• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Boston Scientific touts S-ICD data from long-term safety & efficacy study

Boston Scientific touts S-ICD data from long-term safety & efficacy study

April 21, 2015 By Brad Perriello

Boston Scientific touts S-ICD data from long-term safety & efficacy study

Boston Scientific (NYSE:BSX) yesterday touted a study published in the Journal of the American College of Cardiology showing the long-term safety and effectiveness of its S-ICD "leadless" defibrillator.

The study pooled 6-month to 1-year data from a pair of Boston Scientific-funded clinical trials, the S-ICD investigational device exemption trial and the Effortless post-market trial.

The JACC study followed 882 patients implanted with the S-ICD device, which Boston acquired when it bought Cameron Health for $1.35 billion in 2012, for 651 ± 345 days. There were 111 spontaneous ventricular tachyarrhythmia/ventricular fibrillation events treated in 59 patients, 100 of which (90.1%) were ended with 1 shock and 109 (98.2%) of which were ended within the 5 available shocks, according to the study.

The estimated 3-year inappropriate shock rate was 13.1%. Estimated 3-year, all-cause mortality was 4.7% (95% confidence interval: 0.9% to 8.5%), with 26 deaths (2.9%). Device-related complications cropped up in 11.1% of patients at 3 years. There were no electrode failures and no S-ICD–related endocarditis or bacteremia. Three devices (0.3%) were replaced for right ventricular pacing, according to the study.

The researchers, all of whom reported receiving support from Boston Scientific, concluded that the S-ICD "demonstrated high efficacy" for VT/VF, with complications and inappropriate shock rates "reduced consistently with strategic programming and as operator experience increased," according to the JACC study.

"These data provide further evidence for the safety and efficacy of the S-ICD," they wrote.

"The S-ICD device sits just below the skin without the need for electrodes or leads to be placed into the heart and so it makes sense that we see decreased serious complications," lead author Dr. Martin Burke of the University of Chicago said in prepared remarks. "By using the S-ICD System we can avoid the key risks that cause systemic or endovascular infections, which can add weeks to a hospital stay, incur tens of thousands of dollars in incremental hospital costs, and which are also associated with mortality for up to one-third of TV-ICD patients who acquire this type of infection."

Filed Under: News Well Tagged With: Boston Scientific, Cardiac Rhythm Management, Clinical Trials, Journal of the American College of Cardiology

More recent news

  • A new way to monitor glucose: Glucotrack explains 3-year CBGM implant technology
  • Dexcom continues advances in AI for CGM, type 2 diabetes awareness
  • Tandem continues to deliver more options, benefits for those with diabetes
  • Breaking: Sequel to launch twiist automated insulin delivery system next month
  • Dexcom shares U.S. report on CGM benefits for type 2 diabetes

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy