Description

The Blom-Singer® Nasal Septal Perforation Prosthesis Oval is a specialized medical device designed for the non-surgical closure of nasal septal perforations. This innovative solution is particularly beneficial for patients who are not suitable candidates for surgical repair, or those with large, irregular, or posterior perforations.

Key Features

• Symptom Relief: Alleviates common symptoms associated with nasal septal perforations, such as nasal obstruction, crusting, dryness, pain, nosebleeds, whistling, and irritation.

• Magnetic Coupling: Comprises a two-piece design with neodymium magnets, allowing for secure and easy insertion, removal, and replacement.

• Medical-Grade Silicone: Crafted from high-quality, platinum-cured silicone, ensuring durability and biocompatibility. The soft, flexible material adapts seamlessly to septal curvatures and irregularities.

• Custom Fit: Available in both prefabricated and custom-made options. Custom versions are tailored using a mold of the patient’s perforation for precise fit and comfort.

Design Specifications

• Shape and Size: Offered in an oval shape with various sizes and thicknesses to accommodate different anatomical needs. Flanges extend beyond the perforation for secure retention and can be trimmed for a personalized fit.

• Stability: Designed to minimize movement, bleeding, and crusting, enhancing comfort and effectiveness. The center post and flanges reduce pistoning and side-to-side movement.

• Discreet Handling: Some models feature a handle for insertion and extraction, which remains hidden under the alar dome when in place.

Professional Use

This prosthesis is intended for use by qualified medical professionals in outpatient, clinical, or hospital settings. Certain models may allow for patient self-management, providing flexibility as a temporary or long-term solution.

Care and Maintenance

• Usage Duration: Suitable for use up to 29 days for some models, with recommended cleaning intervals based on clinical advice.

• Cleaning Instructions: Proper maintenance includes regular cleaning, with additional care such as saline irrigation, nasal cream, and steam inhalations as advised.

Contraindications

• Not recommended for individuals with septal deformities, pregnancy, pacemakers, or those undergoing MRI or radiation therapy.
• Should not be used in the presence of active nasal infections or actively bleeding perforations.

Performance and Safety

The Blom-Singer® Prosthesis is FDA-cleared, demonstrating substantial equivalence to predicate devices. It significantly reduces symptoms, improving quality of life with minimal risk of infection. Rare complications may include displacement, local irritation, or obstruction.

Additional Features

• Custom Coloring: Available for custom models to match nasal mucosa.
• Model Retention: All models and molds are retained for easy replacement, offering a reliable alternative to surgical intervention without precluding future surgical options.