Description

The Blom-Singer® Nasal Septal Perforation Prosthesis Oval is an innovative medical device designed for the non-surgical closure of nasal septal perforations. This specialized prosthesis is intended for use by healthcare professionals and offers a versatile solution with its availability in various oval shapes, sizes, and thicknesses.

Design and Functionality

• Two-Piece Magnetic Coupling: The device features a two-piece, magnetically coupled design that ensures secure attachment while allowing for easy insertion and removal.
• Bi-Flanged Structure: Each prosthesis includes thin, overlapping flanges that extend beyond the perforation, providing effective closure and retention. These flanges can be trimmed by clinicians to achieve a custom fit.
• Material Composition: Constructed from medical grade silicone with fully enclosed neodymium magnets, the device is designed to minimize direct contact with sensitive tissues, reducing crusting and bleeding.

Benefits

• Symptom Management: By covering all tissue margins, the prosthesis helps alleviate symptoms such as nasal obstruction, whistling, and epistaxis without curing the underlying condition.
• Temporary or Long-Term Use: Suitable for both temporary and long-term application, the device does not interfere with potential future surgical interventions.

Indications and Contraindications

• Intended Use: Ideal for patients with symptomatic nasal septal perforations where surgical options are limited or contraindicated. Placement is typically performed under local anesthesia in a clinical setting.
• Contraindications: Not recommended for individuals with septal deformities, pacemakers, or during MRI procedures. Other contraindications include acute infections and certain medical conditions such as Wegener’s granulomatosis.

Available Sizes

The oval variant is offered in the following sizes:

• 11mm x 13mm (2mm and 3mm thickness)
• 13mm x 17mm (2mm and 3mm thickness)
• 15mm x 21mm (2mm and 3mm thickness)

Potential Complications

While generally effective, potential complications may include poor fit, discomfort, crusting, or nasal pain. Proper placement and post-care, such as saline irrigation and steam inhalation, are essential to minimize these risks.

Testing and Compliance

The prosthesis has undergone rigorous mechanical and biocompatibility testing, ensuring its reliability and safety. It is considered substantially equivalent to existing devices, aligning with relevant regulatory standards.

Designer

This device is expertly designed by Eric D. Blom, Ph.D., reflecting a commitment to addressing complex medical needs with precision and care.