Boston Scientific Corporation develops and markets less invasive medical devices and therapies used by healthcare professionals and institutions globally. News about BSX centers on operating results, business highlights, capital-structure updates and product developments across cardiovascular, respiratory, digestive, oncological, neurological and urological care.
Recurring company updates include clinical evidence and regulatory milestones for platforms such as FARAPULSE pulsed field ablation, WATCHMAN left atrial appendage closure, EKOS endovascular therapy and the Asurys Fluid Management System. Coverage also reflects conference presentations, FDA clearances, trial results and management discussions of quarterly performance across the company’s medical-technology portfolio.
Boston Scientific Corporation (NYSE: BSX) received FDA 510(k) clearance for its EXALT Model B Single-Use Bronchoscope, intended for bedside procedures in ICU and OR settings. The bronchoscope enhances suction performance and imaging quality, available in three sizes. With over 1.2 million annual procedures using bronchoscopes in the U.S., the single-use design mitigates infection risks associated with reusable devices. Limited market release is expected soon following the completion of CE marking in May 2021.
Boston Scientific has launched the HI-PEITHO clinical trial, investigating the efficacy of the EkoSonic Endovascular System combined with anticoagulation for treating acute, intermediate-high-risk pulmonary embolism (PE). The trial, enrolling up to 544 patients across 65 sites in the U.S. and Europe, aims to compare outcomes against anticoagulation alone. Nearly one million patients are impacted by PE annually in the U.S. and Europe, emphasizing the trial's significance. The study follows patients for a year to assess adverse events and improve clinical guidelines for PE treatment.
Boston Scientific (NYSE: BSX) received a New Technology Add-on Payment (NTAP) from the U.S. Centers for Medicare & Medicaid Services (CMS) for its EXALT™ Model D Single-Use Duodenoscope, effective October 1, 2021. This reimbursement will enhance access to this technology for Medicare patients, who constitute over 40% of ERCP procedures in the U.S. The duodenoscope aims to reduce infection risks associated with traditional reusable models, aligning with FDA recommendations for more disposable options.
Boston Scientific Corporation (BSX) reported second quarter 2021 net sales of $3.077 billion, a 53.6% year-over-year increase. GAAP net income reached $172 million or $0.12 per share, recovering from a loss of $153 million last year. Adjusted EPS soared to $0.40, beating expectations. Growth was driven by strong sales across segments: MedSurg (64.6%), Rhythm and Neuro (65.0%), and Cardiovascular (51.4%). The company also initiated European launches for new medical devices and expanded its electrophysiology portfolio.
Boston Scientific (NYSE: BSX) announced positive 24-month results from the PINNACLE FLX clinical trial for the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. The trial, presented at TVT: The Structural Heart Summit, involved 400 patients with non-valvular atrial fibrillation (NVAF). It showed a rate of ischemic stroke or systemic embolism of 3.4%, significantly better than the 8.7% performance goal. The trial confirms the device's safety and efficacy, with favorable outcomes including no significant complications. The WATCHMAN FLX device has received FDA approval and is widely adopted in the U.S. and Europe.
Boston Scientific Corporation (NYSE: BSX) will host a conference call on July 27, 2021, at 8:00 a.m. EDT to discuss its financial results for Q2 2021. The call will feature Mike Mahoney, CEO, and Dan Brennan, CFO. A news release detailing the financial results will be issued prior to the call. Interested parties can access the live webcast and replay at investors.bostonscientific.com, starting one hour after the call's conclusion.
Boston Scientific Corporation (NYSE: BSX) has announced the election of David S. Wichmann to its board of directors as of June 24, 2021. Wichmann previously served as the CEO of UnitedHealth Group from 2017 to 2021, with a career at the company spanning 23 years. His expertise includes enhancing patient outcomes and reducing healthcare costs. CEO Mike Mahoney expressed optimism about Wichmann's insights contributing to innovation at Boston Scientific. This move emphasizes the company's commitment to strengthening leadership that can drive growth and improve healthcare solutions.
Boston Scientific (NYSE: BSX) announced its decision to acquire the remaining shares of Farapulse, Inc. The acquisition, valued at approximately $295 million for a 73% stake, will enhance Boston Scientific's electrophysiology portfolio by incorporating the FARAPULSE Pulsed Field Ablation (PFA) System for treating cardiac arrhythmias. The deal may expand earnings but is expected to be slightly dilutive to adjusted EPS in 2021 and 2022. The transaction is set to close in Q3 2021, pending customary conditions.
Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for its EXALT™ Model B Single-Use Bronchoscope, targeting ICU, OR, and bronchoscopy suite procedures. A limited market release will start in Europe in June 2021. The bronchoscope comes in three sizes and offers enhanced imaging and suction capabilities, addressing infection risks associated with reusable scopes. Over 1.5 million bronchoscopies are performed annually in Europe. This innovation aims to improve patient safety and hospital efficiency, as single-use scopes are preferred for eliminating contamination risks.
Boston Scientific Corporation (NYSE: BSX) will participate in Bernstein's 37th Annual Strategic Decisions Conference on June 4, 2021. The event will feature a virtual 45-minute Q&A session with key executives including Mike Mahoney, Susie Lisa, and Lauren Tengler, starting at approximately 8:00 a.m. EDT. Investors can access a live webcast on the Boston Scientific Investor Relations website, with a replay available one hour after the event concludes.