Synapse Biomedical NeuRx Diaphragm Pacing System™

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

EMERGO SINGAPORE CONSULTING PRIVATE LIMITED

Class:

Class C medical device

Manufactured by:

Synapse Biomedical Inc.

Therapeutic area:

General Hospital

Therapeutic indications:

The NeuRx Diaphragm Pacing System™ (NeuRx DPS™) provides ventilatory support in patients with diaphragm dysfunction of neuromuscular origin. Diaphragm dysfunction can result in abnormal or absent respiration in patient populations of high-level spinal cord injury, central hypoventilation, amyotrophic lateral sclerosis, and other injuries or diseases affecting the neuromuscular respiratory pathways. The device is indicated in patients with high-level spinal cord injury, whose remaining phrenic nerve, lung and diaphragm muscle function are sufficient to accommodate electrical stimulation.

Product summary:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], Only the surgical kit contains EO sterilized components (as below). Indifferent Electrode Lead Tunnelers Cable Set Trocar to Transducer Tubing PermaLoc Electrode, 60cm Touchproof Cable (Green/Orange/Yellow/White); Models: NeuRx DPS System Kit - 20-0030, NeuRx DPS Surgical Kit - 20-0018, NeuRx Diaphragm Pacing System Patient Kit, 2-EPG - 20-0024, System Destination Kit, 2-EPG - 20-0063, NeuRx DPS Surgical Site Start-up Kit - 20-0039, NeuRx Diaphragm Pacing System Clinical Station Kit - 20-0038, Electrode Delivery Tool - 22-0018, Clinician Connector Kit - 22-0029, Surgical Connector Kit - 22-0028, Surgical Tool Replacement Parts kit - 22-0015

Authorization date:

2022-10-26