company, (b) are commonly adjusted within the Company's industry to enhance comparability of the Company's financial results with those of its peer group, or (c) are inconsistent in amount or frequency between periods (albeit such items are monitored and controlled with equal diligence relative to core operations).

The Company uses the term "underlying" or "organic" growth rate when referring to non-GAAP sales information as adjusted for items referenced in (a) – (c) above, which in the future may exclude, as applicable, items such as foreign exchange rate fluctuations, sales return reserves associated with product upgrades, and proforma sales results of business acquisitions and divestitures. The Company uses the term "adjusted earnings per share" which may in the future also exclude intellectual property litigation income and expenses, amortization of intangible assets, fair value adjustments to contingent consideration liabilities arising from acquisitions, impairments of long-lived assets, the purchase of intellectual property, realignment expenses, and the impact from implementation of tax law changes and settlements.

View source version on businesswire.Com: https://www.Businesswire.Com/news/home/20241204753811/en/

Contacts

Media Contact: Amy Hytowitz, 949-250-5070Investor Contact: Mark Wilterding, 949-250-6826

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