Bernard J. Zovighian
Chief Executive Officer and Director at Edwards Lifesciences
Of $1.4 billion increased 10% on a constant currency basis versus the year ago period, slightly ahead of our expectations. TAVR and TMTT both contributed significantly to growth in the third quarter as more patients globally benefited from our catheter-based structural heart therapies.
During the quarter, our team made important advancements in our clinical research and new product introduction to address the unmet needs of structural heart patients around the world. Next week, at TCT, you will hear more about our commitment to generating important clinical evidence to help physicians and the healthcare ecosystem take care of the many patients in need.
At the conference, we will be discussing the pivotal clinical data presentation of EARLY TAVR TRISCEND 2 and CLASP 2D, along with more than 20 other important updates. Edwards is leading the advancement of science in this large, diverse and rapidly growing field.
Our priority remains positioning TAVR for long-term growth. In addition to introducing differentiated next-gen technologies, we are leading several global initiatives, including reaching more patients through patient awareness, activation and access, and enhancing physician training and support programs.
For TMTT, we continue to scale our fast-growing business, and we are pleased with its trajectory over the last several quarters. Key initiatives include broadening the launch of PASCAL, advancing the introduction of EVOQUE in the US and in Europe, and launching SAPIEN M3 in Europe next year. Edwards' unique pipeline of innovation should drive strong multiyear growth.
We are also committed to bringing differentiated surgical innovation to patients supported by strong evidence generation, ensuring we remain at the forefront of surgical advancements. Moreover, we are entering new therapeutic areas, such as aortic regurgitation, or AR, and implantable heart failure management, or IHFM. These initiatives align with our long-term vision of expanding into more therapies, driving sustainable growth for Edwards.
It was especially busy quarter as our team around the world deliver on our strategy. We closed the sale of Critical Care in September, took important actions to sharpen our focus on Structural Heart, including integrating recent acquisition and rightsizing the company for long-term profitable growth.
As we look ahead, we see significant growth opportunities across our differentiated portfolio of leading Structural Heart therapies for TAVR AS, TAVR ER, TMTT, Surgical and IHFM. This commitment will be discussed in detail at the upcoming investor conference where we will outline our strategies for differentiated value creation in the years ahead.
Now, I will provide detail on Q3 results by product group. In TAVR, third quarter global sales of $1 billion increased 6% when adjusted for currency and billing days. Edwards' strong competitive position and pricing remained stable globally, although we experienced a few instances of regional pressure. We are confident in our differentiated technology, high-quality evidence, and the value we continue to demonstrate to patients, clinicians and healthcare systems.
We remain deeply committed to advancing evidence for AS patients. In August, one-year data for the RHEIA trial, a first-of-its-kind trial, focused exclusively on outcomes for women receiving TAVR were presented at the ESC meeting held in London. Investigators reported superior outcome for women receiving the Edwards' SAPIEN 3 or SAPIEN 3 Ultra-valve as compared to those receiving surgical aortic valve replacement for the primary endpoints of death, stroke, rehospitalization at one year.
We are proud of this high-quality clinical research. The outstanding success of TAVR points to the importance of valve selection for women undergoing aortic valve replacement, especially those with small analyze to preserve their option for a future valve-in-valve procedures, ensuring the lifetime management of their disease.
Next week at TCT, the clinical community will hear results from the early TAVR trial. The trial is the first and largest randomized controlled trial to date studying asymptomatic severe AS patients and the impact on -- of early integration with TAVR.
Turning to the US. Our year-over-year third quarter TAVR sales growth rate was in line with our global TAVR constant currency growth rate. We believe our US competitive position was largely unchanged. In the US, although hospitals and physicians continue to acknowledge heart team capacity constraints nationally, it is encouraging that many hospitals are exploring additional investments to address future workflow needs to manage these patients. We know from experience that hospitals have historically demonstrated the ability to scale to support transcatheter procedure growth over time.
Outside of the US in the third quarter, our constant currency TAVR sales growth was in line with our global TAVR growth. In Europe, our market position improved sequentially, supported by the continued launch of SAPIEN 3 Ultra RESILIA. We are pleased with the exceptional patient outcome delivered with this platform. And we expect this momentum to continue as more centers adopt our best-in-class TAVR platform.
Additionally, we received CE Mark approval for our Alterra system for congenital heart patients. Alterra should result in quality of life improvement and a reduction in the number of procedures that these younger patients will require over the lifetime. We have initiated the introduction of its novel therapy in Europe, and initial feedback from clinicians has been positive.
In Japan, slower market growth pressured our results. We remain dedicated to expanding this therapy to address significant undertreatment of AS among the substantial early population in Japan.
In closing, we are pleased with our Q3 TAVR results, which were slightly above our expectation. Our 5% to 7% growth guidance for the full year remains unchanged. However, we expect the Q4 year-over-year sales growth rate to be lower due to some onetime items that Scott will describe later.
We remain confident that Edwards is positioned for healthy and sustainable TAVR growth, driven by our differentiated TAVR technology, our deep commitment to advancing patient care through high-quality clinical evidence, new indication, and our investment in patient activation initiatives.
Last quarter, we announced the acquisition of JC Medical and J-Valve, early innovators in the treatment of AR. These acquisitions provide an opportunity in a new therapeutic area to address the unmet needs of AR patients around the world, a deadly disease that impacts more than 100,000 patients in the US alone and is largely untreated today. As the pioneer in valve innovation, we believe Edwards is best positioned to develop, study and deliver novel technologies.
I am pleased to report that we performed our first implant in the JOURNEY pivotal trial with the Edwards J-Valve AR system recently acquired from JC Medical. As noted in our announcement of the JenaValve transaction, the acquisition is subject to regulatory review and other customary closing conditions. We are responding to a second request from the FTC in connection with their review and anticipate closing the acquisition mid-2025.
Now turning to TMTT. Our unique innovations, including the PASCAL repair system, the EVOQUE tricuspid replacement system and upcoming Sapient 3 mitral replacement system provide a broad set of treatment options to serve the many diverse and complex patients in need.
We are pleased with the Q3 results, achieving $91 million in sales, representing 74% growth over the prior year. Sales were led by PASCAL growth globally. We continued the initial commercial expansion of EVOQUE in the US and Europe.
Globally, we continue to see more patients diagnosed and treated as long as strong therapy adoption, resulting in mitral procedures experiencing ongoing double-digit growth and even stronger tricuspid therapy growth.
Adoption of a differentiated PASCAL technology is expanding in both new and existing sites around the world. We look forward to presenting the two-year outcomes of a Class IId pivotal trial studying DMR patients at TCT next week.
We are also pleased to announce the earlier-than-expected completion of enrollment for the Class II TR trial studying TR patients with PASCAL randomized against optimal medical therapy alone. This achievement is great news for patients suffering from tricuspid regurgitation given the differentiated characteristic of PASCAL.
The EVOQUE launch continues to progress well as we successfully activated new sites in both the US and Europe, beyond our initial trial centers. We are also increasing our field teams to deliver on our high-touch model to support new sites as they bring EVOQUE into their clinical practice in order to achieve excellent patient outcome.
The strong interest in this therapy continues to highlight the large unmet need. The full 400-patient cohort of a TRISEN-2 pivotal study at one year will also be presented at TCT next week.
In our continued efforts to reach more patients, a fourth and larger size EVOQUE valve, the 56-millimeter, was recently approved in the US. The addition of this larger valve size will expand the addressable patient population. On October 1, EVOQUE became eligible for Medicare's new technology add-on payment with additional payment above standard reimbursement is in effect for three years and will support increased access to this breakthrough therapy for the many US patients in need.
Based on the ongoing global adoption of our two therapies, PASCAL and EVOQUE, we remain confident in our full year TMTT sales guidance at the high end of $320 million to $340 million.
In surgical, third quarter sales from continuing operation of $240 million increased 5% over the prior year. Growth was driven by strong global adoption of Edwards premium surgical technologies INSPIRIS, MITRIS and KONECT. We continue to see positive procedure growth globally for the many patients best treated surgically, including those undergoing complex procedures. We continue to expand the overall body of resilient evidence and enrollment in Europe for our MOMENTIS critical trials studying MITRIS is ahead of schedule.
In addition, comments AR manuscript has been published in the Journal of Thoracic and Cardiovascular Surgery, which shows positive outcome for patients with AR treated with RESILIA tissue valves after five years. Finally, two investigator-initiated registries out of Europe Enduro and IMPACT have shown a favorable outcome in younger and more complex patients who were implanted with the RESILIA INSPIRIS valve.
In summary, we continue to believe that our full year 2024 surgical sales growth will be 6% to 8%.
Turning to structural heart failure. In Q3, we closed the acquisition of Endotronix, making -- marking our entry into implantable heart failure management or IHFM. Our vision for IHFM is consistent with our other structural heart technologies: to establish a platform that ensures best-in-class outcome for patients in in need, resulting multiyears of growth.
We released a strong 12-month results from the proactive HF pivotal trial at the HFSA Conference, which demonstrated significant benefit to patients managed with the Cordella system, an implantable pulmonary artery pressure sensor, allowing early targeted heart failure intervention. In addition, the proactive HF II trial has also been initiated, which will extend the evidence base for implantable heart failure management and further demonstrate the value of data-driven heart failure management.
With the recent approval of Cordella in the US and the completion of our first cases, our focus is on building our commercial team, deploying physician training, case support to ensure high quality of outcomes. Revenue will ramp over time as we focus on disciplined commercialization, outcome, system usage and patient engagement.
And now I will turn the call over to Scott.
