News & Trends - Medical Technology

Boston Scientific’s world-first single-use duodenoscope

Health Industry Hub | January 13, 2020 |
[Total: 1    Average: 5/5]

Boston Scientific announced approval of the EXALT™ Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures.

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.

This groundbreaking device has been developed as an alternative to reusable duodenoscopes, eliminating the need for duodenoscope reprocessing and repairs, and allowing physicians to use a new, sterile device for every procedure. The EXALT Model D Duodenoscope builds on the familiar design of standard reusable duodenoscopes so that physicians experience a minimal learning curve when adopting this technology.

Every year, more than 1.5 million ERCPs are performed worldwide using duodenoscopes to diagnose and treat various pancreatic and biliary conditions.

Reusable duodenoscopes are put through a rigorous disinfection process between uses in different patients and the vast majority of procedures with these devices are carried out safely and effectively; however, there have been a small number of cases in which infections have been transmitted between patients via contaminated devices, despite adherence to established protocols.

As a result, the FDA has been working with duodenoscope manufacturers, medical societies, physicians and other stakeholders to address this concern. The FDA recently issued a recommendation that healthcare providers transition to duodenoscopes with disposable components or fully disposable devices, when they are available, and held an advisory committee meeting to discuss this process and other issues related to reducing infection transmission by reusable duodenoscopes.

Build thought leadership, differentiate your organisation and let us help you connect with the Australian Pharma, MedTech and Biotech industry professionals. Health Industry Hub offers unique media solutions to vendors and suppliers servicing the industry. Contact us.

“The EXALT Model D Duodenoscope was developed to support clinicians in their mission to deliver the highest quality patient care,” said Art Butcher, senior vice president and president, Endoscopy, Boston Scientific.

Boston Scientific conducted a consecutive case series of the EXALT Model D Duodenoscope and found that expert endoscopists were able to complete ERCPs across a wide range of complexity using the single-use duodenoscope.

“With the EXALT Model D Duodenoscope, I can perform the same high-quality ERCP procedure with the added benefit of using a brand-new sterile device for each patient,” said Dr. Raman Muthusamy, Medical Director of Endoscopy, Professor of Clinical Medicine, David Geffen School of Medicine at UCLA. “I believe the development of this device is a significant advancement in the evolution of endoscopy.”

The company plans to commence a limited market release of the device in the U.S. during the first quarter of 2020.

Register FREE to receive the latest news, innovations and insights from Health Industry Hub; the only one-stop-hub connecting Australia’s Pharma, MedTech and Biotech industry professionals and its key stakeholders.


About the author

About the author

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Nam luctus finibus scelerisque. Nunc bibendum ipsum sed augue fringilla fringilla. Nullam at consectetur leo. Praesent viverra rutrum porta. Quisque vitae mi vel purus vulputate tincidunt. Class aptent taciti sociosqu ad litora torquent per conubia nostra, per inceptos himenaeos. Suspendisse et mi quis nisi rhoncus feugiat at ac tellus. Sed aliquam sodales nulla ac auctor. Sed pretium lobortis purus accumsan ullamcorper. Phasellus sodales vel odio in lobortis. Duis maximus sagittis bibendum. Interdum et malesuada fames ac ante ipsum primis in faucibus. Nunc dictum tincidunt ipsum in vestibulum. Donec ut sem consectetur, aliquam quam vitae, pharetra orci. Nam egestas non velit eu rhoncus. Duis congue neque non lacus tincidunt porta. Vestibulum ultricies pulvinar sem, molestie congue dui aliquet non.
  • Ut imperdiet leo id lorem fermentum consectetur.
  • Ut vitae orci et dui varius tincidunt.
  • Ut id magna non libero vestibulum pharetra ac faucibus nulla.
Aliquam erat volutpat. Vestibulum vitae varius diam. Nulla eget congue ante. Nunc ullamcorper sagittis augue vel dictum. Mauris finibus nibh ut pulvinar auctor. Vestibulum ut faucibus nisi. Orci varius natoque penatibus et magnis dis parturient montes, nascetur ridiculus mus. Quisque porta tortor ac justo malesuada elementum. Nulla tellus ante, cursus nec ex sit amet, suscipit bibendum arcu. Duis posuere orci dui, et mollis enim dictum at. Sed ullamcorper, sapien ut vulputate viverra, sem purus porttitor tellus, nec mattis mauris ligula sed risus. Nulla sagittis id ipsum eu mattis. Link to full profile

Social Responsibility

Social Responsibility and Community Engagement - World Cancer Day 2020

World Cancer Day 2020

Health Industry Hub | January 22, 2020 |

People across Australia will come together on 4 February to reduce the impact of cancer around the world. 2020 marks […]

More


News & Trends - Pharmaceuticals

Pharma Medical News - TGA reveals new regulatory science strategy 2020-2025

TGA reveals new regulatory science strategy 2020-2025

Health Industry Hub | January 22, 2020 |

New technologies such as gene therapies, other cell and tissue therapies, 3D-printing, and software as a medical device are transforming […]

More


Marketing & Strategy

Biopharma marketing - embracing change for growth

Biopharma marketing – embracing change for growth

Health Industry Hub | January 22, 2020 |

For years, biopharma companies have celebrated their “patient centricity”, yet only 35% of patient groups say that the industry is […]

More


News & Trends - Medical Technology

MedTech News - Medtronic to launch a game changer for patients with neurological disorders

Medtronic to launch a game changer for patients with neurological disorders

Health Industry Hub | January 22, 2020 |

Medtronic announced the CE Mark for Percept PC neurostimulator; it is the only Deep Brain Stimulation (DBS) system to be […]

More