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Boston Scientific Advises CMS Granted a New Technology Add-on Payment for the Eluvia™ Drug-Eluting Vascular Stent System

Boston Scientific notes the NTAP designation, awarded to new medical devices determined to substantially improve the diagnosis or treatment of Medicare beneficiaries, will be effective on October 1, 2020 and will provide eligible hospitals with incremental reimbursement for the Eluvia stent system for up to three years.

FDA Approves Next-generation WATCHMAN FLX LAAC Device Announces BSX

The next-generation WATCHMAN FLX™ LAAC Device is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage – the area of the heart where stroke-causing blood clots commonly form in NVAF.

Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac Monitor System

The new LUX-Dx™ Insertable Cardiac Monitor System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making.

DIRECTSENSE™ Technology Launched by Boston Scientific

Available on the RHYTHMIA HDx™ Mapping System, the DIRECTSENSE Technology, which received U.S. Food and Drug Administration approval in April, is the only tool to monitor changes in local impedance – electrical resistance – around the tip of the INTELLANAV™ MiFi Open-Irrigated (OI) ablation catheter, offering physicians an additional measurement of therapy effect during an ablation.

PINNACLE FLX Study of the WATCHMAN FLX™ Left Atrial Appendage Closure Device Presented as Late-Breaking Clinical Trial at HRS 2020 SCIENCE

Presented as a late-breaking clinical trial at HRS 2020 SCIENCE, the study evaluated performance of the WATCHMAN FLX™ device as an alternative to oral anticoagulation therapy, including non-vitamin K antagonist oral anticoagulants (NOACs), for stroke risk reduction in patients with NVAF.

New Clinical Study Results Demonstrate Rezūm is Proven to Give Men Suffering with BPH Sustained Symptom Relief and Quality of Life Improvements for 5...

The supplement, available online now, includes standard and late-breaking abstracts for the American Urological Association (AUA) Annual Meeting.

World’s First Single-Use Duodenoscope, EXALT™ Model D Receives FDA Clearance

The EXALT Model D Duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device.

Tactra™ Malleable Penile Prosthesis Launched by Boston Scientific

The new penile prosthesis is the first new innovation in penile implants in more than 10 years and represents an evolution in the design of malleable penile implants to offer the patient and his partner a more authentic, natural-feeling erection.