Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis
Designed by Eric D. Blom, Ph.D., the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is made from medical grade silicone and is designed to reduce leakage of saliva, food and drink around a Hypopharyngeal Fistula. The prostheses come in three sizes, 25mm, 38mm, and 50mm, ensuring a proper fit.
MANAGEMENT OF THE HYPOPHARYNGEAL FISTULA
- May maintain a dry fistula tract
- May reduce leakage of saliva, food and drink
- NPO Instructions may be alleviated
- May allow eating by mouth, possibly avoiding/reducing enteral/ parenteral nutrition
- Potential for post-laryngectomy speech with TEP
PROMOTES COST SAVINGS
- Insertion & Removal Catheter (I&R) provided
- Can be placed in-office or operating room (choice in anesthesia protocol/ necessity)
- Anesthesia and facility cost may be reduced
WHAT IS INCLUDED IN THE OFFERING?
- Insertion & Removal Catheter (I&R) provided with the 25mm and 38mm prosthesis
- The 50mm Adjustable Bi-Flanged Fistula Prosthesis does not require the (I&R) catheter
IS IT STERILE?
3-year shelf life from date of manufacture.
CAN THIS DEVICE BE REPROCESSED FOR MULTI-PATIENT USE?
No, single patient use only
The Blom-Singer® Fistula Prosthesis Placement & Function
- Soft, flexible
- Medical grade silicone
- Translucent to allow fistula tract visualization
- Medical grade silicone, radiopaque
- Elastomeric (stretchable)
- Locking loop prevents flange movement
The Blom-Singer® Fistula Prosthesis Insertion & Removal (I&R) Catheter
- Material: Semi-rigid thermoplastic polyurethane
- For insertion and removal with these sizes only, 25mm and 38mm prosthesis
- 8 Fr. catheter diameter gradually increasing to 11 Fr. in the keyhole end
- Designed for non-surgical insertion and removal of the fistula prostheses in the office or operating room
- Sterile , 3-year shelf life
- Single-use, disposable