Pharma Focus America

Stimdia Medical Inc. Commences FDA-Cleared IDE Pivotal Study to Explore the Impact of Neuromuscular Stimulation on Patients Requiring Mechanical Ventilation

Wednesday, October 04, 2023

Stimdia Medical, a company specializing in innovative medical devices to enhance respiratory care, has announced the commencement of an FDA-approved pivotal trial. This trial aims to investigate the impact of phrenic nerve stimulation (PNS) on reducing the duration of mechanical ventilation for patients.

This study, known as the "ReInvigorate Study," is designed as a randomized, controlled trial and will include approximately 420 ICU patients currently on mechanical ventilation. Patients will be randomly assigned to one of two groups: those receiving PNS therapy using Stimdia's proprietary pdSTIMTM System and those receiving standard care without PNS.

The primary objective of the ReInvigorate Study is to assess the efficacy of PNS therapy in expediting liberation from mechanical ventilation, with the goal of improving outcomes for critically ill patients.

Dr. Kyle Cunningham, a trauma and critical care physician at Atrium Health – Carolinas Medical Center, shared his enthusiasm for the therapy, stating, We are pleased to have enrolled the inaugural participant in the ReInvigorate Study. It's an exciting opportunity to explore this innovative therapy in patients struggling with regaining independent breathing. This minimally invasive approach has the potential to address some of the challenges commonly associated with current ventilation methods. We are optimistic that this therapy can bring about significant improvements in the lives of our patients.

Dr. Steven Conrad, who serves as the National Principal Investigator for the ReInvigorate Study and is affiliated with Louisiana State University's Division of Critical Care Medicine, added, The pdSTIM System presents a unique approach to managing ICU patients, offering support to physicians, respiratory therapists, and nurses in expediting the liberation of patients from mechanical ventilation. I eagerly anticipate clinicians incorporating this therapy into the study and await the trial's results as it progresses.

The pdSTIM System employs a minimally invasive procedure to place small leads near the phrenic nerves on both sides of the neck. These leads connect to an external console that synchronizes therapy delivery with inhalation. The device's settings can be customized to deliver electrical impulses at specific frequencies and intensities. These impulses aim to stimulate and rehabilitate the diaphragm, the primary muscle involved in breathing. Strengthening the diaphragm is considered a potential pathway to accelerate the weaning of patients from mechanical ventilation.

Stimdia Medical CEO Tim Miller expressed excitement about their collaboration with a distinguished group of clinicians for this pivotal trial. He emphasized its potential to improve outcomes for critically ill patients, stating, We are enthusiastic about partnering with this exceptional team of clinicians to launch this pivotal trial, which aims to explore the potential of PNS in enhancing the outcomes of critically ill patients. We believe that the pdSTIM therapy holds promise for revolutionizing respiratory care, and we are committed to making this therapy accessible to patients as soon as possible.

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