Chairman & Chief Executive Officer at Edwards Lifesciences
Thanks, Mark. The third quarter strengthened our conviction in our company's patient-focused innovation strategy. Globally, structural heart procedures grew less than we expected in the third quarter but that didn't slow us down, as our team accomplished numerous important milestones and made good progress on our multiple clinical trials and next-generation technologies. In August, we received European regulatory approval for PASCAL PRECISION. This unique system is designed for transcatheter-based edge-to-edge leaflet repair in patients suffering from mitral and tricuspid regurgitation.
Shortly thereafter, in September, we received early U.S. FDA approval for PASCAL PRECISION for the treatment of patients with degenerative mitral regurgitation which was welcome news for clinicians who appreciate this differentiated platform. And in TAVR, last month, we announced approval to begin selling the SAPIEN 3 Ultra RESILIA valve in the U.S. our industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve now incorporates Edwards' breakthrough RESILIA technology. Additionally, during the third quarter, enrollment accelerated in our 2 TAVR pivotal trials, progress evaluating patients with moderate AS and Alliance for our next-generation TAVR technology, SAPIEN X4. These transformative developments reinforce our confidence in the continued growth of transcatheter-based structural heart inventive. We will continue to aggressively pursue breakthrough technologies with the potential to help even a broader group of patients and in turn drive significant future value.
Now, turning to our financial performance. Third quarter total company sales of $1.3 billion increased 7% on a constant currency basis versus the year ago period. Our broad portfolio of innovative technologies drove this growth, although it was at the lower end of our expectations, reflecting persistent U.S. hospital staffing shortages and COVID headwinds in Japan. Adjusted EPS grew 13% even while aggressively investing in R&D and commercial infrastructure to support new therapies. For full year 2022, we expect total Edwards sales will be negatively impacted by foreign exchange and be at the low end of our previous range of $5.35 billion to $5.55 billion. We anticipate hospital staffing challenges and a predictive difficult winter COVID and flu season will continue into next year. In TAVR, third quarter global sales of $862 million increased 6% on a constant currency basis. Sales were below our expectations due primarily to the persistent U.S. hospital staffing shortages and COVID headwinds in Japan which intensified the typical impact of summer seasonality.
In the third quarter, we're pleased that well over 30,000 patients were treated with SAPIEN across our more than 2,000 global TAVR centers. We estimate that global TAVR procedure growth was comparable with Edwards' growth in the third quarter. Local selling prices were stable, although the average global selling price declined due to the weakening euro and yen. In the U.S., our TAVR procedures increased in the mid-single digits versus the prior year. We estimate that our share of procedures was stable. As expected, our third quarter U.S. TAVR procedure volumes continued to be impacted by regional U.S. staffing constraints which were somewhat worse than we anticipated. There were a high level of variability in growth rates across centers around the country. And while staffing issues limited overall growth during the quarter, nearly half of our TAVR centers grew double digit in Q3. Outside the U.S., in the third quarter, our TAVR sales grew in the low double digits on a constant currency basis and we estimate total procedure growth was comparable.
Our underlying 3-year compounded annual growth rate outside the U.S. remains in the mid-teens. In Q3, geographies outside of Europe and Japan grew even faster in the quarter. Long term, we see excellent opportunities for OUS growth as we believe international adoption of TAVR remains quite low. In Europe, sales were down sequentially as expected, even though we compete with a broad range of competitors, our competitive position remains stable. Scattered staffing shortages slightly exacerbated summer seasonality and we anticipate some lingering regional impact on that.
In Japan, third quarter procedure growth was impacted by a widespread seventh wave of COVID which created a significant strain on hospital capacity and limited TAVR procedure volumes. As you might expect, procedure volumes in Q3 varied across the country as patients and the providers were incentivized to turn their focus again to the treatment of patients with COVID. We saw TAVR procedure volumes improve as COVID hospitalizations decreased late in the third quarter. 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, we anticipate the continuation of staffing shortages and a difficult winter, COVID and flu season. We expect Q4 TAVR sales to be around $850 million and full year 2022 TAVR sales to be at the low end of our previous range of $3.5 billion to $3.7 billion. We remain confident about the long-term potential of TAVR as the rapidly evolving evidence recognized by policymakers around the world supports continued adoption of this therapy for the many patients suffering from aortic stenosis. This broad-based, favorable evidence, combined with the undertreatment rate and growing elderly population supports our expectation that this global TAVR opportunity will reach $10 billion by 2028 which implies a low double-digit compounded annual growth rate.
Turning now to our transcatheter mitral and tricuspid therapies product group. Recently, we received U.S. FDA and European CE Mark approval of PASCAL PRECISION. This next-generation system designed to facilitate precise navigation and an intuitive user experience will enable us to initiate our commercial presence in the U.S. for the treatment of patients suffering from degenerative mitral regurgitation and also expand PASCAL adoption in Europe for both mitral and tricuspid patients. This exciting news was followed by the presentation of first results from the Class IID pivotal trial at the recent TCT conference. This first-of-a-kind head-to-head randomized pivotal trial further established the safety and efficacy of mitral transcatheter edge-to-edge repair. We were pleased that this data demonstrated that PASCAL is a beneficial therapy expanding transcatheter treatment options for DMR patients. In addition, we continue to advance enrollment of our Class IIF pivotal trial for patients with functional mitral regurgitation.
Separately, we continue to treat patients with our 2 transcatheter mitral replacement therapies through the ENCIRCLE pivotal trial for SAPIEN M3 and the MISCEND study for EVOQUE Eos. We are pleased with our progress and believe these sub-30 French transfemoral therapies will help transform treatment for patients and expand the mitral opportunity.
Turning to tricuspid. We continue to make progress enrolling the TRISCEND II pivotal trial of the EVOQUE replacement system and the Class IIR pivotal trial with the PASCAL repair system in patients with symptomatic severe tricuspid regurgitation. We no longer anticipate CE Mark approval for EVOQUE tricuspid replacement in Europe this year. As uncertainties remain around the MDR process, we now expect a CE Mark approval late in 2023, with sales contribution in 2024 when we expect to have reimbursement in place. We're excited about this therapy for the many tricuspid patients who have few treatment options today.
Looking ahead to PCR London Valves conference in November, we expect numerous late-breaking data presentations across the TMTT portfolio. Especially noteworthy is new 1-year follow-up data on our early experience with the EVOQUE tricuspid valve. We expect these presentations to contribute positively to the growing body of compelling clinical evidence for our comprehensive portfolio of transcatheter mitral and tricuspid therapies.
Turning to the sales performance of TMTT. Third quarter sales of $30 million grew sequentially from the second quarter despite summer seasonality. Adoption of the PASCAL system in Europe increased as we initiated a limited introduction of PASCAL PRECISION and we continue to have excellent outcomes for patients as we progress on a gradual expansion into more centers in Europe. We forecast to increase the number of procedures in Q4, yet expect reported Q4 sales to be similar to Q3 as a result of FX headwinds and a spike in COVID in Germany, our largest region in Europe.
We're pleased with our continued progress to our bring portfolio of therapies combined with contemporary clinical data in order to achieve our vision of transforming the lives of patients with mitral and tricuspid valve disease.
In Surgical Structural Heart, third quarter global sales of $220 million increased 8% on a constant currency basis over the prior year. We are encouraged to see strong global growth driven by increased penetration of our premium RESILIA products despite staffing challenges in certain regions. And although staffing shortages continue to be a concern, we're observing that cardiac surgeries are being prioritized. We continue to see strong momentum of the RESILIA portfolio globally as we bolster the overall body of evidence, including 4 abstracts recently presented at the European Association for Cardiothoracic Surgery Annual Meeting in Milan. We continue to believe that physicians value the features and benefits of this advanced tissue technology for both aortic and mitral surgical valve replacement procedures. Adoption of the MITRIS valve launched in the U.S. in April now represents the majority of our mitral valve sales in this region.
Separately, we've decided to exit our HARPOON surgical mitral repair system and stop enrollment in the related clinical trials. Given our experience to date, we made the difficult decision to focus on developing other innovative therapies to better serve patients and continue to be the partner of choice for cardiac surgeons. In summary, we remain confident that our full year 2022 underlying sales growth will be in the mid-single-digit range for Surgical Structural Heart driven by market adoption of our newest premium technologies and surgical market growth.
In Critical Care, third quarter sales of $207 million increased 3% on a constant currency basis over the prior year. The growth rate was impacted by a very strong prior year comparison. Sales growth was driven by increased adoption of our broad portfolio of smart recovery products, including FloTrac and ClearSight sensors with our unique hypotension prediction index algorithm. Additionally, demand for our HemoSphere monitoring platform remains strong.
In summary, we continue to expect mid-single-digit underlying sales growth for the full year 2022. We remain enthusiastic about our pipeline of Critical Care innovations, highlighted by smart recovery technologies designed to help clinicians make even more informed decisions for patients.
And now I'll turn the call over to Scott.