Boston Scien Cp - BSX STOCK NEWS

Boston Scientific (NYSE: BSX) has launched the ACURATE neo2™ Aortic Valve System in Europe, enhancing transcatheter aortic valve implantation (TAVI) technology. This system offers expanded indications for patients with aortic stenosis, includes new annular sealing technology to minimize paravalvular regurgitation, and simplifies access to complex vessels. Clinical data suggests improved outcomes, with 97.5% of patients experiencing mild or no paravalvular leakage at one year. The system is investigational in the U.S., assessed in the ACURATE IDE trial.

Boston Scientific (BSX) announced an investment agreement for an exclusive option to acquire Farapulse, a company developing a pulsed field ablation system for atrial fibrillation (AF). This innovative system uses electric fields instead of thermal energy to ablate cardiac tissue, offering a more precise treatment method. The FDA granted Breakthrough Designation to Farapulse in May 2019, accelerating its path to market. Boston Scientific's investment aligns with its strategy to enhance its electrophysiology product portfolio, catering to the needs of AF patients.

Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval and initiated a limited market release of its Vercise Genus™ Deep Brain Stimulation (DBS) System in Europe as of September 9, 2020. This system, designed for treating Parkinson's disease, essential tremor, and dystonia, features MRI compatibility and Bluetooth capabilities. With advanced directional stimulation and new clinician software, the Vercise Genus aims to optimize therapy for over 10 million people affected by Parkinson's globally. Notably, the system is not available for use in the United States.

Boston Scientific (NYSE: BSX) announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for its Eluvia Drug-Eluting Vascular Stent System, effective October 1, 2020. This designation allows eligible hospitals to receive additional reimbursement for up to three years, enhancing access for patients with peripheral artery disease (PAD). The Eluvia stent system demonstrates superior clinical outcomes, showing lower rates of repeat procedures compared to competitors. This payment support is crucial for improving patient care and boosting hospital incentive.

Boston Scientific (NYSE: BSX) will participate in two virtual investor conferences on September 9 and September 16, 2020. CEO Mike Mahoney will join a Q&A session at the Wells Fargo 2020 Virtual Healthcare Conference, starting at 9:20 a.m. EDT. On September 16, Mahoney, CFO Dan Brennan, and IR VP Susie Lisa will participate in a similar session at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference, beginning at 8:00 a.m. EDT. Live webcasts and replays will be available on the company's investor relations website.

BTG Specialty Pharmaceuticals, a division of Boston Scientific (NYSE:BSX), announced that the European Medicines Agency (EMA) has accepted its Marketing Authorisation Application (MAA) for Voraxaze® (glucarpidase). This application aims to authorize Voraxaze® for treating adults and children at risk of methotrexate toxicity due to delayed elimination. The MAA is underpinned by clinical data and real-world experience, having previously treated nearly 3,000 patients in the US since FDA approval in 2012. A decision from the EMA could lead to marketing authorization across the EU and additional countries.

Boston Scientific reported Q2 2020 sales of $2.003 billion, marking a decline of 23.9% year-over-year. The company faced a GAAP loss of $147 million or $(0.11) per share, a drop from earnings of $154 million or $0.11 per share in the prior year. Adjusted EPS was $0.08, down from $0.39. Sales declined across all segments due to the COVID-19 pandemic, with declines of 29.6% in MedSurg and 33.2% in Rhythm and Neuro. The company received multiple FDA approvals, boosting its product pipeline.

Boston Scientific received FDA approval for the WATCHMAN FLX Left Atrial Appendage Closure Device, aimed at reducing stroke risk in patients with non-valvular atrial fibrillation. This next-generation device enhances maneuverability and offers a fully recapturable and repositionable design. Positive results from the PINNACLE FLX study showed a 0.5% major complication rate and high effectiveness with 100% effective closure at 12 months. The device is available in broader sizes, increasing its market potential. A limited launch in the U.S. is set to commence.

Boston Scientific Corporation (NYSE: BSX) will host a conference call on July 29, 2020, at 8:00 a.m. EDT, to discuss its second-quarter financial results for the period ending June 30, 2020. The call, led by CEO Mike Mahoney and CFO Dan Brennan, will include insights on business highlights. The company plans to release its financial results prior to the call. Investors can access the call and its replay on the Boston Scientific Investor Relations website.