Stimdia Medical Receives FDA Breakthrough Device Designation for the pdSTIM™ System Designed to Facilitate Weaning Patients from Mechanical Ventilation

Stimdia Medical, Inc., an emerging leader in the development of technology to reduce weaning time for patients on mechanical ventilation, today announced the companys pdSTIM System has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).

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Thursday, March 18, 2021
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FDA, Health, Medical devices, Medical specialties, Respiratory therapy, Medicine, Health care, Ventilator, Mechanical ventilation, Food and Drug Administration, FDA, Health, Medical devices, Medical specialties, Respiratory therapy, Medicine, Health care, Ventilator, Mechanical ventilation, Food and Drug Administration
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Minnesota, United States, United States, Minnesota, MINNEAPOLIS, MN
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STIMDIA MEDICAL
Summary
Key Points: 
  • Stimdia Medical, Inc., an emerging leader in the development of technology to reduce weaning time for patients on mechanical ventilation, today announced the companys pdSTIM System has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
  • Mechanical ventilation is an essential intervention and is utilized in the management of over 10 million patients throughout the world each year.
  • Receiving FDA Breakthrough Device designation for the pdSTIM System will help prioritize the process for obtaining regulatory authorization in the U.S., said Tim Miller, General Manager, Stimdia Medical.
  • We believe the pdSTIM System will help to reduce both length of stay and costs by enabling more rapid weaning of patients from mechanical ventilators.


Please replace the release with the following corrected version due to revisions.

The updated release reads:

STIMDIA MEDICAL RECEIVES FDA BREAKTHROUGH DEVICE DESIGNATION FOR THE PDSTIM™ SYSTEM DESIGNED TO FACILITATE WEANING PATIENTS FROM MECHANICAL VENTILATION

Stimdia Medical, Inc., an emerging leader in the development of technology to reduce weaning time for patients on mechanical ventilation, today announced the company’s pdSTIM™ System has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for products that offer unique potential for difficult to treat conditions and affords manufacturers greater access and priority to the FDA during the regulatory process. This system will provide clinicians a tool to address high risk patients, including those with COVID-19, by providing a minimally invasive neurostimulation solution to recondition the diaphragm, the primary muscle utilized in respiration.

“Mechanical ventilation is an essential intervention and is utilized in the management of over 10 million patients throughout the world each year. Unfortunately, they are also associated with a significant risk of complications. Ventilator-induced diaphragmatic dysfunction or VIDD is one common complication resulting from a weakened diaphragm due to disuse while on ventilation,” stated Daniel Talmor, M.D., Professor of Anesthesia and Critical Care at Beth Israel Deaconess Medical Center. “This impaired state further compromises the ability to liberate patients from mechanical ventilation and increases patient morbidity, mortality, and healthcare costs.”

“Receiving FDA Breakthrough Device designation for the pdSTIM System will help prioritize the process for obtaining regulatory authorization in the U.S.,” said Tim Miller, General Manager, Stimdia Medical. “Over 40% of ICU admissions in the U.S. require mechanical ventilation with an average length of stay of 14 days for ventilated patients and an estimated annual cost of over $27 billion. We believe the pdSTIM System will help to reduce both length of stay and costs by enabling more rapid weaning of patients from mechanical ventilators.”

About Stimdia Medical

Stimdia Medical, Inc. is a privately held company headquartered in Minneapolis, MN and has developed the pdSTIM System to facilitate in weaning patients suffering from ventilator-induced diaphragmatic dysfunction (VIDD). The pdSTIM System is currently for investigational use only and is not for sale in any country.

For more information, visit www.stimdia.com

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