Description

The Montgomery Thyroplasty Implant Male is a specialized medical device designed to enhance voice quality in patients with unilateral vocal cord paralysis. Manufactured by Boston Medical Products, Inc., this implant is intended for use in medialization thyroplasty procedures, providing improved glottic closure during phonation and swallowing.

Design and Material

Crafted from implant-grade silicone, the implant boasts a unique one-piece molded design that ensures biocompatibility and radiopacity. The structure comprises two main components:

• Rectangular Base: Made of firm silicone with a three-tiered structure to prevent displacement and rotation.
• Triangular Top: Made of soft silicone, designed to align with the vocal cord for effective medialization.

Each implant is marked with size and gender, with sizes available in 8 to 13 mm.

Features and Benefits

• Self-Retaining Design: Eliminates the need for suturing, making the procedure reversible and reducing surgical trauma.
• Standardization: Available in various sizes, each implant is supplied sterile, one per carton, ensuring ease of use and consistency.

System Integration

Part of the Montgomery Thyroplasty Implant System, it includes specialized surgical instruments and measuring devices for precise sizing and placement. The system can be accessed as individual implants, multi-implant dispenser sets, or comprehensive procedure kits.

Surgical Advantages

The implant simplifies the medialization laryngoplasty procedure by eliminating the need for hand-fashioning implants, thereby reducing surgery time and trauma. It is designed for prescription use only, with clinical data supporting its safety and effectiveness.

Regulatory Information

This FDA Class II medical device is 510(k) cleared, ensuring compliance with regulatory standards. It is intended for use by qualified medical professionals, with detailed instructions for use available through appropriate channels.

The Montgomery Thyroplasty Implant Male represents a significant advancement in surgical intervention for vocal cord paralysis, offering a reliable and effective solution for enhancing patient outcomes.