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

MassDevice

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

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Boston Scientific touts 3-year Solyx stress urinary incontinence mesh trial data

Boston Scientific touts 3-year Solyx stress urinary incontinence mesh trial data

October 12, 2018 By Fink Densford

Boston Scientific

Boston Scientific (NYSE:BSX) this week released three-year data from a study of its Solyx single incision sling system intended to treat stress urinary incontinence, touting that the trial met all primary and secondary endpoints.

Boston Scientific said it presented the full results from the trial yesterday at the annual scientific symposium of the American Urogynecologic Society.

The Marlborough, Mass.-based company said it enrolled a total 281 patients in the trial at 21 sites looking to compare efficacy and adverse events for non-inferiority of the Solyx system versus the gold-standard transobturator mid-urethral sling procedure.

The study was part of a post-market surveillance trial required by the FDA to be performed by all manufacturers of mesh products, Boston Scientific said. The company touted it as the first of three such studies it will complete, with remaining data expected to be released next year.

“This trial exemplifies our rigorous commitment to patient safety and our drive to positively impact the lives of the 31 million women with pelvic floor disorders. Our journey doesn’t stop there. We have invested in 16 additional pelvic floor studies to continue building the body of clinical evidence for our women’s health products, including mesh sling systems,” Boston Scientific medsurg prez David Pierce said in a press release.

The primary endpoint in the trial was treatment success defined by a composite of objective measure and any subjective self-reported improvement in stress urinary incontinence using the Patient Global Impression of Improvement at three years. Secondary endpoints included adverse events and indication of reoperation or retreatment.

Results indicated that the group treated with the SIS was deemed non-inferior to the TMUS group in composite treatment success with both intention-to-treat and per protocol analysis. Treatment success rate was 90.4% in the SIS group, versus 88.9% in the TMUS group. Rates of procedure or device-related serious adverse events at three years amongst SIS groups were non-inferior to the TMUS group, Boston Scientific said.

“These findings provide a high degree of evidence supporting the safety and effectiveness of the Solyx SIS System, as compared to transobturator mid-urethral sling (TMUS) procedures, and reinforce the use of a minimally invasive procedure for SUI. The results have the potential to impact millions of women with SUI by offering confirmation about the Solyx SIS System as a viable, first-line surgical treatment option for these patients,” study principal investigator Dr. Amanda White of the University of Texas Dell Medical School said in a prepared statement.

Last month, Boston Scientific said it launched its LithoVue Empower retrieval deployment device designed to be used with the LithoVue single-use digital flexible ureteroscope during ureteroscopic kidney stone retrieval procedures.

Filed Under: Clinical Trials, Featured, Urology, Women's Health Tagged With: Boston Scientific

In case you missed it

  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
  • Teva appoints former Vertex exec as new head of R&D, CMO
  • Enovis partners with Kelvi on hot and cold therapies
  • West Pharmaceutical Services debuts new needle syringe system
  • Titan Medical names Cary G. Vance as new president, CEO
  • Acutus completes first closing in left-heart access portfolio sale to Medtronic
  • FDA clears Intuitive, Siemens Healthineers imaging integration for robotic bronchoscopy
  • FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall
  • How safe is health information after the overturning of Roe?
  • Smith+Nephew opens new plant in Malaysia
  • BD launches combination COVID-19, flu, RSV diagnostic test
  • Zimmer Biomet creates independent nonprofit organization to reduce health disparities
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
  • Nasdaq grants Titan Medical 180-day extension to regain compliance
  • Aerin Medical reports positive 4-year results for VivAer treatment
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
  • How medical device companies are responding to abortion bans

RSS From Medical Design & Outsourcing

  • Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future
    All eyes are on Medtronic’s global operations and supply chain leader as he works to modernize its operations and scrutinize suppliers. EVP of Global Operations and Supply Chain Greg Smith anticipates fewer suppliers in Medtronic’s future, he said in an interview this week. Smith spoke with DeviceTalks Editorial Director Tom Salemi in his first published… […]
  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
    CeQur designed its Simplicity device to make insulin delivery as seamless as possible for people with diabetes. When it comes to managing diabetes, CeQur wants to make insulin therapy as convenient as possible. For those who prefer to manage their own insulin delivery, the Simplicity device might just do exactly that. Simplicity, a wearable, disposable… […]
  • Meddux opens new facility in Colorado
    Engineering, design, development and manufacturing company Meddux announced that it opened a new facility in Boulder, Colorado. The new, 22,000-square-foot facility doubles the overall square footage from its previous location in Colorado. According to a news release, it helps the company to quadruple its product development area and double its manufacturing footprint. Meddux’s new facility… […]
  • Reducing the Overall Cost of Validation
    By PTI Engineered Plastics Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification… […]
  • BBS Automation has a deal to buy medtech supplier Kahle Automation
    BBS Automation said it plans to purchase high-speed automation supplier Kahle Automation to expand its medtech and life sciences business. Kahle will operate as Kahle – a BBS Company, according to a news release from Munich, Germany-based BBS and Lombardy, Italy-based Kahle. The deal is subject to regulatory approval. Terms were not disclosed. Kahle’s co-owners —… […]
  • How safe is health information after the overturning of Roe?
    The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade. Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge… […]
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
    New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s… […]
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
    Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt… […]
  • How medical device companies are responding to abortion bans
    Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access. Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately. Some medtech companies are not using… […]
  • Philips updates on testing results for recalled ventilators
    Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after its… […]
  • ResMed names Lucile Blaise as new Sleep & Respiratory Care leader
    Lucile Blaise will be the new president of ResMed’s Sleep & Respiratory Care business starting July 1, ResMed (NYSE: RMD) said today. She replaces Jim Hollingshead, who became president and CEO of Insulet (Nasdaq:PODD) on June 1. ResMed President and COO Rob Douglas is serving as interim president of the Sleep & Respiratory Care during… […]

Primary Sidebar

DeviceTalks Weekly

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MEDTECH 100 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.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

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

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · 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.

Advertise | Privacy Policy | RSS