Author: Rasa Zarnegar
Fidmi Medical received FDA approval for Low-profile Enteral Feeding Device on October 16th, 2019.
Fidmi Medical has developed a Low-profile Enteral Feeding Device that is a percutaneous gastrostomy tube placed endoscopically similar to the conventional PEG tubes. Conventional feeding tubes tend to get dislodged or clogged requiring replacement frequently. This novel device has several features that enhance patient comfort, reduce issues with clogging, and accidental dislodgment.
To enhance patient comfort and reduce dislodgement, the rigid core internal bumper combines flexibility with structure designed to stay in place at skin level, and reduce stoma injury. As such, routine dislodgment is unlikely and patient comfort increased by reduction of need for managing tubes. The disposable feeding tube insert can be replaced by patients or caregiver easily in the event of clogging avoiding patients return for replacement and costly medical expenditure. When the device requires removal, the internal bumper breaks into pieces internally, decreasing patient discomfort.
The Fidmi device underwent bench testing to demonstrate that the device performs as intended and is substantially equivalent to a predicate device, the EndoVive™ One-Step Button™ and replacement tube.
The Fidmi Low Profile Enteral Feeding Device is intended for use when enteral nutrition is required. The device cannot be used when gastrostomy feeding is contraindicated (ex: high aspiration risk or gastroparesis). The Fidmi Low Profile Enteral Feeding Device replaceable tube is intended for use only with the Fidmi Low Profile Enteral Feeding Device.