The paragraph details a Boston Scientific Cardiology Business Update webcast. It introduces key members of the Cardiology leadership team, including Joe Fitzgerald and others. Joe Fitzgerald discusses the current and projected market size for cardiology procedures performed in the cath lab, estimating it to be nearly $40 billion with an 8% CAGR until 2027. He highlights the growth in various segments, noting a shift away from reliance on DES and defibrillators to multiple growth areas. Year-to-date growth rates mentioned are 27% in the U.S. and 18% internationally, with specific growth drivers outlined.

The paragraph discusses the performance and developments in the cardiology sector of the company in Q3. It highlights accelerated growth in the ICTx and EP businesses and solid growth in the WATCHMAN franchise. A key update is the approval and rollout of the FARAVIEW mapping software and the FARAWAVE NAV catheter in multiple accounts, showcasing improvements in cost-efficiency and workflow. Lance Bates, the President of Interventional Cardiology Therapies, then discusses market growth expectations, projecting an 8% growth rate through 2027 and emphasizing the diversification of their portfolio away from drug-eluting stents towards broader interventional cardiology tools. The AGENT launch in the U.S. is mentioned as another exciting development.

The paragraph discusses the company's continued success and growth projections in various healthcare markets. The firm aims to double its global drug-coated balloon business by 2025 and is experiencing growth in complex PCI markets despite not yet including IVL in its offerings. The complex PCI business has surpassed their drug-eluting therapies, with notable success in their calcium portfolio, especially Rotablator and WOLVERINE, leading to mid-teens growth in the U.S. for Q3. Their PCIG segment, including IVUS capital equipment, is also thriving, capturing over 50% market share with the AVVIGO+ platform. Additionally, the TAVR market shows strong prospects, particularly in the EMEA region with the ACURATE platform, where they have surpassed $200 million in revenue and reported close to 20% growth. Their newly launched Prime platform is gaining traction due to favorable clinical performance features.

The paragraph discusses the company's progress and investments in the mechanical circulatory support space, highlighting the completion of the EFS for the VITALYST system and plans to start the IDE in the U.S. by 2025. It emphasizes the integration and effectiveness of their portfolio, specifically mentioning the AVVIGO and AVVIGO+ platforms, which enhance imaging and procedure efficiency using AI technology. The company also notes that their IVUS imaging, launched in 45 countries, has received a Class 1A indication in ESC guidelines. The underlying philosophy is that understanding the nature of the treatment is crucial in determining the preparation and treatment approach, whether it involves stents, drug-coated balloons, or other methods.

The paragraph discusses the high usage rate of IVUS (96%) in AGENT cases and the use of a calcium preparation device in 100% of these cases, highlighting the integration of the calcium treatment and IVUS portfolio. It mentions plans for further investment in clinical trials for conditions like long lesions, small vessel disease, and ACS patients, suggesting an opportunity for growth beyond using a drug-eluting stent as first-line therapy. Additionally, it announces the start of the AGENT IDE trial for a 40-millimeter long lesion, with the first patient enrolled, and transitions to Janar Sathananthan discussing the ACURATE IDE trial.

The paragraph discusses a large prospective randomized controlled trial involving 1,500 patients divided into two groups to evaluate the ACURATE neo2 valve against two other commercial valves, Evolut and Sapien, in the United States. The primary composite endpoint was a combination of all-cause mortality, stroke, or rehospitalization at one year, with planned follow-up for ten years. The trial, the largest head-to-head TAVR study, faced complexities like the COVID-19 pandemic, slow enrollment over four years, supply constraints, and low operator experience, affecting 75% of implanters. Although a Bayesian analysis showed a noninferiority margin of 6.63%, it did not meet the primary endpoint's prespecified noninferiority margin. A post-hoc analysis assessed all cases involving ACURATE neo2.

The paragraph discusses inconsistencies identified in the procedural steps for valve expansion, specifically pre and post-dilatation, which deviated from commercial practices in other markets. These inconsistencies impacted valve expansion, with approximately 20% of cases experiencing severe underexpansion. It highlights that expanded ACURATE neo2 valves showed better outcomes compared to underexpanded ones, with lower rates of death and stroke that were comparable to control groups. The paragraph emphasizes that the engineering team identified mechanisms for these outcomes, noting that clinically relevant valve thrombosis was significantly less with the ACURATE platform compared to the control.

The paragraph discusses the impact of valve expansion in heart procedures, highlighting that a well-expanded valve, resembling a Mercedes-Benz sign, results in symmetrical blood flow, whereas underexpanded valves lead to turbulent flow and impaired leaflet movement. This underscores the importance of expanded valves. The ACURATE Prime platform, recently launched, includes a new size for a larger patient population and enhancements to improve radial force and ease of use. Additionally, relevant data from the TCT conference is mentioned, including a U.S. cohort study of the SENTINEL device from the PROTECTED TAVR trial.

The paragraph discusses post-hoc analysis findings showing a reduced rate of overall and disabling strokes at 72 hours in a U.S. cohort, with patients less likely to need extra services and more likely to return home. No major safety issues were noted. It highlights the launch and expansion of the AGENT drug-coated balloon in the U.S., showing consistent benefits across three patient subgroups (minorities vs. whites, males vs. females, and different vessel sizes) from the AGENT IDE trial. Additionally, it reports on the WATCHMAN FLX Pro device's HEAL LAA clinical study, which successfully met its primary safety and efficacy endpoints. The paragraph concludes by summarizing key data presented at TCT 2024 and transitions to a Q&A session.

The paragraph features a Q&A session with Robbie Marcus from JPMorgan asking about potential negative impacts on sales in Europe due to trial results and issues with physician training during the trial. Lance Bates responds that they are pleased with the platform's performance in Europe, where there is significant experience, and they are maintaining a 20% growth rate. They plan to continue monitoring the situation and support European physicians. Janar Sathananthan addresses the training concern, explaining that the issue with underinflating relates to the ACURATE platform's pre-dilatation balloon sizing. The trial, which began in 2019, faced challenges during the COVID pandemic, affecting external support for physicians.

The paragraph discusses a series of questions during a Q&A session regarding the regulatory pathway and data presentation for a medical trial involving the ACURATE Prime system. Jonathan Monson fields questions from various analysts, including Travis Steed, Vijay Kumar, and Matt O'Brien, about issues such as supply chain impacts, data presentation timelines at an upcoming London Valves event, and the expected filing of data with the FDA. Janar Sathananthan and Joseph Fitzgerald address these concerns, noting ongoing discussions with the FDA about regulatory procedures and data requirements, while emphasizing the unpredictability of the exact needs for an original PMA submission.

The paragraph discusses the significance and potential of investing in a domestic Transcatheter Aortic Valve Replacement (TAVR) program in the U.S. Lance Bates argues that the TAVR market remains compelling and crucial for being a comprehensive player in the structural heart field, emphasizing their investments in related devices. Joseph Fitzgerald reflects on their long-term strategy in electrophysiology (EP) and desires to be a leading cardiology company, noting the SHV market's value and growth. The discussion touches upon challenges with FDA pathways and a specific clinical trial's impact, with Janar Sathananthan addressing a question about valve size in the ACURATE IDE trial by Danielle Antalffy from UBS.

The paragraph discusses the launch of the Prime design in Europe, highlighting its increased radial force strength by 20%, which may impact expansion. The mitigation strategy includes procedural corrections, such as appropriate pre- and post-dilatation, to address any underexpansion. Joseph Fitzgerald asks Janar Sathananthan to elaborate on what this means for the ACURATE platform. Janar explains that underexpansion is a growing topic in the TAVR field, similar to past issues in the stent era where imaging and optimization were emphasized. The ACURATE IDE trial showed better gradients and no concerns about leaks compared to balloon-expandable valves. Overall, recognizing and correcting expansion will be crucial for TAVR advancements.

In this Q&A segment from a discussion, Vijay from Evercore asks about the issue of why a normally expanded valve might show underexpansion a year after a TAVR procedure, and whether this relates to valve design, such as radial force. Janar Sathananthan responds, noting that echo is not ideal for assessing expansion and that a simple fluoroscopic method has been identified to detect and address underexpansion during the procedure itself. The conversation then shifts to post-dilatation concerns, with Sathananthan emphasizing the importance of using a balloon size 1 millimeter below the perimeter drive diameter, which was not adhered to in many cases in a specific trial. Despite this, evidence from Europe reveals single-digit pacemaker rates with the ACURATE valve platform. Jonathan Monson acknowledges and then introduces the next question from Larry Biegelsen of Wells Fargo.

The paragraph features a discussion on the transition from the Neo2 platform to the Prime platform, which is being commercially launched in Europe and has superior clinical benefits. Lance Bates emphasizes their commitment to working with the FDA for the ACURATE Prime platform in the U.S. and other markets. The conversation also touches on the integration of AI in imaging, specifically for interpreting CT scans, with plans for future software enhancements in the AVVIGO+ system to assist physicians. Additionally, Janar Sathananthan comments on the positive impact of IVUS imaging in planning procedures and commits to updating the system with AI. The segment ends with a brief mention of a question about the utilization of embolic protection data relating to SENTINEL.

The paragraph discusses the challenges and considerations associated with a sub-study and post-hoc analysis of a negative study regarding the ACURATE technology. It highlights the need for further evidence and understanding of the technology's utility. It is explained that out of 1,500 patients, only around 700 were analyzed due to imaging limitations, focusing on the test group rather than the control. The conversation touches on the potential path toward FDA approval for the Prime platform used in transcatheter aortic valve replacement (TAVR) and its potential impact on approval in other regions like Japan, with ongoing discussions with the FDA.

The paragraph discusses interactions with regulatory authorities in Japan, China, and the U.S. for clinical trials related to the ACURATE IDE. Joseph Fitzgerald mentions the need for similar conversations with each regulatory body. Kenneth Stein comments on the Inari PEERLESS data, stressing the importance of interventional therapies for pulmonary embolism and comparing EKOS to standard care. He notes that objective measures like mortality and hemorrhage showed no differences between study arms, affirming confidence in EKOS and awaiting HI-PEITHO study results. Finally, Travis Steed from Bank of America asks for more details on the FARAWAVE launch.

The paragraph discusses the impact of the FARAWAVE and OPAL launches on mapping and market share. Joseph Fitzgerald explains that FARAWAVE's versatility allows it to be used in various workflows across different regions, such as fluoro-only in Germany and fluoro aided by ICE in the Czech Republic. In the U.S. and Spain, most FARAWAVE cases involve mapping. The launch of FARAVIEW and the integration of FARAWAVE 2.0 is expected to significantly increase their market share in mapping. This is due to the dual-functionality of the FARAWAVE catheter on the FARAVIEW system as both a mapping and ablation tool, the unique dynamic visualization capabilities offered by their proprietary platform, and their exclusive lesion targeting and tracking features.

The paragraph discusses a company's strategic decisions and progress in ongoing medical trials and investments. They explain that their integrated system differs from competitors', allowing them to potentially capture more of the FARAWAVE market. Despite suspending enrollment in a specific study, they continue enrolling in the extended durability cohorts due to FDA collaboration and improved operator training. The discussion also touches on the company's investments in mitral and tricuspid valve technologies, indicating a strong venture capital portfolio and collaborations, though specific details are not disclosed.

The paragraph discusses the company's strategic investment approach in therapies, particularly in mitral repair and potential opportunities in replacement. They highlight the significance of electrosurgery, especially as structural heart procedures become more complex. Additionally, opportunities stemming from new heart failure drugs are noted. The focus is on long-term success and value of the company's portfolio and franchise. The speaker, Jonathan Monson, concludes the webcast, invites further questions, and provides details for accessing a replay of the presentation.

This summary was generated with AI and may contain some inaccuracies.