Description

The Montgomery Thyroplasty Implant Male is a specialized medical device crafted from implant-grade silicone, designed specifically for medialization thyroplasty in male patients. This implant addresses unilateral vocal cord paralysis by medializing the paralyzed vocal fold, thereby enhancing voice quality and potentially improving swallowing function.

Design Features

• Rectangular Base: Constructed from firm silicone, the base features a three-tier design to ensure stability and prevent displacement.
• Triangular Top: Made from soft silicone, this component is tailored to align with the vocal cord, providing precise medialization.

The implant's self-retaining nature eliminates the need for suturing, and its radiopaque property allows for visibility in radiographic imaging. Each implant is preformed, molded, and supplied in sterile packaging, ensuring consistent sizing and a smooth finish.

Size Options

Available in sizes ranging from 8 mm to 13 mm, the implant is marked with size and gender for easy identification. Packaging options include individual implants, a 16-implant set, and comprehensive procedure kits that include surgical instruments and measuring devices.

Surgical Integration

The implant system includes custom surgical instruments and disposable measuring devices to facilitate accurate placement and sizing. The procedure involves creating a thyroplasty window in the thyroid cartilage, with the implant design and measuring system aimed at reducing surgery time and trauma.

Regulatory and Clinical Information

The Montgomery Thyroplasty Implant Male is FDA-cleared and classified as a Class II device. Clinical studies have demonstrated its safety and effectiveness in improving voice quality for patients with unilateral vocal fold paralysis.

Instructions for Use

Comprehensive instructions and a surgeon’s guide are provided to ensure proper use and optimal outcomes. This device represents a significant advancement in the treatment of vocal cord paralysis, offering a reliable and reversible solution for affected patients.