Nasal Retainer
Product description and features
The Pharmacleft Nostril Retainer® is a silicone-based prosthesis placed into the nasal cavity, available in several sizes.
The Pharmacleft Nostril Retainer® has a unique design that guides the septum into a central position. Its patented shape is the result of extensive research and testing. It provides extra support at the critical points in order to guide the septum to the centre and to shape the nasal tip in the best possible way. The curve of the design follows the natural shape of the nostrils, which offers the highest comfort for the patient. The soft-touch silicone, combined with the unique shape of the Pharmacleft Nostril Retainer®, ensures optimal wearing comfort. The device has two tubes that are joined by a “connecting bridge” for safety.
Intended use
The Pharmacleft Nostril Retainer® is used to treat a deviated septum and/or the nostrils. It can be worn both before and after cleft lip and nasal surgery. Before surgery the device helps to correct deformities of the septum and/or the nostrils, bringing them into a more central shape. After surgery the Pharmacleft Nostril Retainer® serves to maintain the results of the corrective operation and to shape the nasal tip further.
Users
Infants, toddlers, children, adolescents and adults of any gender who have a unilateral or bilateral cleft lip and/or palate. Because of this condition the nasal tip is off-centre and one of the nostrils may be enlarged.
Before a possible rhinoplasty/septoplasty/septorhinoplasty (usually performed after puberty), the nostril retainer helps to create a more symmetrical, more natural nasal tip: by “guiding” the nose during growth, there is a greater chance that the nose will end up symmetrically in the centre. At the very least it helps to create a better starting point for nasal surgery. This is why most nostril retainers are used in young children: by the age of 4 a child's head has already reached 80% of its adult size. It is therefore assumed (although not yet scientifically proven) that the nostril retainer has the greatest effect in childhood.
Service life
It may be used continuously for a maximum of 30 days.
The physician determines the condition and the duration of the treatment.
The Pharmacleft Nostril Retainer should be used daily, with a recommended wearing time of at least 12 hours. After daily use the retainer must be cleaned before it is worn again, in order to ensure optimal hygiene.
Performance tests carried out
- Biocompatibility testing according to EN ISO 10993
- Sterilisation and disinfection testing after autoclaving, chlorhexidine and disinfectant alcohol
- Cleaning test
- Nasometry test (= airflow through the nose while speaking)
- UV stability test
- Testing of the effect of ambient temperature:
- Cold: the Pharmacleft Nostril Retainer was tested at -18°C for 6 months.
- Heat: the Pharmacleft Nostril Retainer was tested at 200°C for 1 hour.