Product Description
Laryngeal Umbrella KeelThe Laryngeal Umbrella Keel is a medical device used in the treatment of various laryngeal conditions. It is designed to prevent stenosis following a hemilaryngectomy and to aid in the formation of a sharp anterior commissure. Here are some key points about the Laryngeal Umbrella Keel:
- Purpose: The keel is used following repair of stenosis or removal of the Montgomery Laryngeal Stent to help form a sharp anterior commissure and prevent stenosis.
- Material: It is typically made of silicone rubber, which is inert and ensures re-epithelialization of incised tissue.
- Design: The keel consists of a flexible extralaryngeal portion and a flexible keel portion that extends through the anterior commissure.
- Function: The extralaryngeal portion covers the thyrotomy repair and is sutured to the thyroid laminae, while the keel portion helps maintain the sharpness of the anterior commissure.
- Safety: The device is MRI safe and does not contain natural rubber latex.
- Usage: It is intended for single-use and requires a prescription.
- Manufacturer: The Laryngeal Umbrella Keel is manufactured by E. Benson Hood Laboratories.
- Regulation: The device has an FDA premarket submission number of K841348 and is classified under the FDA product code FWN, which stands for Prosthesis, Larynx.
- Availability: It is commercially available and distributed by E. Benson Hood Laboratories.
- Clinical Use: The keel is beneficial in preventing the recurrence of anterior glottic stenosis after surgical correction, ensuring a more complete closure of the anterior commissure to minimize laryngeal secretions into the extralaryngeal spaces.