Description

The Blom-Singer Advantage Indwelling Voice Prosthesis, crafted by InHealth Technologies, is a specialized device designed to aid voice rehabilitation for adults who have undergone a total laryngectomy. This prosthesis is intended for use in tracheoesophageal puncture (TEP) procedures, serving those who require secondary or replacement TEP interventions. It is particularly beneficial for patients who are unable or resistant to changing a removable voice prosthesis.

Professional Placement

• Clinician-placed: This device is inserted and replaced exclusively by a speech-language pathologist or physician, ensuring professional handling.
• Not for self-insertion: Patients are not intended to insert or remove the device themselves, emphasizing the need for professional management.

Innovative Features

• One-way Silicone Valve: Embedded with silver oxide, this valve acts as a material preservative, potentially reducing the need for anti-fungal agents.
• Esophageal Retention Flange: Features an easy-fold design for secure placement, complemented by a flange introducer for easier insertion.
• Gel Cap Insertion System: The Blom-Singer Gel Cap Insertion System ensures atraumatic insertion, enhancing patient comfort.

Maintenance and Cleaning

• Brush and Flush Cleaning System: Equipped with built-in safety features, this system facilitates regular maintenance.
• Healthcare Professional Maintenance: Cleaning and troubleshooting are managed by healthcare professionals, ensuring optimal device performance.

Size and Material Specifications

• Available Sizes: Diameters of 16 Fr. and 20 Fr., with lengths ranging from 4 mm to 22 mm.
• Material: Constructed from medical-grade silicone with silver oxide embedded in the valve.

Accessories

• Secondary Placement Kit: Includes an inserter, flange introducer, gel caps, and lubricant.
• Comprehensive Cleaning Tools: Ensures thorough maintenance and longevity of the device.

Device Lifespan

• Mean Device Life: Approximately 97 days, with a median life of about 67 days.
• Lifespan Variability: Influenced by factors such as leakage or biofilm growth.

Primary Function

The primary function of the Blom-Singer Advantage Indwelling Voice Prosthesis is to restore speech by allowing air passage from the trachea to the esophagus. This enables voice production while preventing food, fluids, and saliva from entering the windpipe. It is classified as a specialty indwelling prosthesis, with common device failures related to valve leakage, obstruction, or biofilm growth.

This prosthesis stands out as a vital tool for voice restoration, designed with precision and intended for exclusive use by healthcare professionals, ensuring a high standard of care for laryngectomy patients.