Description

The Blom-Singer Advantage Indwelling Voice Prosthesis, developed by InHealth Technologies, is a specialized medical device designed for individuals who have undergone a total laryngectomy. This prosthesis plays a crucial role in voice rehabilitation through tracheoesophageal puncture (TEP), offering a reliable solution for those requiring secondary or replacement TEP procedures.

Key Features

• Clinician-Managed: This device is intended for insertion and replacement exclusively by a speech pathologist or physician, making it ideal for patients who cannot manage a removable voice prosthesis.

• Innovative Valve Design: The prosthesis features a one-way silicone valve embedded with silver oxide, which serves as a material preservative. This unique design may reduce or eliminate the need for anti-fungal agents for some users.

• Secure Placement: Equipped with an easy-fold esophageal retention flange and a flange introducer, the device ensures secure and effective placement.

• Atraumatic Insertion: Utilizes the Blom-Singer Gel Cap Insertion System for smooth and atraumatic insertion.

Cleaning and Maintenance

The device comes with a Brush and Flush Cleaning System, complete with built-in safety features, to be managed by clinicians. This system ensures proper maintenance and longevity of the prosthesis, with comprehensive support and training provided by healthcare professionals.

Specifications

• Valve Assembly Types: Available in HARD VALVE (20 Fr) and SOFT VALVE (16 Fr) assemblies.
• Size Options: Diameters of 16 French (Fr) and 20 French (Fr), with lengths ranging from 4 mm to 22 mm.
• Sterility Options: Offered in both non-sterile and sterile packaging.

Package Contents

Each package includes:

• The voice prosthesis
• A Secondary Placement Kit (inserter, flange introducer, gel caps, and lubricant)
• Cleaning accessories

Clinical Insights

As the first voice prosthesis to incorporate a valve with silver oxide, it is designed to reduce maintenance needs compared to non-indwelling types. The device typically lasts longer, with a reported mean lifespan of approximately 97 days. Common reasons for replacement include leakage, valve obstruction, or biofilm growth.

Intended Use

This prosthesis is not intended for patient self-insertion or removal, emphasizing the need for professional management. Its availability in multiple sizes and valve types allows for customization to fit patient anatomy and clinical requirements, providing a tailored solution for effective voice restoration.