Michael F. Mahoney
Chairman and Chief Executive Officer at Boston Scientific
Thanks, Lauren, and thank you everyone for joining us today. I'm very proud of the agility and winning spirit of our employees and continue to be impressed with the resiliency of hospital systems and their ability to provide patients with the care they need during the pandemic. We're very pleased with the strength of our fourth quarter performance and anticipate that all of our business units either maintained or gained share in the quarter despite the challenges COVID presented.
On a full year basis, the global strength of our product diversification and category leadership strategy resulted in all businesses, with the exception of CRM in US EP gaining share. We look forward to the year ahead and remain bullish in both the near-term and the longer-term opportunities we laid out at our Investor Day.
In fourth quarter '21, total company operational sales grew 17% versus 2020, while organic sales grew 15%, achieving the high-end of our guidance range of 12% to 16%. Fourth quarter '21 organic sales grew 7% versus '19. Full year 2021 operational sales grew 19% versus 2020, while organic sales grew 19%, again achieving the high-end of our guidance range of 18% to 19%. Full year '21 organic sales grew 6% versus 2019. Q4 adjusted EPS of $0.45 grew 94% versus 2020 and was flat to 2019, achieving the high-end of the guidance range of $0.43 to $0.45. Full year adjusted EPS of $1.63 grew 69% versus 2020% and 3% versus 2019, again exceeding the high-end of the full year guidance range of $1.60 to $1.62.
Fourth quarter adjusted operating margin was 26.2%, resulting in the second half 2021 run rate of 25.9%. The full year '21 adjusted operating margin was 25.3%. Overall, we're very pleased with the cash flow with full year 2021 free cash flow generation of $1.3 billion and adjusted free cash flow of $2.2 billion, which grew 11% versus 2020.
So turning to 2022, while we anticipate less of a COVID impact on underlying procedures for the full year 2022 versus 2021, we're providing a wider range to account for uncertainty related to COVID waves and staffing shortages. For first quarter '22, organic revenue were guidance growth of 5% to 8% and for full year of 6% to 8%, excluding the Baylis acquisition, which is expected to close in first quarter of 2022.
Our Q1 adjusted EPS estimate is $0.38 to $0.40, and we expect our full year adjusted EPS to be $1.73 to $1.79. Despite the near-term macroeconomic pressures in 2022, we continue to target operating margin expansion with a goal of double-digit adjusted EPS growth at the high-end of the range. Dan will provide more details on both sales and EPS performance and outlook, including more insights on 2022.
I'll now provide more highlights in Q4 and full year '21 results along with comments on '22 outlook. Regionally, on an operational basis, the U.S. grew 20% versus fourth quarter 2020 and full year 21% -- full year 2021 grew 25% inclusive of a 300 basis point tailwind from acquisitions and continued strength of new product launches across the portfolio. Europe, Middle East, Africa grew 16% on an operational basis versus both fourth quarter '20 and full year '20.
We continue to see strong performance in Europe despite the pandemic impact with many of the Western countries, and excellent growth in the Middle East and Africa region. On a full year basis, all business units in Europe grew double digits versus the prior year, with the majority of businesses gaining share. We continue to anticipate strong growth from our Europe region given the innovative product pipeline, globalization efforts and the integration of the acquisitions.
Asia-Pac grew 17% operationally versus fourth quarter '20, and 14% for the full year. Within the quarter, the vast majority of Asia-Pac countries grew versus prior year with double-digit growth in IC, PI and EP, supported by new and ongoing product launches. On a full year, Japan grew 7%, fueled by new products like WATCHMAN FLX, POLARx and Ranger, as well as innovative launches across the coronary therapies portfolio.
I'll now provide some additional comments on our business units. Urology and Pelvic Health sales grew 9% on an organic basis versus fourth quarter '20, and on a full year basis grew 19% versus 2020 and 11% versus 2019. Within the quarter, SpaceOAR and Rezum both grew double digits and we're pleased with the '22 improved reimbursement for the ASC and hospital outpatient setting for Rezum. On a full year basis, we saw strength across the business with double-digit growth on LithoVue, Core Stone, Rezum, SpaceOAR and erectile restoration. As we look forward towards 2022, we remain excited about our strategy -- our strong leadership position further extended by the acquisition of Lumenis in the market-leading Moses laser technology.
Turning to endoscopy, sales grew 10% organically versus fourth quarter '20, with full year growth of 19% versus '20 and 12% versus 2019. Over the duration of the year, broad-based strength across all regions and franchises resulted endoscopy business achieving $2 billion in 2021. Within the quarter, we launched the AXIOS stent in China, and on a full year basis grew this product line over 20% globally. We remain excited about the outlook of our innovative offerings within our single-use imaging portfolio, including Spyglass DS, EXALT Model D, EXALT Model B, and Spy Discover. Looking at 2022, we continue to anticipate above market growth as the endoscopy global commercial teams continue to execute at a high level by creating long-term partnerships with hospitals given the unique breadth and differentiation of our portfolio.
Turning to CRM, organic sales grew 4% versus fourth quarter 2020, and full year sales grew 8% versus '20, and declined 6% versus '19. In Q4, our high-voltage business grew low single digits, which we expect was in line with the market with improved sequential growth in our S-ICD franchise, enabled by our enhanced electrode launch in June. The pace of business grew mid-single digits, which was likely in line with the market. In December, we enrolled our first patients in the modular ATP trial, our dual track clinical study for a standalone leadless pacemaker, as well as to provide anti-tachycardia pacing to EMBLEM S-ICD patients.
Within the diagnostics franchise, our implantable cardiac monitor Lux-Dx continues to perform well and grow share. The Preventice business grew 20% on a full year pro forma basis, enabled by our differentiated portfolio and strong execution. Electrophysiology sales grew 16% versus fourth quarter '20 on an organic basis with full year growth of 23% versus '20 and 7% versus '19. Importantly, the international EP sales grew 38% versus prior on a full year operational basis, fueled by our innovative portfolio, including POLARx, Stablepoint and Farapulse. The early Farapulse launch is going well in Europe with physicians enthusiastic about the safety and ease of use of this technology. We're very excited about the outlook of the EP business and look forward to further complement it with the closing the Baylis in first quarter '22.
In neuromodulation, fourth quarter organic revenue grew 6% versus prior year and full year sales grew 19% versus 2020, and were flat to 2019. Despite the COVID wave impacting procedure volumes, we continue to gain share with strong demand for our WaveWriter Alpha Systems and ongoing clinical evidence, resulting in a full year SCS growth rate of over 20% versus 2020.
Just a few weeks ago we presented various datasets of NANDs including the two-year combo RCT data supporting the longevity -- longevity of our SCS therapy. We continue to enroll in the SOLIS trial, studying our WaveWriter SCS Systems for the treatment of patients with the chronic low back and/or leg pain, who have not undergone spinal surgery and anticipate initial clinical work on DPN in the coming months.
In our brain franchise, while COVID impacted of procedure volumes, we continue to enhance our portfolio and capabilities with strong full year growth in '21 versus 2020. We look forward to expanding our U.S. Vercise Genus offering in '22 in partnership with Brainlab.
In interventional cardiology, organic sales grew 40% versus fourth quarter 2020, and 31% versus full year '20, which includes a tailwind of approximately 1,000 basis points related to sales return reserves for the transition to consignment for WATCHMAN in 2020. Full year interventional cardiology sales grew 7% versus 2019.
In coronary therapies, our complex PCI franchise had strong growth in '21, with strength across every region, further enabled by the recent launch of our AVVIGO II Guidance System in the U.S. Within drug-eluting stents, we continue to differentiate our portfolio to the global launches of SYNERGY 48-millimeter and MEGATRON. We continue to anticipate being the first to U.S. market in 2024 with our Agent drug-coated balloon and expect to complete enrollment in the U.S. IDE trial in the first half of 2022.
We're extremely pleased with the performance of WATCHMAN franchise in the fourth quarter as sales surpassed our expectations. Importantly, the 2021 global performance of WATCHMAN was consistent each quarter with strong double-digit growth, resulting in a full year sales of $830 million, growing 68% [Phonetic] versus 2019. We continue to be pleased with our ability to deliver the safest and most efficient therapy, increase physician utilization and global expansion, while driving greater awareness to this fast-growing LAAC market.
Clinical evidence generation remains an important focus and we expect the first readout from the ongoing surpass analysis of the NCDR LA Registry at CRT later this month. This analysis will include over 16,000 patients and is the largest dataset in WATCHMAN FLX patients presented to date. We continue to expect WATCHMAN to be a significant growth driver for Boston Scientific in '22 and beyond.
Across the structural heart franchises, we had the highest quarterly sales results to date for ACURATE Neo2, SENTINEL and the SAFAR Guidewire. ACURATE Neo2 continues to perform well with positive physician feedback on the clinical performance and ease of use of the valve and we're excited for the year with over 10% share across full European market, and are approaching 20% share in open accounts. While we've been pleased with the early clinical progress of the Millipede [Phonetic] technology, we have decided to discontinue work in the Millipede program due to the time and financial investment required to commercialize this platform as compared to other near and long-term portfolio opportunities across the company. We've made this decision now so that we can focus on execution of the existing and future technologies within the structural heart space and elsewhere within our portfolio.
In peripheral interventions, organic sales grew 9% versus fourth quarter 2020 with full year sales growth of 14% versus '20 and 9% versus 2019. Within the drug-eluting portfolio, we've been pleased with the globalization and ongoing clinical evidence supporting Eluvia and Ranger, resulting in exceeding our sales goal of $150 million for 2021. In venous, our market in varicose vein offering Varithena grew over 40% in 2021, and we see continued runway with this underserved market.
In Q4, we closed the Devoro acquisition and look forward to launching our arterial and venous offerings in the second half of 2022, complementing the broader portfolio and further extending our category leadership. In interventional cardiology, TheraSphere grew over 20% on a full year basis, supported by ongoing clinical evidence, including the Epoch trial, which is the first positive Phase III SIRT trial studying TheraSphere as a second-line therapy in patients with liver dominant mCRC that have failed first-line chemotherapy.
Our focus on improving patient health comes with the responsibility to have a positive impact in a world we share. Our environmental, social and governance practices guide us as we make long-term measurable progress, and I'm proud to announce that Boston Scientific received the 2022 Catalyst Award, the premier recognition for organizations initiatives to advance women in the workplace. Boston Scientific also ranked in the top 50 of America's Most Just Companies for our contributions to creating jobs, providing benefits and work life balance, cultivating a diverse and inclusive workplace and producing sustainable products and building stronger communities.
I'm grateful for the passion and commitment of our global team as we continue to live our values and do our part to create a better future, both as a global business and as a global corporate citizen. While we have faced challenges over the last few years of COVID, we are stronger for it, we're building new capabilities that will enable us to better serve our patients and customers both today, in the future.
We are well positioned in 2022 with category-leading innovative product positions, continue to focus in investment in clinical evidence, while continue to enter high growth adjacent markets. We acquired several companies in the past year with innovative products that are accretive markets and we continue to evolve our leadership and commercial structures to best enable these exciting new technologies. We remain committed to our long-term financial goals of 6% to 8% organic revenue growth, operating margin expansion, double digit adjusted EPS growth with strong cash flow generation. I'm very grateful to our employees for their winning spirit.
I will now turn things over to Dan to review our financial performance and forward-looking expectations.