Michael Mussallem
Chairman and Chief Executive Officer at Edwards Lifesciences
Thank you, Mark.
During 2022, our company stayed focused on the long-term, making meaningful progress on strategic milestones with the potential of transforming patient care. While the challenging environment negatively impacted sales, we still grew 8%. Looking forward, we remain optimistic that the healthcare environment will gradually improve, and we expect 9% to 12% sales growth in 2023.
We didn't pull back on investing in innovation because of the pandemic, and we didn't pull back because sales fell a little short, we continue to aggressively invest during this challenging period which positions the company for sustained leadership in a new era of structural heart and critical care innovation.
Looking back at 2022, in TAVR, we made important strides in executing our long-term strategy. We received approval and launched the innovative SAPIEN 3 Ultra RESILIA valve. In TMTT, each of our platforms demonstrated promising clinical performance and we received approval for PASCAL PRECISION in the US and Europe.
In Surgical Structural Heart, we extended our leadership position through the launch of MITRIS in the US. And in Critical Care, we continue to drive adoption of our transformative smart recovery technologies. Although our initial sales expectations for 2022 anticipated a better environment, we delivered balanced contributions across each of our product groups and regions. We achieved 12% growth in adjusted earnings per share, while maintaining R&D at more than 17% of sales, which reflects our commitment to driving durable organic sales growth.
Consistent with our cash deployment strategy, we opportunistically repurchased stock at an accelerated level in 2022. We continue to invest in our production capacity in anticipation of future growth and we made a series of external investments in promising early-stage technologies.
Turning to our fourth quarter financial results, consistent with our guidance, total company sales grew 7% on a constant-currency basis to $1.3 billion. Our broad portfolio of innovative therapies drove this growth despite the healthcare disruptions in a number of our key geographies.
In TAVR, full-year 2022 global TAVR sales of $3.5 billion increased 7% on a constant-currency basis, building nearly 20% growth in the year-ago period. Sales were below our original guidance of $3.7 billion to $4.0 billion due to foreign-exchange headwinds and COVID-induced health challenges in key countries.
In 2022, we announced the approval of SAPIEN 3 Ultra RESILIA in the US. Separately, we continued to advance enrollment in our progress pivotal trial for moderate AS patients, and gained significant learnings from our ALLIANCE pivotal trial to study the next-generation TAVR technology: SAPIEN X4. These transformative developments reinforce our long-term confidence in the strong growth of our transcatheter-based aortic valve interventions.
In the fourth quarter, our global TAVR procedures were comparable with Edwards growth. Our global, I should say, global TAVR procedures were comparable with Edwards growth. Our global TAVR sales of $868 million increased 5% year-over-year on a constant-currency basis, consistent with our expectations.
Sales were up slightly over Q3 in dollars and on a constant-currency basis, and local selling prices were stable. In the US, Edwards fourth-quarter TAVR procedures grew in the mid-single-digit range. As expected, our fourth-quarter US TAVR procedure volumes were impacted by the US hospital staffing constraints and the holiday season slowdown. We estimate that our share of procedures was stable. Both in the US was higher in larger volume centers and in states with fewer COVID restrictions as measured by the [Technical Issues] Containment and Health Index.
We are encouraged by recent hiring trends which suggest that hospital employment is rebounding. As we mentioned, we began the introduction of SAPIEN 3 Ultra RESILIA in the US. The RESILIA tissue's anti-calcification technology addresses one of the primary causes of reintervention following heart valve replacement and is demonstrating a strong track record of performance in Edwards surgical valves. As of now, this newest valve has been introduced in approximately 10% of US TAVR centers, and physician feedback has been encouraging.
Outside of the US, in the fourth quarter, Edwards TAVR procedures also grew in the mid-single-digit, and we estimate total procedure growth was comparable. In Q4, geographies outside of Europe and Japan grew even faster in the quarter. Long-term, we see excellent opportunities for growth as we believe international adoption of TAVR remains quite low.
In Europe, fourth-quarter procedures grew in line with the global rate. Market growth continued to be impacted by a bump in the COVID cases and staffing shortages, which reduced hospital capacity, particularly in larger countries such as Germany. And even though there are a broad range of competitors, our leadership position and local selling prices remained stable throughout the year.
Importantly, a cost-effectiveness study published earlier this month demonstrated that TAVR with SAPIEN 3 was economically beneficial when compared to surgical aortic valve replacement in treating German patients with low surgical risk. The data suggests that TAVR enhances quality of life and offers a cost-effective option over the long term. These findings are consistent with the cost-effective outcomes for the use of SAPIEN 3 in France, Italy and Spain.
In Japan, fourth-quarter procedure growth was much slower than expected due to an extended COVID wave and continued restrictions, which limited hospital staffing and capacity. We expect these factors to diminish substantially over the course of 2023, and look forward to launching SAPIEN 3 Ultra RESILIA in Japan, later this year.
We remain focused on expanding the availability of TAVR therapy driven by the fact that AS remains a significantly undertreated disease amongst this large elderly population. In summary, our outlook assumes COVID-related challenges improve during 2023 as hospital resource constraints decrease. We remain positive in our outlook for 2023 underlying TAVR sales growth of 9% to 12%, consistent with the range we shared at our December Investor conference.
We remain confident in this large global opportunity that will double to $10 billion by 2028, which implies a compounded annual growth rate in the low-double-digit range.
Turning to TMTT. Since launch, we have proudly treated more than 10,000 patients with the PASCAL repair system. We achieved significant milestones in 2022 and made meaningful progress toward achieving our vision to transform care for patients with mitral and tricuspid disease. Following the Class IID presentation at TCT and FDA approval in Q3, we initiated the introduction of the PASCAL PRECISION system in the US. Initial feedback from clinicians has been positive and we're pleased with the patient outcomes to date. Class IID full cohort of 300 patients with one-year follow-up will be presented in the second half of 2023.
In Europe, the PASCAL PRECISION launch is ongoing with a focus on bringing this latest advancement to our existing centers as well as expanding into new centers. Also, aligned with our commitment to generate high-quality scientific evidence, we continue to advance enrollment in our Class IIF pivotal trial for patients with functional mitral regurgitation.
In mitral replacement, we're making good progress on the enrollment of the ENCIRCLE pivotal trial for SAPIEN M3, and expect to complete enrollment of the main cohort around the end of 2023. This sub-French transfemoral valve leverages the SAPIEN 3 platform with a recapturable, repositionable dock.
Separately, we have completed enrollment in the MISCEND early feasibility study with the Eos valve and are incorporating the learnings from this early experience into our next iteration. We believe the Eos platform has the potential to be an excellent option for mitral patients who have a poor prognosis and limited treatment options.
Shifting to tricuspid and our strategy of advancing the body of clinical evidence, we are currently enrolling two pivotal trials, studying both tricuspid replacement and repair: TRISCEND II and the Class IITR. We -- prioritized enrollment in TRISCEND II study trial that's studying EVOQUE as it addresses the large population of patients who are suffering from debilitating symptoms and have few treatment options.
TRISCEND II is on track for completion of enrollment in the first half of 2023, and we expect EVOQUE CE Mark by the end of this year, and US approval around the end of '24. We're very pleased with the recent tricuspid data presented at PCR London Valves meeting which were -- which we reported favorable results from both our TRISCEND study of EVOQUE and the TriCLASP post-market clinical follow-up for PASCAL.
In Europe, clinicians are very positive about the performance of our differentiated PASCAL PRECISION system in their tricuspid patients and we're looking forward to bringing this therapy to patients in the US following the Class IITR trial.
Turning to the sales performance of TMTT, fourth-quarter sales of $32 million, were consistent with our latest guidance and driven by the continued adoption of PASCAL in Europe, supported by the early initiation of PASCAL PRECISION in the US.
Full-year global sales were $116 million, up nearly 50% on a constant-currency basis versus the prior year. In 2023, we expect TMTT, sales of $160 million to $200 million. We look forward to advancing our vision to transform the lives of patients with mitral and tricuspid valve disease through the milestones outlined at our recent investor conference. We remain committed to bringing this differentiated portfolio of therapies to patients with these life-threatening diseases and believe our strategy positions us well for leadership.
In Surgical Structural Heart, full-year global sales were $893 million, up 6% on a constant-currency basis versus the prior year. Fourth-quarter 2022 global sales of $224 million increased 8% on a constant-currency basis over the prior year. We were encouraged to see strong global growth driven by the increased penetration of our premium resilient products despite COVID challenges in certain regions.
Although hospital staffing shortages continue to be a concern, we believe that heart valve surgery was prioritized. We have seen strong momentum of the RESILIA portfolio globally. We believe that surgeons value the features and benefits of this advanced tissue technology for both aortic and mitral surgical valve replacement procedures. We saw adoption of the MITRIS RESILIA valve in the US increase in the fourth quarter. And built upon previous generations of proven mitral valve technology, MITRIS offers greater ease of use and is designed to facilitate potential future transcatheter interventions.
We are growing the large body of RESILIA evidence with our new Momentous clinical study to demonstrate the durability of this tissue in the mitral position. Enrollment in this study was initiated earlier this month.
In summary, we remain confident that our full-year 2023 underlying sales growth will be in the mid single-digits for Surgical Structural Heart, driven by the adoption of our most advanced technologies and growth of overall heart valve surgeries.
Turning to Critical Care. Full-year global sales of $855 million increased 7% on a constant-currency basis versus the prior year. Fourth-quarter Critical Care sales of $225 million increased 13% on a constant-currency basis over the prior year. Growth was driven by contributions from all product lines and regions led by HemoSphere and Smart Recovery.
In our Smart Recovery portfolio, adoption of our FloTrac and ClearSight sensors, featuring our unique hypotension prediction index algorithm remains strong. Demand for our pressure monitoring devices used in the ICU also increased in Q4 due to elevated hospitalizations in the US.
As discussed at our recent investor conference, the integration of a full range of technologies creates a unique offering of enhanced recovery tools and predictive analytics to further strengthen our leadership in hemodynamic monitoring.
In summary, we're encouraged by the strong momentum in critical care and continue to expect mid-single-digit underlying sales growth in 2023. We remain enthusiastic about our pipeline of Critical Care Innovations, highlighted by Smart Recovery technologies, designed to help clinicians make better decisions and get patients home to their families, faster.
And now, I will turn the call over to Scott.
