Internal Nasal Bi-Valve Splint (Silicone)

An intranasal splint (INS) is a device made up of Silicone or Fluoroplastic that is placed on side of the septum with the intention of preventing adhesions, hematoma, and perforation, and to facilitate mucosal healing and support tissue alignment.

Design Benefit:

• Provides support the septum
• Prevents/reduces adhesions the septum and the lateral nasal walls.

Intended purpose:

The Internal Nasal Splints are made up of silicone or fluoroplastic and are designed to provide support to the Septum and reduce or prevent adhesions between the septum and the lateral nasal wall following nasal surgery.

Duration of Use:

Short-term use

Performance characteristics:

• Maintains the new shape and size until the fragile tissue heals (nose, nostrils, or septum).
• Offers protection if the nose accidentally gets bumped in the days after surgery.
• Reduces the Risk of adhesions and haematoma formation after surgery
• Achieves Nasal Alignment during healing

Clinical Indications:

Conditions for which Internal Nasal Splints are indicated include but are not limited to:

Nose surgery:

• Septoplasty
• Rhinoplasty
• Septorhinoplasty
• Nasal Fracture

Contraindications:

There are no known Contraindications.

Safety:

• Do not reuse: if the device is reused, it may cause harmful effect or infection to patient.
• Do not resterilize – if the device is resterilized, it may cause harm or infection to patient due to Resterilization of device.
• Do not use if the packaging has been opened or damaged.
• Internal Nasal Splints are short term Device. Internal Nasal Splints are to be sutured into place to prevent aspiration or movement.
• Care must be taken during disposal of device in order to avoid any risks of infection.
• For more information, please refer to the IFU.

Material : Medical-grade Silicone