Vaginal intraepithelial neoplasia

March 13, 2024 3:00 am ET Company reaffirms commitment to reduce the global burden of HPV-related diseases, including certain cancers RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today, at the EUROGIN 2024 HPV Congress, announced plans to initiate clinical development of a new investigational multi-valent HPV vaccine designed to provide broader protection against multiple HPV types. Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL ® 9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen. “Evidence continues to emerge showing the importance of GARDASIL and GARDASIL 9 to public health,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These significant investments build upon our leadership and importantly provide the opportunity to further impact the global burden of certain HPV-related cancers and disease.” In the U.S., GARDASIL 9 is indicated for use in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. GARDASIL 9 is also indicated for use in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory trial is ongoing. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Multivalent HPV vaccine research Merck vaccine researchers continue to build on the development of GARDASIL and GARDASIL 9 to identify new candidates with the potential to extend protection against a broader array of HPV types. The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage. This includes several types known to have more impact in African and Asian populations and individuals of African and Asian descent. First-in-human studies (Phase 1) are scheduled to start in the fourth quarter of 2024. Assessing the potential efficacy and durability of a single dose regimen of GARDASIL 9 In response to calls from scientific leaders for more clinical data concerning alternative dosing regimens for GARDASIL 9, Merck, pending regulatory input, plans to conduct two prospective clinical trials, one in females (16-26 years old) and one in males (ages 16-26 years old). These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of GARDASIL 9 versus the currently approved three-dose regimen. The goal of these large, randomized trials is to generate data that clearly determines whether or not a single dose of GARDASIL 9 provides comparable long-term protection to the approved three-dose regimen, while also satisfying the high standards required by regulatory authorities. The clinical trials are anticipated to start enrolling participants in the fourth quarter of 2024. HPV vaccine supply To address the increasing global demand for GARDASIL and GARDASIL 9 and support broader and equitable access, Merck has made significant investments in manufacturing to help increase supply. Starting in 2019, the company committed to expand manufacturing capacity by increasing production at existing plants as well as constructing new facilities. Between 2017 and 2020 this resulted in a near doubling of supply which has subsequently been doubled again between 2020 and 2024. Merck expects to supply sufficient quantities of HPV vaccines to meet anticipated demand for 2025 and will continue to expand our supply capacity in the future. Indication for GARDASIL and GARDASIL 9 GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age. GARDASIL is a vaccine indicated in females 9 through 26 years of age. GARDASIL 9 is indicated for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11. GARDASIL 9 is indicated in males 9 through 45 years of age. GARDASIL is indicated in males 9 through 26 years of age. GARDASIL 9 is indicated for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is indicated for the prevention of anal cancer caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11. The GARDASIL 9 oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Indication - Limitations of Use GARDASIL 9 and GARDASIL do not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. GARDASIL 9 and GARDASIL have not been demonstrated to provide protection against diseases caused by: HPV types not covered by the vaccine HPV types to which a person has previously been exposed through sexual activity Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 and GARDASIL protect only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types contained in the vaccines. GARDASIL 9 and GARDASIL are not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN). Vaccination with GARDASIL 9 or GARDASIL may not result in protection in all vaccine recipients. Select Safety Information GARDASIL 9 and GARDASIL are contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL. Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL 9 and GARDASIL have not been established in pregnant women. For GARDASIL 9, the most common (≥10%) local and systemic adverse reactions in females were: injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema. For GARDASIL, the most common (≥1.0%) adverse reactions were headache, fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising. The duration of immunity for a 2-dose regimen of GARDASIL 9 is unknown. Dosage and Administration Administer either GARDASIL 9 or GARDASIL intramuscularly in the deltoid or anterolateral area of the thigh. For GARDASIL 9, a complete vaccination regimen consists of: For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months. For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months. For GARDASIL, complete vaccination regimen for individuals aged 9 through 26 years of age consists of 3 doses at the following schedule: 0, 2 months, 6 months. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf and Patient Information/Medication Guide for GARDASIL 9 at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf Media Contacts: Bob Josephson (203) 914-2372 Muchena Zigomo (+41) 79 7650365 Investor Contacts: Peter Dannenbaum (732) 594-1579 Damini Chokshi (732) 594-1577 Source: Merck & Co., Inc.

Data showed no cases of certain HPV-related high-grade disease, certain studied cancers or genital warts through 10 years for boys and girls vaccinated at ages 9-15 years RAHWAY, N.J.--(BUSINESS WIRE)-- Merck & Co. (NYSE: MRK), known as MSD outside of the United States and Canada, announced new, 10-year long-term follow-up (LTFU) data published in the peer reviewed journal, Pediatrics, for girls and boys who received a three-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at 9-15 years old. The LTFU study was conducted from 2009 through 2021 across 13 countries and five continents. “These data highlight the importance of GARDASIL 9 in prevention of certain HPV-related cancers and diseases later in life,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “HPV-related cancers and diseases are a significant public health issue. These strong study results serve as a reminder that we need to do everything we can to expand and recover vaccination rates globally to help protect all eligible people from certain HPV-related cancers.” In the U.S., GARDASIL 9 is indicated for use in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. GARDASIL 9 is also indicated for use in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory trial is ongoing. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. GARDASIL 9 targets HPV types that cause approximately 80% of cervical cancers. Additionally, HPV is responsible for causing genital warts and certain types of vulvar, vaginal, and anal cancers. For most people, HPV clears on its own, but for those who don’t clear the virus it could lead to certain cancers and other diseases. As part of the primary objective of immunogenicity, data showed sustained HPV-antibody responses at 10 years after the third dose in boys and girls. Across GARDASIL 9-targeted HPV types, antibody assessments evaluated through geometric mean titers peaked at Month 7 and decreased thereafter through 126 months. The vast majority of study participants remained seropositive at the end of the study period; 99.6% to 100% of study participants were seropositive for the targeted HPV types at Month 7 based on HPV-9 competitive Luminex® immunoassay (cLIA), and 81.3% to 97.7% remained seropositive at Month 126 depending on the HPV type. Based on the HPV-9 immunoglobulin G Luminex immunoassay (IgG-LIA), 94.9% to 100% of participants were seropositive at Month 126. In accordance with the study’s secondary objective, incidence of persistent infection and disease related to vaccine-targeted HPV types was assessed in the per-protocol population in both female and male participants. Female participants were followed up to 11.0 years post the third dose (median 10.0 years), and male participants were followed up to 10.6 years post the third dose (median 9.9 years). Among girls, there were no cases of vaccine-targeted HPV type high-grade disease – cervical intraepithelial neoplasia (CIN) 2/3, adenocarcinoma in-situ (AIS), vulval intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN) – certain cancers (cervical, vulvar, vaginal), or external genital warts observed; One case of CIN1 tested positive for HPV 16, 39 and 59 was observed at Month 84. Cervical cytology results were negative at subsequent visits; In boys, there were no cases of vaccine-targeted HPV type disease (penile intraepithelial neoplasia (PIN)), certain studied cancers (penile, perineal, perianal) or external genital warts observed. GARDASIL 9 is not approved for the prevention of HPV-related PIN, penile, perineal or perianal cancers. No GARDASIL 9-related serious adverse events or deaths were reported throughout the LTFU study. The most common reasons for discontinuations from the LTFU study were due to participant withdrawal or loss to follow-up. HPV will infect most sexually active males and females in their lifetime. For most people, HPV clears on its own, but for those who don’t clear the virus it could lead to certain cancers and other diseases. In the United States, the CDC estimated that tens of thousands of people were diagnosed with certain HPV-related cancers each year from 2015-2019. And worldwide, cervical cancer is the fourth most common cancer in women. There is no way to know which people who have HPV will develop cancer or other health problems. With the exception of cervical cancer, there is no routinely recommended screening for the detection of HPV-related cancers. About the study The Phase 3 immunogenicity study for GARDASIL 9 in boys and girls aged 9–15 years was extended to a LTFU study to assess immunogenicity through 10 years after the last GARDASIL 9 vaccine dose. The LTFU study was conducted at 40 sites across 13 countries: Belgium, Brazil, Colombia, Costa Rica, Peru, Poland, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand and USA. There were 1,272 participants (971 girls, 301 boys) enrolled in the LTFU study. Analysis of the per-protocol population included 872 girls and 262 boys who completed the GARDASIL 9 vaccination series within one year, were seronegative to the relevant HPV type at initiation of the vaccination series and had not initiated sexual activity prior to receiving the third dose of GARDASIL 9. The primary objective of the LTFU study was to evaluate anti-HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 antibody responses through 10 years post the third dose of GARDASIL 9. Secondary objectives were to estimate the long-term incidence of the composite endpoint of HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58-related persistent infection (≥6 months duration ±1 month visit window) and disease. Safety assessments during the LTFU study included reporting of all deaths and vaccine-related serious adverse events. Indication for GARDASIL 9 GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. GARDASIL 9 has not been demonstrated to provide protection against diseases caused by: HPV types not covered by the vaccine HPV types to which a person has previously been exposed through sexual activity Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN). Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients. Select Safety Information GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Because vaccines may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL 9 have not been established in pregnant women. The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema. The duration of immunity of a 2-dose schedule of GARDASIL 9 has not been established. Dosage and Administration GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh. For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months. For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). Please see Prescribing Information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at and Patient Information/Medication Guide for GARDASIL 9 at

Studies backed the company’s key electrophysiology and cardiac rhythm management therapies, plus the Watchman FLX device. In addition to the LAAC device, the Marlborough, Massachusetts-based company shared data on its Farapulse PFA system, POLARx cryoablation system and the Emblem MRI subcutaneous implantable defibrillator (S-ICD). Boston Scientific presented all data at Heart Rhythm Society’s (HRS) Heart Rhythm 2023 meeting in New Orleans. “The data shared at this year’s Heart Rhythm meeting showcases the breadth and depth of our cardiology therapies, which spans from diagnosis to treatment of cardiac disease, and highlights the continued growth of our portfolio,” said Dr. Kenneth Stein SVP and global chief medical officer, Boston Scientific. “From preclinical data to real-world surveillance, data demonstrated positive outcomes for our Farapulse PFA System, the POLARx cryoablation system, the Emblem S-ICD system as well as our Watchman FLX LAAC device, and is evidence of our commitment to providing physicians with innovative technologies that make a meaningful impact on the lives of patients living with heart disease.” Real-world data backs the Farapulse system Boston Scientific presented real-world outcomes from the multi-center EU-PORIA registry for the Farapulse system. This registry demonstrated the safety, efficacy and learning curve characteristics of Farapulse. In 2021, Boston Scientific acquired Farapulse and its PFA technology for nearly $300 million. Data included favorable single procedure success rates, plus efficient procedure times in a broad patient population. The registry evaluated more than 1,200 patients with paroxysmal or persistent AFib across seven high-volume European centers. Boston Scientific reported a 74% rate of freedom from recurrence of AFib and atrial tachycardia. This was measured by the Kaplan-Meier estimate at a median follow-up of one year. Freedom from recurrence rate came in at 80% in patients with paroxysmal AFib and 66% in those with persistent AFib. The level of physician experience with AFib ablation did not impact procedure times or patient outcomes. Boston Scientific said this reinforces the procedural reproducibility of the Farapulse PFA system. Data demonstrated a predictable workflow with a median of 58 minutes within an interquartile range of 40 to 87 minutes. The study saw a 1.7% major complication rate and 1.9% minor complication rate. It observed no reported esophageal damage or pulmonary vain stenosis, with a single case of sustained phrenic nerve palsy. That report came from the MANIFEST PF study. Boston Scientific reports primary results from cryoablation study The prospective, non-randomized, single-arm FROZEN-AF investigational device exemption (IDE) study evaluating the POLARx cryoablation system met its safety and effectiveness endpoints, Boston Scientific said. This study evaluated the device in treating paroxysmal or intermittent AFib. It included an extension arm for the POLARx FIT cryoballoon catheter. This single device has capabilities for enabling 28mm and 31mm sizes. The extension arm sub-study also achieved its safety and effectiveness endpoints. That included 50 patients treated with at least one application of the 31mm cryoballoon set for 12-month follow-up. At the time of data release, patients underwent six of a total 12 months of follow-up. FROZEN-AF achieved its primary safety endpoint of composite acute and chronic primary safety events through 12 months. It observed an event-free rate of 96.3% at 12 months in the IDE trial and 100% at six months in the extension. Boston Scientific received no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy or esophageal fistulas in either patient cohort. Rate of freedom from documented atrial arrhythmias came in at 79.9% at 12 months in the IDE trial. It registered at 88% at six months in the extension. Using the Emblem MRI S-ICD for tricuspid regurgitation and ventricular tachycardia (VT) Boston Scientific also reported data from a secondary analysis of the investigator-sponsored, randomized ATLAS trial. It included 450 patients. The study evaluated the severity of tricuspid regurgitation at six months following the implantation of a transvenous implantable cardioverter-defibrillator (TV-ICD) versus the Emblem MRI S-ICD. Data showed that, at six months, patients in the TV-ICD group proved seven times more likely to present worsening tricuspid regurgitation. Of those with worsening tricuspid regurgitation, moderate or severe symptoms developed in 6.9% of TV-ICD patients. That compared to just 2.3% in the Boston Scientific S-ICD group. Meanwhile, data from the investigator-sponsored VTabl-SICD trial evaluated the safety and efficacy of a novel hybrid management strategy combining VT ablation with S-ICD implantation in patients who have scar-related VT. It evaluated 32 patients. Data suggested that the combination strategy proved superior to conventional IV-ICD implantation. This occurred in the secondary prevention of sudden cardiac death. Boston Scientific said the combination strategy significantly reduced the need to deliver ICD therapy. It also proved effective for avoiding untreated, symptomatic arrhythmias. At two years, the rate of delivery of any appropriate ICD therapy proved significantly lower in the VTabl-S-ICD group. No cases of untreated symptomatic VT or ventricular fibrillation appeared in the VTabl-S-ICD group. New developments for Watchman FLX Boston Scientific also presented data from two new sub-analysis of the SURPASS study. This study, out of the National Cardiovascular Data Registry (NCDR) LAAO Registry, provided insights into real-world treatment strategies with Watchman FLX. The first analysis assessed outcomes with different post-procedural antithrombotic therapies. It demonstrated that patients treated with direct oral anticoagulants (DOAC) alone had the lowest risk of major adverse events in comparison to other drug regimens following the implant. Boston Scientific’s second analysis demonstrated that concomitant catheter ablation and LAAC with Watchman FLX proved safe. It demonstrated similar outcomes compared to device implantation alone. The company also said the latest preclinical data for the investigational Watchman FLX Pro device demonstrated that its new thromboresistant coating may further reduce the risk of device-related thrombus and result in faster and more uniform tissue coverage on the device at 45 days post-implant. The findings were also published in JACC Clinical Electrophysiology.