On Saturday, Boston Scientific Corporation BSX unveiled three-year primary endpoint results from the OPTION global clinical trial of the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device.The WATCHMAN implant device is about the size of a quarter and shaped like a parachute. It is implanted into the heart to close off the left atrial appendage, a blind pouch of heart tissue to prevent blood clots from forming and causing a stroke.Key findings from the study comparing the device to first-line oral anti ...

Clinical Trial Results - The WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device demonstrated superiority to oral anticoagulation (OAC) in reducing non-procedural major bleeding or clinically relevant non-major bleeding at 36 months (8.5% vs. 18.1%; P<0.0001) [2] - The device showed non-inferiority to OAC for the primary efficacy endpoint of all-cause death, stroke, or systemic embolism at 36 months (5.4% vs. 5.8%; P<0.0001) [2] - The WATCHMAN FLX device also demonstrated non-inferiority for the combined secondary endpoint of procedural and non-procedural major bleeding at 36 months (3.9% vs. 5.0%; P<0.0001) [2] Patient Population and Procedure Details - The OPTION trial included 1,600 patients across 114 sites in the United States, Europe, and Australia [4] - Approximately 60% of device patients had their WATCHMAN FLX implant 90-180 days following their ablation procedure, while nearly 40% had the two procedures performed concomitantly [4] - The trial focused on patients with non-valvular atrial fibrillation following a cardiac ablation, comparing the device to first-line OAC, including direct oral anticoagulants (DOAC) (95%) and warfarin (5%) [1] Clinical Implications - The OPTION trial data suggest that LAAC with the WATCHMAN FLX device is not only as safe but superior to OAC therapy for reducing the risk of long-term bleeding events in patients who have undergone an ablation [4] - High rates of procedural success and patient adherence to prescribed medication regimens were observed, contributing to low rates of ischemic and hemorrhagic stroke within the trial population [4] - The trial results indicate potential for the WATCHMAN FLX platform to become a frontline therapy for patients receiving cardiac ablation for atrial fibrillation to reduce stroke risk [5] Ongoing and Future Research - The WATCHMAN technology is being evaluated against DOAC as a first-line therapy in lower-risk patients within the CHAMPION-AF randomized trial [5] - The latest-generation WATCHMAN FLX™ Pro LAAC Device, approved in the United States in 2023, is being studied in several clinical trials, including the SIMPLAAFY randomized controlled trial [5] Company Background - Boston Scientific Corporation is a global medical technology leader with over 45 years of experience, providing solutions for cardiovascular, respiratory, digestive, oncological, neurological, and urological diseases [7] - The company aims to improve patient health and reduce healthcare costs through innovative medical technologies [7]

Boston Scientific Corporation Conference Call Summary Company Overview - **Company**: Boston Scientific Corporation (NYSE: BSX) - **Event**: UBS Global Healthcare Conference - **Date**: November 12, 2024 Key Points Financial Performance - **Q3 2024 Organic Revenue Growth**: 18.2% [3] - **Adjusted Operating Margin**: 27.2% [3] - **Earnings Per Share (EPS) Growth**: 27% in Q3 2024 [3] - **2024 Guidance**: Raised to 15% organic revenue growth, with an expected operating margin expansion of 70 basis points to approximately 27% [3] - **2024 Adjusted EPS Growth Guidance**: 20% to 21% [3] Growth Catalysts - **Key Growth Drivers**: WATCHMAN and Electrophysiology (EP) business, particularly FARAPULSE, which is transforming the atrial fibrillation (AF) ablation market [4] - **Market Position**: Company aims to be the highest-performing large-cap med tech company with broad-based growth across all business segments [4] FARAPULSE and AF Ablation Market - **Adoption Rate**: Accelerated adoption of electroporation technology with FARAPULSE, exceeding initial expectations [7] - **Market Share**: Tracking ahead of the projected 40% to 60% of ablation procedures being performed with PFA by 2026 [6] - **User Experience**: Positive feedback on ease of use and safety, leading to rapid rebooking of patients [8] - **Competitive Landscape**: Company maintains a first-mover advantage in the PFA market, with ongoing innovation to fend off competition [10][12] WATCHMAN Device - **Clinical Trial**: OPTION trial comparing WATCHMAN to oral anticoagulants for stroke prevention in post-AFib ablation patients [24] - **Market Potential**: Positive trial results could expand the indicated patient population by 1 million to 2 million, increasing the market size from $1.7 billion to $6 billion by 2030 [25] - **Indication Expansion**: Anticipated submission for indication expansion in the second half of 2025, with potential to increase the indicated patient pool from 4 million to 18 million by 2030 [30] International Market Opportunities - **Expansion into Asia**: Launching in China and Japan in 2025, with both markets representing a multibillion-dollar opportunity [38] - **Market Dynamics**: Each market has unique characteristics, and the company is well-positioned to capture share due to strong supply chain and manufacturing capabilities [41] Innovation and Product Development - **New Products**: Introduction of FARAWAVE mapping system and continued innovation in PFA technology [23][54] - **Future Trials**: Plans for additional trials like ADVANTAGE and AVANT GUARD to expand indications and enhance product offerings [54][48] Competitive Moat - **Market Share**: Company holds over 90% market share for WATCHMAN, with ongoing innovation to maintain leadership [31][32] - **Clinical Evidence**: Strong focus on generating clinical evidence to support product efficacy and safety [33] Capacity and Treatment Trends - **Capacity Management**: Hospitals are adapting by increasing the number of electrophysiologists and cath labs to meet growing demand for AF ablation procedures [51] - **Ambulatory Surgery Centers**: Potential future growth in treating patients in outpatient settings [52] Summary Boston Scientific is experiencing robust growth driven by its innovative products in the electrophysiology and left atrial appendage closure markets. The company is well-positioned for future expansion, particularly in international markets, and is focused on maintaining its competitive edge through continuous innovation and clinical evidence generation.

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Core Viewpoint - Boston Scientific Corporation has announced a definitive agreement to acquire Cortex, Inc., enhancing its electrophysiology portfolio with a new diagnostic mapping solution aimed at improving treatment for complex atrial fibrillation (AF) cases, which affects nearly 38 million people globally [1][2]. Group 1: Acquisition Details - The acquisition of Cortex is expected to complement Boston Scientific's existing electrophysiology offerings by providing a differentiated cardiac mapping solution for complex AF cases [2]. - The OptiMap™ System developed by Cortex utilizes a basket catheter and proprietary algorithm to identify potential active AF sources, allowing for a more individualized ablation strategy [1][2]. - The transaction is anticipated to close in the first half of 2025, subject to customary closing conditions, and is expected to have an immaterial impact on adjusted earnings per share in 2025 [3]. Group 2: Clinical Evidence and Technology - Cortex's OptiMap System received FDA 510(k) clearance in 2023 and has shown promising results in clinical trials, including a 51% improvement in freedom from AF one year post-ablation compared to conventional therapies [2]. - A global clinical trial named RESOLVE-AF has been initiated to further evaluate the effectiveness of the OptiMap System in identifying extra-pulmonary vein sources [2]. Group 3: Company Vision and Future Plans - The CEO of Cortex expressed that joining Boston Scientific will enable further development of their technology, which has the potential to transform AF treatment globally [3]. - Boston Scientific aims to advance the OptiMap technology and generate future clinical evidence to make it accessible to physicians and patients worldwide [2].

Boston Scientific Corporation (NYSE:BSX) Business Update Summary Company Overview - **Company**: Boston Scientific Corporation - **Industry**: Medical Devices, specifically focusing on Cardiology - **Conference Date**: October 30, 2024 Key Points and Arguments Market Overview - The cardiology market is valued at nearly **$40 billion**, with a projected **8% CAGR** through the end of 2027 [4][10] - Year-to-date growth rates are **27% in the U.S.** and **18% internationally** [6] Product Performance - The company has seen accelerated growth in its **Interventional Cardiology Therapies (ICTx)** and **Electrophysiology (EP)** businesses, alongside solid growth from the **WATCHMAN franchise** [6] - The **AGENT drug-coated balloon** is expected to double the global business by **2025** compared to **2024** [12] - The **ACURATE platform** has achieved over **$200 million** in revenue in EMEA, with growth approaching **20%** [15] Regulatory and Clinical Updates - The **ACURATE IDE trial** was a large randomized controlled trial involving **1,500 patients**, comparing the ACURATE neo2 valve to other commercial valves [26] - The primary endpoint of the trial was not met, but post-hoc analysis indicated that valve under-expansion was a significant issue, affecting outcomes [29][30] - The **ACURATE Prime platform** has been launched, which includes enhancements that increase radial force by **20%** and expands the eligible patient population by **20%** [39] Technology and Innovation - The **AVVIGO+ platform** incorporates AI for real-time measurements in the cath lab, enhancing the clinical viability of IVUS imaging [19] - The **FARAWAVE mapping software** has been launched, which integrates mapping and ablation capabilities, expected to increase market share in the mapping segment [84][86] Future Outlook - The company is committed to expanding its structural heart portfolio, including investments in **tricuspid and mitral therapies** [90][92] - Ongoing discussions with the **FDA** regarding the regulatory pathway for the ACURATE Prime platform and potential additional studies [52][58] Financial Performance - The company is diversifying its portfolio away from drug-eluting stents, which now account for less than **5%** of total sales [11] - The **complex PCI market** is now larger than the drug-eluting therapies business, valued at over **$4 billion** [13] Additional Important Insights - The company emphasizes the importance of physician training and procedural adherence to mitigate issues like valve under-expansion [50][60] - The integration of imaging technologies is seen as critical for improving procedural outcomes and enhancing the overall treatment pathway [20][70] - The company is actively monitoring the impact of trial results on sales, particularly in Europe, where they have a strong market presence [47][48] This summary encapsulates the key insights from the Boston Scientific earnings conference call, highlighting the company's market position, product performance, regulatory updates, and future strategies in the cardiology sector.

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Boston Scientific (BSX) is gaining traction in the international markets. New regulatory approvals and accretive acquisitions bode well for long-term growth. The stock carries a Zacks Rank #2 (Buy) currently.Factors Driving BSX SharesBoston Scientific continues to successfully expand operations across different geographies outside the United States. In 2023, 41% of the company’s consolidated revenues came from international regions. In Europe, Middle East and Africa (EMEA), Boston Scientific has been succes ...

TCT 2024 Investor Update October 30, 2024 DCIENTIIIC Advancing science for life™ Safe harbor for forward-looking statements This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "may," "intend" and similar words. These forward-looking statements are based on our beli ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File No. 1-11083 BOSTON SCIENTIFIC CORPORATION (Exact name of registrant as specified in its charter) Delaware 04-2695240 (State or other jurisdiction of incorporation ...