Bernard J. Zovighian
Chief Executive Officer at Edwards Lifesciences
Thank you, Mark. We are pleased with our total company performance with first quarter sales growth of 10% to $1.6 billion versus the year-ago period. As a result, we are raising our 2024 sales guidance to the high end of 8% to 10%.
As we look ahead, I'd like to share some perspective about the strategic direction of our company. Edwards is well positioned to extend our leadership and deliver sustainable growth, driven by the strategic investments we have made across our transcatheter platforms to address the large and growing needs of patients impacted by aortic, mitral and tricuspid disease.
We remain confident in the many opportunities to grow TAVR over the long term. In addition, TMTT is becoming an increasingly significant contributor to Edwards' growth, and we expect this will continue. An important element in our valve innovation leadership is our advanced tissue technology. We have been an innovator in tissue technology for more than 50 years and we are pleased with our latest technology RESILIA. With differentiated evidence of advanced durability, this technology is used across our comprehensive portfolio with a focus on lifetime management of the patients we serve. We are pleased that 0.5 million of patients will benefit from this tissue technology by the end of 2024.
As the global leader in structural heart, we remain deeply committed to bringing the highest quality evidence, groundbreaking technology and world-class physician support to advance science and meaningfully improve patient care. This year, we are already making significant progress on multiple clinical trials and next-gen technologies.
In January, we achieved an important milestone with the completion of patient treatment in PROGRESS, a pivotal trial studying the treatment of moderate aortic stenosis patients, a population estimated to be twice as large severe aortic stenosis.
In February, EVOQUE became the first transcatheter therapy to receive U.S. FDA approval for the treatment of patients with tricuspid regurgitation. EVOQUE is a groundbreaking treatment options that not only have the potential to improve quality of life, but also shown favorable clinical trends in all-cause mortality, reintervention and heart failure hospitalization.
In March, at the annual CRT Conference, we announced compelling results from two large real-world studies demonstrating continued excellent outcome for patients treated with the Edwards SAPIEN valve platform. And earlier this month, at the American College of Cardiology Conference, we announced data from the HUDDLE study. Initiated by Edwards in 2021 with our partner at NFL Alumni Health, the study examine the prevalence of structural heart disease among groups historically known to experience disparities in access to care.
Edwards is committed to helping identify and dismantle barriers to access for communities that are underserved due to race, gender and socioeconomic status. Each of these reflect our deep commitment to advancing patient care through our differentiated strategy and reinforce our confidence in sustaining the growth of transcatheter based structural heart intervention.
Now, I will provide some additional detail on Q1 results by product group. In TAVR, first quarter global sales of $1 billion increased 8% year-over-year when adjusted for billing days. Q1 marked the first quarter that Edwards TAVR sales exceeded $1 billion, an exciting milestone for our team and a testament to clinicians' confidence in our leading technology. Performance was driven by growth in the U.S. and Japan, Edward's global competitive position and selling prices were both stable.
In the U.S., our year-over-year first quarter TAVR sales growth rate was higher than our global constant currency growth rate. We estimate total procedure growth was comparable. Procedure volumes increased as the quarter progressed. We remain pleased with the continued performance of our best-in-class TAVR platform, SAPIEN 3 Ultra RESILIA, which builds on Edwards long-standing leadership in tissue technology and durability. This innovative technology now makes up the majority of our sales in the U.S. This platform is supported by the robust real world data for more than 10,000 patients in the TVT Registry that demonstrated excellent outcomes across hundreds of centers.
The technology's optimized tissue treatment is designed to extend durability of a valve, a feature that will be increasingly important as the therapy continues to treat patients with longer life expectancy. We are also proud to continue our deep commitment to advancing science for AS patients through the progress and early TAVR trials.
As discussed in January, we completed enrollment and treatment of patients in progress, approximately two years of expectation. We also expect to release the results of early TAVR at the TCT Conference this year. Symptom assessment is one of the most significant barriers to referral and the early TAVR trial evaluates the impact of TAVR on asymptomatic patients with severe AS. We believe if data are compelling, early TAVR may have a meaningful impact on deciding when to treat patients, while also streamlining referral and patient care for all severe AS patients.
Outside of the U.S., in the first quarter, our constant currency TAVR sales growth was slightly below our global TAVR growth, strong growth in Japan and the rest of the world was partially offset by slower than expected growth in Europe. In Europe, our results were softer than expected in Q1, but we expect full year 2024 performance to normalize. We are actively preparing for the launch of SAPIEN 3 Ultra RESILIA in Europe, and we anticipate introducing the technology into the European market in Q2.
In Japan, we continue to see strong TAVR adoption driven by SAPIEN 3 Ultra RESILIA. We believe AS remains a significantly undertreated disease among the substantial elderly population and continue to focus on expanding the ability of an evidence supporting this therapy.
In closing, we are confident that Edwards is positioned for healthy and sustainable TAVR growth well into the future, driven by our element development of differentiated TAVR technology, our deep commitment to advancing patient care through high-quality clinical evidence, and our investment in patient activation initiatives. Importantly, we are proud of our groundbreaking research into the treatment of AS through our early TAVR and PROGRESS trial, which could fundamentally change how AS patients are treated.
We remain confident in our full year TAVR sales growth of 8% to 10%. We expect higher year-over-year second half growth rate than in the first and second quarter.
Turning to TMTT. We drove positive momentum with our unique and broad portfolio strategy for both repair and replacement therapies for mitral and tricuspid patients. We made significant progress in advancing important technologies, including the PASCAL repair system, the EVOQUE tricuspid replacement system, and the SAPIEN M3 mitral replacement system. We are the only company with multiple approved mitral and tricuspid therapies backed by world-class evidence to improve patient care.
In Q1, we achieved positive results with sales of $73 million, representing a 72% increase versus the prior year. The majority of our Q1 sales were driven by expanded adoption and new site activation of PASCAL supported by continued double-digit tier market growth in the U.S. and Europe. We are also pleased with strong physician feedback and excellent procedural outcome with the EVOQUE, tricuspid valve in both the U.S. and Europe.
With this replacement technology, we see the unique elimination of tricuspid regurgitation, significant quality of life improvement for patients and favorable trend in all-cause mortality and heart failure hospitalization. The increasing physician demand for EVOQUE is a clear indication of unmet need and the potential for this therapy to treat a very large patient population. We continue to invest in expanding our high-touch field organization globally to support this therapy in order to continue to achieve excellent outcome for each patient.
Given the strong adoption of our differentiated technology, PASCAL and EVOQUE, we are raising full year TMTT guidance to $320 million to $340 million versus previous guidance, which was the higher end of $280 million to $320 million range. We are confident that our unique portfolio strategy with repair and replacement options for both mitral and tricuspid will offer clinicians the broad set of therapies necessarily to effectively treat many patients in need. This strategy positions us for global leadership, sustainable long-term growth and an increasing contribution to overall Edwards growth.
In Surgical, first quarter sales of $266 million increased 8% 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 for both undergoing complex procedures.
We continue to expand the overall body of evidence in multiple technologies and multiple valves and now expect U.S. and Canada enrollment of our MOMENTIS clinical studying RESILIA performance in the mitral position to be completed in Q2 2024, one year ahead of expectation. The study will continue to open new sites in Europe and Latin America with global enrollment continuing into 2025. We are now raising our full year Surgical sales guidance to 6% to 8% and versus expectation of mid-single digit growth.
In Critical Care, variability of demand led to better-than-expected first quarter sales of $251 million, which increased 14% versus the prior year, driven by contribution from all product lines. Growth was led by our smart recovery technologies, including the Acumen IQ sensor. Demand was also strong for our Swan-Ganz catheters and pressure monitoring devices used in the ICU.
Critical Care remains focused on driving growth through smart recovery and smart expansion, which are designed to help clinicians make more informed decisions and get patients home to their family faster.
We are now confident in raising our full year critical sales guidance to 8% to 10% versus previous expectation of mid-single digit growth. Since announcing the spin-off of Critical Care in December, our team has made significant progress, and I want to thank all of them for their hard work and dedication. Scott will provide additional details.
And now, I will turn the call over to Scott.
