Description

The NASAL SEPTAL PERFORATION PROSTHESIS OVAL, part of the Blom-Singer® line, is a specialized medical device designed to address the challenges associated with nasal septal perforations. This prosthesis offers a non-surgical solution for patients experiencing symptoms such as epistaxis, breathing difficulties, and nasal discomfort, who are not suitable candidates for surgical repair.

Design and Features

• Magnetic Coupling: The device comprises two flanges connected by a center post, utilizing neodymium magnets for secure attachment. This design facilitates easy insertion, removal, and replacement, enhancing convenience for both patients and healthcare providers.
• Customizable Fit: Available in various oval shapes and sizes, the flanges can be trimmed by clinicians to ensure a precise fit, accommodating large or irregular perforations.
• Material Composition: Made from medical-grade silicone, the prosthesis is sterile and biocompatible, with magnets enclosed to prevent direct contact with nasal tissues.

Placement and Use

The prosthesis is intended for professional use, inserted by qualified medical personnel in outpatient, clinical, or hospital settings. It can be placed under local or general anesthesia and is designed for use up to 29 days per placement, depending on clinical protocols. The device serves as a temporary or long-term solution, without hindering potential future surgical interventions.

Performance Benefits

By providing a tight seal over the septal perforation, the prosthesis aims to alleviate symptoms such as bleeding, crusting, and nasal whistling. It reduces movement within the nasal cavity, potentially improving patient comfort and minimizing local irritation compared to other obturators.

Contraindications and Considerations

The use of this device is contraindicated in cases of septal deformities, pregnancy, presence of pacemakers, and during MRI or radiation therapy. Proper sizing and placement are crucial to minimize potential complications like displacement, crusting, and local irritation.

Care and Maintenance

Post-placement care may involve saline irrigation, nasal creams, and steam inhalations to maintain hygiene and device effectiveness. Periodic removal and replacement may be necessary based on patient needs and clinical assessments.

Manufacturer Information

Manufactured by Inhealth Technologies in the United States, this prescription-only device complies with regulatory standards, ensuring quality and performance. The Blom-Singer® Nasal Septal Perforation Prosthesis line is recognized for its innovative approach to managing nasal septal perforations, providing tailored solutions for improved patient outcomes.