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blom-singer r tracheoesophageal fistula stent
Helix Medical
Summary: The Blom-Singer R Tracheoesophageal Fistula Stent is a medical device used to manage tracheoesophageal fistulas. It is primarily used by otolaryngologists and thoracic surgeons to maintain patency and support healing.
FDA Clearance Information
Pathway
510K
Number
K902112 ↗
Decision Date
August 1, 1990
Product Code
EWL
Device Class
Class 2
Evidence
0 studies
The Blom-Singer R Tracheoesophageal Fistula Stent was cleared through the FDA 510k pathway on August 1, 1990. Manufactured by Helix Medical, it is classified as a Class 2 device under product code EWL.
What It Is
The Blom-Singer R Tracheoesophageal Fistula Stent is designed to be inserted into a tracheoesophageal fistula to maintain patency and facilitate healing. It is typically made of biocompatible materials that provide structural support to the fistula tract. This stent helps prevent the closure of the fistula, allowing for proper aerodigestive function and reducing the risk of aspiration.
Clinical Applications
This stent is commonly used in patients with tracheoesophageal fistulas, often resulting from surgical procedures, trauma, or malignancy. It is frequently utilized in otolaryngology and thoracic surgery settings. The device is particularly beneficial for patients who have undergone laryngectomy or other head and neck surgeries, providing a stable airway and assisting in voice rehabilitation.
Indications for Use
The FDA indications for the Blom-Singer R Tracheoesophageal Fistula Stent include maintaining the patency of tracheoesophageal fistulas. It is indicated for patients who require support for fistula healing or prevention of closure, often following surgical interventions or in cases of congenital or acquired fistulas.
Practical Considerations
Clinicians should consider the appropriate sizing of the stent to match the patient's anatomy. Compatibility with other devices, such as voice prostheses, should be assessed. Proper technique during insertion is crucial to avoid complications such as migration or tissue irritation.
Frequently Asked Questions
What is the Blom-Singer R Tracheoesophageal Fistula Stent used for?
It is used to maintain the patency of tracheoesophageal fistulas, supporting healing and preventing closure.
What specialties typically use this device?
Otolaryngologists and thoracic surgeons commonly use this device in clinical practice.
What are the FDA-cleared indications?
The stent is indicated for maintaining the patency of tracheoesophageal fistulas, often following surgery or in cases of congenital or acquired fistulas.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.