TransAeris Diaphragm Pacing

Background

​

Mechanical ventilation (MV) although life-saving, can also be harmful:

• MV and sedation cause the disused diaphragm muscle to atrophy rapidly and profoundly (ventilator induced diaphragm dysfunction; VIDD*)

• Positive-pressure ventilation often damages the lungs (ventilator induced lung injury; VILI) and may lead to ventilator associated pneumonia (VAP)

• MV requires intubation and depending on the injury or illness may require a tracheostomy whenever mechanical ventilation has to continue for a longer period of time

• Ventilated patients are at high risk of contracting nosocomial (hospital-acquired) bacterial and fungal infections

* Levine S, Nguyen T, et al. “Rapid Disuse Atrophy of Diaphragm Fibers in Mechanically Ventilated Humans” N Engl J Med 358: 1327-35, 2008

​

VIDD, VILI and VAP are key contributing factors to the frequent difficulty in weaning patients from the ventilator. About 31% of patients on MV are categorized as ‘difficult to wean’ when they fail one or more spontaneous breathing trials or need to be re-intubated within 48 hours of extubation.

About 35% of ventilated patients require prolonged weaning periods of over 96 hours, and over 20% are still on MV at 7 days. These are the most expensive patients in the hospital. The U.S. cost of prolonged MV patients in 2020 is projected to exceed $60 Billion**. When a patient becomes ventilator-dependent, their risk of dying in the ICU increases 7-fold.

** Zilberberg, Prolonged acute mechanical ventilation and hospital bed utilization in 2020 in the United States: implications for budgets, plant and personnel planning. BMC Health Services Research, 2008, 8:242.

​

TransAeris

The TransAeris™ System is a temporary percutaneous intramuscular diaphragm stimulator intended for patients at risk of or on prolonged positive pressure mechanical ventilation. TransAeris is indicated for use in the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD). The primary components of the TransAeris System include the TransLoc®electrodes and the external TransAeris stimulator. Up to two TransLoc® electrodes are inserted into each, right and left, hemi-diaphragm.

TransAeris is used to provide neuromuscular electrical stimulation to the diaphragm while the patient is on mechanical ventilation to prevent, slow, or reverse diaphragm disuse atrophy and, more generally, to treat VIDD. Once the patient is successfully extubated after mechanical ventilation, the electrodes are removed from the patient. The entire system is disposed of after single patient use, to avoid any transfer of nosocomial infections in the ICU environment.

TransAeris System consists of Patient Kit and Electrode Kit:

Patient Kit:

• (1) TransAeris external stimulator with color coded patient cable

• (2) FrictionLoc connectors.

• (2) Pair surface patch electrodes (4 total surface patches)

Electrode Kit:

• (20) TransLoc electrode leads (4 electrodes needed per patient)

TransAeris Stimulator

TransAeris™ is a percutaneous intramuscular diaphragm stimulator, designed for temporary single use diaphragm pacing. TransAeris has built in user interface for clinical control.

FrictionLoc Connector

The FrictionLoc connector is the interface between the percutaneous electrodes and the patient cable. The FrictionLoc connector cables are color coded and keyed. (Left side of patient = Blue and Right side of patient = Green).

Surface Patch Electrodes

Surface patch electrodes are connected to FrictionLoc connectors and allow for the adherence of FrictionLoc to patient’s skin.

TransLoc Electrodes

TransLoc electrodes are designed using 316 Stainless Steel and other biocompatible materials. The design of the TransLoc Electrodes has been developed with anchoring for temporary implantation. A curved needle is integrated to allow for implantation of the electrode intramuscularly to the diaphragm. A tunneling needle is integrated to allow for lateral externalization of the electrode.