Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

French Study Of NeuRx® Diaphragm Pacing System (DPS) In Off-Label ALS Patients Confirms: NeuRx DPS® Should Be Used With NIV In Later Stage Of Disease

October 17, 2016 By Synapse Biomedical Inc.

NeuRx DPS: electrodes size vs dime, externally EPG unit, image of wire placement in the diaphragm. (Credit: PR NewsWire)

Synapse Biomedical Inc. (www.synapsebiomedical.com) announced  that the results of a small French trial (RespiStimALS), designed to assess the NeuRx® Diaphragm Pacing System (DPS) in newly diagnosed ALS patients, were published in Lancet Neurology.

The French trial, which consisted of 74 patients, studied the use of DPS to delay the need for noninvasive ventilation (NIV) (e.g. BiPaP, Trilogy). All patients were implanted earlier than usual, close to their initial diagnosis. Half the patients had their device activated at surgery. The other half, the control patients, had their device activated much later, at the usual time, once they met criteria for NIV. The trial results reported by the authors showed that early implantation was ineffective. However, the trial does nothing to contradict the previous conclusion that on-label DPS use, at the usual later time, concomitant with NIV use, improves survival.

The AAN Practice Parameter for ALS has long recommended noninvasive ventilation (NIV) to slow respiratory decline, lengthen survival, and improve quality of life.  When NIV was used in conjunction with NeuRx DPS®, survival was significantly improved (by 16 months) according to the published FDA Summary of Safety and Probable Benefit for NeuRx DPS®. In contrast, the French study patients were treated with DPS alone, without NIV, well before they would be indicated to receive either DPS or NIV in the U.S.

“This would not be a group of patients we would offer NeuRx DPS® in the U.S.  The device was approved, by the FDA, for people who have documented chronic hypoventilation from ALS and still have intact diaphragm lower motor neurons (LMN) and motor units as identified with pre-operative and intra-operative testing,” stated Raymond Onders, M.D., Professor of Surgery, Remen Chair in Surgical Innovation, University Hospitals Cleveland Medical Center. He further stated, “We purposely submitted to the FDA for approval in this select, later-stage, ALS population. The French study results support our selection criteria and early implantation is not beneficial.”

Waiting until chronic hypoventilation allows the surgeon to identify which parts of the diaphragm have preserved phrenic motor function—i.e., remains stimulable. Dr. Onders went on to say, “We can condition the diaphragm by stimulating the remaining viable phrenic motor units. During disease progression, optimal electrode implantation site changes.  Early implantation not only precludes optimal placement but disallows differentiation between UMN and LMN involvement.  In both situations; suboptimal electrode site or predominant LMN involvement, diaphragm pacing would have no benefit.  Since both the active and control groups in the French study were implanted too early, both groups could be expected to have suboptimal results.  The results of this study do not really inform our current, real-world, on-label use of NeuRx DPS®.” 

“The French study results are in stark contrast with the median post-implant survival of 19.7 months in the lead-in controlled, prospective, IDE pivotal study (n=85) and median post-implant survival of 20.9 months in the current U.S. PAS study (n=60).  With proper selection, these 145 study patients survived much longer than the off-label French study patients. Thus, there must be important differences in the respective study populations or in clinical practices.  We are confident in the safety and therapeutic utility of DPS when patients are carefully selected and screened according to proper, current, criteria,” said Anthony Ignagni, President & CEO.

 

Related Articles Read More >

A portrait of Dr. Philip Adamson
Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
iRhythm stays silent on federal grand jury subpoenas
iRhythm stock soars on Street-beating Q1
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

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.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech