Description

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is a specialized medical device designed for the effective management of hypopharyngeal fistulas. Developed by Eric D. Blom, Ph.D., this prosthesis aims to reduce leakage of saliva, food, and drink around a fistula, potentially maintaining a dry fistula tract. This can facilitate oral feeding and swallowing, and may support post-laryngectomy speech with tracheoesophageal puncture (TEP).

Key Features

• Bi-Flanged Design: The prosthesis features two soft, flexible, translucent flanges that allow for clear visualization of the fistula tract during placement.
• Material: Constructed from radiopaque, stretchable medical grade silicone, the beaded stem includes a locking loop to prevent flange movement.
• Size Options: Available in three sizes—25mm, 38mm, and 50mm—each offering specific flange overlap for secure fitting.

Usage and Placement

• Single-Use, Sterile Device: Each prosthesis is supplied sterile and intended for single use, with a 3-year shelf life from the date of manufacture.
• Insertion & Removal (I&R) Catheter: The 25mm and 38mm sizes come with a sterile, single-use I&R Catheter made of semi-rigid thermoplastic, facilitating trans-fistula insertion. The 50mm size does not require this catheter.
• Placement: Can be performed in-office or in an operating room by a trained physician, potentially reducing anesthesia and facility costs.

Regulatory Information

• Classification: Classified as an ear, nose, and throat manual surgical instrument under 21 CFR 874.4420, Class I, Product Code LRC.
• Prescription Use: Restricted to sale by or on the order of a physician (Rx only).

Clinical Insights

Clinical experience indicates that the prosthesis has helped control or eliminate salivary leakage in most patients and reduced fistula size in some cases, with no serious adverse events reported. This makes it a reliable option for short-term use, with periodic replacement recommended.

Sterilization and Testing

• Sterilization: Achieved through gamma radiation with a validated dose of 25 kGy.
• Testing: The device has passed biocompatibility and design verification testing, ensuring safety and effectiveness.

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis stands out as a well-engineered solution for healthcare professionals managing complex fistula cases, offering versatility and reliability in various clinical settings.