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Boston Scientific Corporation (BSX) delivers innovative medical solutions through advanced devices for cardiovascular care, neuromodulation, and minimally invasive procedures. This news hub provides investors and healthcare professionals with timely updates on regulatory milestones, product innovations, and strategic initiatives shaping the future of patient care.
Access official press releases covering clinical trial results, FDA clearances, and financial performance alongside analysis of emerging trends in interventional therapies. Our curated collection includes updates on electrophysiology advancements, urological device developments, and global healthcare partnerships.
Key updates feature Boston Scientific's leadership in catheter-based technologies, progress in chronic pain management solutions, and expansions in diagnostic imaging capabilities. Stay informed about acquisitions, research collaborations, and quality improvement initiatives that reinforce the company's market position.
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Boston Scientific (NYSE: BSX) announced results from the ACURATE IDE clinical trial evaluating their ACURATE neo2™ Aortic Valve System for treating severe aortic stenosis. The trial's primary endpoint showed a 16.16% composite rate of all-cause mortality, stroke, or rehospitalization at one year in the ACURATE neo2 arm versus 9.53% in the control arm, failing to meet non-inferiority criteria. A post-hoc analysis revealed approximately 20% of valves were under-expanded, with data showing similar outcomes between properly expanded ACURATE neo2 valves and the control group. The company continues working with the FDA on regulatory approval strategy.
Boston Scientific (BSX) reported strong Q3 2024 results with net sales of $4.209 billion, representing a 19.4% increase year-over-year. The company achieved adjusted EPS of $0.63, exceeding guidance of $0.57-$0.59. Notable segment growth includes Cardiovascular at 25.0% and MedSurg at 10.3%. Regional performance showed U.S. sales growth of 23.5% and EMEA growth of 15.2%. The company received multiple regulatory approvals, including FDA approval for the FARAWAVE™ NAV Ablation Catheter and completed the acquisition of Silk Road Medical. For full-year 2024, BSX projects net sales growth of approximately 16.5% on a reported basis.
Boston Scientific (NYSE: BSX) has received FDA approval for the FARAWAVE™ NAV Ablation Catheter and FDA 510(k) clearance for the FARAVIEW™ Software. These technologies enhance the FARAPULSE™ Pulsed Field Ablation (PFA) System for treating paroxysmal atrial fibrillation (AF).
The FARAWAVE NAV Ablation Catheter adds magnetic navigation capabilities, allowing cardiac mapping and PFA therapy delivery in a single integrated catheter. The FARAVIEW Software provides visualization for cardiac ablation procedures, offering a dynamic view of catheter placement, shape, and rotation.
These advancements are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures. The FARAPULSE PFA System has been used to treat over 125,000 patients globally. Boston Scientific will immediately launch these new technologies in the U.S.
Boston Scientific (NYSE: BSX) has announced two upcoming events:
1. A conference call on October 23, 2024, at 8:00 a.m. ET to discuss third quarter 2024 financial results and business highlights. The call will be hosted by Mike Mahoney, chairman and CEO, and Dan Brennan, executive VP and CFO. Financial results will be released prior to the call.
2. A virtual investor event on October 30, 2024, from 4:00 – 5:00 p.m. ET following the Transcatheter Cardiovascular Therapeutics (TCT) symposium. This event will feature a cardiology business update and Q&A session with key executives from the company's cardiology division.
Live webcasts and replays for both events will be available on the Boston Scientific investor relations website.
Boston Scientific (NYSE: BSX) has received PMDA approval in Japan for the FARAPULSE™ Pulsed Field Ablation (PFA) System. This system is indicated for the isolation of pulmonary veins in treating paroxysmal atrial fibrillation (AF). Unlike traditional thermal ablation, the FARAPULSE PFA System uses non-thermal electrical fields, avoiding damage to surrounding structures.
The system has been used to treat over 125,000 patients globally and is now approved in more than 65 countries. AF affects over one million people in Japan and an estimated 38 million worldwide. Boston Scientific plans to launch the system in Japan following reimbursement approval and expects to initiate the OPTION-A clinical trial in early 2025 to study concomitant procedures using the FARAPULSE PFA System and the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device.
Boston Scientific (NYSE: BSX) has completed its acquisition of Silk Road Medical, Inc. (Nasdaq: SILK) for $27.50 per share, representing an enterprise value of approximately $1.18 billion. This acquisition strengthens Boston Scientific's vascular technology solutions by integrating the innovative transcarotid artery revascularization (TCAR) platform for stroke prevention and carotid artery disease treatment.
The deal is expected to have a minimal impact on Boston Scientific's adjusted earnings per share in 2024 and 2025, becoming accretive thereafter. The impact on GAAP earnings may be less favorable due to amortization expenses and acquisition-related charges. This strategic move aims to expand the availability of TCAR to more physicians and patients through Boston Scientific's extensive commercial network.
Boston Scientific (NYSE: BSX) has received FDA approval to expand the indication for its INGEVITY™+ Pacing Leads to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA). This expansion allows for an alternative to traditional right ventricular pacing in treating symptomatic bradycardia. The LBBA pacing approach may promote greater ventricular synchrony and reduce long-term heart failure risk.
The approval was supported by data from the INSIGHT-LBBA study, involving approximately 400 patients. The INGEVITY+ Pacing Lead, which received initial FDA approval in 2019, features a stylet-driven design for precise positioning and continuous pacing and impedance monitoring capabilities.
Boston Scientific (NYSE: BSX) has obtained CE mark for its ACURATE Prime™ Aortic Valve System, a new transcatheter aortic valve replacement (TAVR) technology. This system expands treatment options for patients with larger anatomy and is designed for low, intermediate, and high-risk patients with severe aortic stenosis. Key features include:
- An enhanced frame for stable fit
- Redesigned deployment mechanism for accurate positioning
- Expanded treatment range (aortic annulus diameters 20.5-29 mm)
- Low pacemaker and paravalvular leak rates
- Strong hemodynamic performance
- Unrestricted coronary access for future procedures
The ACURATE Prime system will be launched in Europe in the coming weeks, building on the success of the ACURATE platform, which has been implanted in nearly 80,000 patients globally.
Boston Scientific (NYSE: BSX) has announced its participation in Wells Fargo's 2024 Healthcare Conference on September 4, 2024. The company's chairman and CEO, Mike Mahoney, along with Dr. Brad Sutton, chief medical officer of Atrial Fibrillation Solutions, will engage in a 35-minute Q&A session with the host analyst, starting at approximately 8:00 a.m. ET.
Investors and interested parties can access a live webcast of the session through the Boston Scientific investor relations website. A replay of the event will be made available about an hour after its conclusion, providing an opportunity for those unable to attend the live session to catch up on the discussion.
Boston Scientific (NYSE: BSX) has announced the election of David Habiger to its board of directors, effective immediately. Habiger brings over 30 years of business leadership experience and currently serves as president and CEO of J.D. Power. He has previously led several technology companies and is a director on the Chicago Federal Reserve Board. Boston Scientific's CEO, Mike Mahoney, welcomed Habiger, citing his experience in leading technology companies through pivotal growth periods as a valuable asset to the company's board.
Habiger's extensive background includes founding Silicon Media Partners and serving as CEO for companies like Textura, NDS Group, and Sonic Solutions. He holds an M.B.A. from The University of Chicago and a bachelor's degree in business administration from St. Norbert College. His appointment is expected to contribute to Boston Scientific's ongoing efforts to deliver transformative healthcare solutions.