Description

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is an innovative medical device designed to manage hypopharyngeal fistulas effectively. Developed by Eric D. Blom, Ph.D., this prosthesis aims to reduce leakage of saliva, food, and drink around the fistula, helping maintain a dry tract. This functionality may facilitate oral feeding and enhance post-laryngectomy speech, potentially reducing the need for alternative nutritional methods.

Key Features

• Flange Design: The device features two soft, flexible, translucent flanges that allow for clear visualization of the fistula tract. These flanges are connected by a stretchable, elastomeric beaded stem, providing secure placement.

• Material Composition: Made from radiopaque medical grade silicone, the prosthesis is visible in imaging and includes a locking loop to prevent unwanted movement.

• Size Variability: Available in three sizes, it accommodates fistula diameters from approximately 6 to 25 mm and tissue thickness from 1.5 to 25 mm. The flange diameters range from 25 mm to 50 mm, ensuring a suitable fit for various clinical needs.

Insertion and Maintenance

• Insertion & Removal Catheter: The Small and Medium sizes come with a sterile, single-use, semi-rigid thermoplastic Insertion & Removal Catheter, facilitating non-surgical placement. This design may reduce the need for anesthesia and associated costs.

• Detachable Flange: The outer flange can be detached for regular cleaning, enhancing hygiene and device maintenance.

Usage and Longevity

• Single-Use Design: The prosthesis is intended for single-patient use and is disposable after up to 29 days of continuous use. It is non-cytotoxic, non-sensitizing, and non-irritating, ensuring compatibility with patient tissues.

• Shelf Life: The device offers a 3-year shelf life from the date of manufacture, providing flexibility in inventory management.

Regulatory Information

• Classification: Classified as a Class I ear, nose, and throat manual surgical instrument, the prosthesis holds FDA 510(k) clearance, affirming its safety and effectiveness for clinical use.

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis represents a significant advancement in the management of hypopharyngeal fistulas, offering healthcare providers a reliable and versatile tool to improve patient outcomes.