Data Presented at TCT Reinforce Edwards Lifesciences’ Commitment to Structural Heart Innovation

Rhea-AI Summary

Edwards Lifesciences (NYSE: EW) presented new clinical data at the Transcatheter Cardiovascular Therapeutics (TCT) conference, emphasizing its commitment to structural heart innovation. The data from the EARLY TAVR and TRISCEND II trials highlighted the importance of early intervention in severe aortic stenosis and the benefits of transcatheter mitral and tricuspid therapies (TMTT). Key findings included improved outcomes and reduced healthcare costs for patients receiving timely treatment. Specific studies showcased the efficacy of TAVR in asymptomatic severe aortic stenosis patients and women, and the long-term benefits of the PASCAL system in treating mitral regurgitation. Additionally, the TWIST study demonstrated promising results for Innovalve in mitral valve replacement. These findings support Edwards' growth and innovation in treating structural heart disease.

Positive

• New clinical data supports early intervention in severe aortic stenosis, reducing healthcare costs.
• EARLY TAVR and TRISCEND II trials show improved outcomes for previously understudied patient groups.
• PASCAL system demonstrates sustained benefits in treating mitral regurgitation.
• TWIST study shows promising outcomes for Innovalve in transcatheter mitral valve replacement.

Negative

• Pre-procedural requirements delay TAVR treatment compared to SAVR, impacting patient access.

Insights

Medical Research Analyst

The clinical data presented at TCT reveals significant advancements in Edwards Lifesciences' structural heart portfolio. The EARLY TAVR trial results demonstrate compelling evidence for treating asymptomatic severe aortic stenosis patients earlier, potentially expanding the addressable market. The TRISCEND II and CLASP IID two-year outcomes validate the durability and effectiveness of Edwards' TMTT technologies.

Key findings show that early intervention in structural heart disease leads to better clinical outcomes and reduced healthcare costs. The meta-analysis and pooled data from RHEIA + PARTNER 3 trials strengthen Edwards' position in the TAVR market, particularly highlighting positive outcomes in women. The PASTE registry data with over 1,000 patients reinforces the commercial potential of PASCAL in the tricuspid valve space.

Market Research Analyst

This comprehensive clinical data strengthens Edwards' market leadership in structural heart therapies and supports potential market expansion. The positive results across multiple trials and patient populations could drive increased adoption of both TAVR and TMTT technologies. The economic value proposition demonstrated through healthcare cost reduction studies will likely appeal to healthcare systems and payers, potentially accelerating market penetration.

The acquisition and successful integration of Innovalve's technology, as evidenced by the TWIST study results, shows Edwards' strategic commitment to expanding its TMTT portfolio. These developments position Edwards well for sustained growth in the structural heart market, particularly in undertreated patient populations.

WASHINGTON--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) today announced significant additions to the body of high-quality evidence presented and published during the Transcatheter Cardiovascular Therapeutics (TCT) conference, addressing the critical needs of patients with structural heart disease.

“The data at TCT on Edwards’ innovations underscore our commitment to scientific leadership and our focus to bring impactful and life-saving structural heart therapies to patients and physicians,” said Bernard Zovighian, Edwards’ CEO. “This new clinical evidence also advances Edwards’ opportunities within both TAVR and TMTT to treat more patients with our advanced technologies and support long-term, sustainable growth across the company in the years ahead.”

The data, including results from the groundbreaking EARLY TAVR and TRISCEND II trials, highlighted outcomes from studies that focused on previously understudied patient groups. The findings emphasized that timely treatment of structural heart disease not only enhances clinical outcomes and quality of life for patients, but also reduces long-term healthcare costs.

Transcatheter Aortic Valve Replacement (TAVR)

New data provided compelling evidence about TAVR, particularly for patients without symptoms but suffering from severe aortic stenosis, including:

• A meta-analysis highlighting the importance of early intervention in asymptomatic severe aortic stenosis patients and reinforcing the results from the EARLY TAVR trial.

• A pooled analysis of RHEIA + PARTNER 3 data highlighting the efficacy and safety of Edwards TAVR in women.

• Insights into delays in care for aortic valve replacement (AVR), finding pre-procedural requirements contribute to TAVR patients waiting significantly longer than SAVR patients to access treatment.

• An assessment of the value of timely treatment of aortic stenosis, finding that intervening at earlier stages of cardiac damage helps save costs and healthcare resources.

Transcatheter Mitral and Tricuspid Therapies (TMTT)

Additionally, new evidence was presented on Edwards’ portfolio of transcatheter mitral and tricuspid repair and replacement therapies, reinforcing the strength of the company’s innovations beyond TAVR, including:

• The two-year outcomes from the pivotal CLASP IID trial, showcasing sustained benefits of PASCAL in treating degenerative mitral regurgitation in a broad patient population.

• An analysis of the healthcare resource utilization and costs associated with tricuspid regurgitation, highlighting the economic impact of timely intervention.

• One-year results from the TWIST global feasibility study, demonstrating promising outcomes for Innovalve in transcatheter mitral valve replacement, which was recently acquired by Edwards.

• Data from the PASTE registry, encompassing more than 1,000 European patients treated with PASCAL in the tricuspid position, underscoring its safety and effectiveness.

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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this release to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr. Zovighian and statements regarding expected product benefits, including safety and efficacy, other benefits including costs and health care resources, patient outcomes, objectives and expectations and other statements that are not historical facts. 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 and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, CLASP, CLASP II, EARLY TAVR, PARTNER, PASCAL, TRISCEND, and TRISCEND II are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241030713206/en/

Media Contact: Amy Hytowitz, 949-250-4009

Investor Contact: Mark Wilterding, 949-250-6826

Source: Edwards Lifesciences Corporation

FAQ

What did Edwards Lifesciences present at the TCT conference?

Edwards Lifesciences presented new clinical data from the EARLY TAVR and TRISCEND II trials, highlighting the benefits of early intervention in severe aortic stenosis and the efficacy of TAVR and TMTT therapies.

What are the key findings from the EARLY TAVR trial presented by Edwards Lifesciences?

The EARLY TAVR trial highlighted the importance of early intervention in asymptomatic severe aortic stenosis patients, showing improved outcomes and reduced long-term healthcare costs.

How does the PASCAL system benefit patients with mitral regurgitation according to Edwards' data?

The PASCAL system has shown sustained benefits in treating degenerative mitral regurgitation, improving clinical outcomes over a two-year period.

What were the results of the TWIST study on Innovalve presented by Edwards Lifesciences?

The TWIST study demonstrated promising outcomes for Innovalve in transcatheter mitral valve replacement, indicating its potential effectiveness and safety.

What impact do pre-procedural requirements have on TAVR treatment?

Pre-procedural requirements contribute to significant delays in accessing TAVR treatment compared to SAVR, affecting patient access to timely care.