Description
The Blom-Singer® Nasal Septal Perforation Prosthesis Oval is an innovative 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 whistling, particularly for those who are not candidates for surgical repair or general anesthesia.
Design and Functionality
Crafted with precision, this device features a two-piece, magnetically coupled design that ensures secure attachment within the nasal septum. The bi-flanged, elastomeric structure comprises two flat flanges connected by a central post, allowing for a customizable fit. Clinicians can trim the flanges to accommodate individual anatomical needs, providing comfort and effectiveness.
Available in various oval shapes and sizes, the prosthesis includes neodymium magnets for easy insertion, removal, and cleaning. This design minimizes movement, bleeding, and crusting, making it a practical choice for both temporary and long-term use. Placement can be performed under local anesthesia in office or clinical settings, offering flexibility and convenience.
Material and Customization
Manufactured from medical-grade silicone and polycarbonate magnets, the prosthesis is available in standard sizes with options for custom fitting larger or irregular perforations. Advanced techniques such as CT imaging or alginate molds may be employed to achieve an optimal fit. The device is intended for single use, with a recommended duration of up to 29 days.
Professional Placement and Care
Qualified medical professionals place the prosthesis in hospital, outpatient, or clinical environments. Various insertion techniques are available, including purse-string suture and direct insertion with rotation. Post-placement care involves regular saline irrigation, nasal cream application, and steam inhalations to maintain hygiene and comfort.
Contraindications and Considerations
The use of this prosthesis is contraindicated in cases of septal deformities, pregnancy, presence of pacemakers, active nasal infections, and during MRI or radiation therapy. Patients with raw or actively bleeding perforations, acute infections, or specific medical conditions should also avoid use.
Performance and Safety
The device has undergone rigorous testing for sterility, biocompatibility, and cleaning validation. While generally well-tolerated, potential complications include displacement, epistaxis, crusting, and foreign body sensation. Regular cleaning and ongoing humidification are recommended to enhance performance and reduce risks.
Manufacturer Information
Developed by Inhealth Technologies under the Blom-Singer® product line, the prosthesis is designed by Eric D. Blom, Ph.D., and manufactured in the United States. It holds FDA regulatory status with product code LFB and is considered substantially equivalent to similar devices on the market.
This prosthesis represents a significant advancement in the management of nasal septal perforations, providing a tailored, effective solution for enhancing patient quality of life.
