About Nasopore Nasopore® nasal dressing is made of a bio-degradable fragmentable foam. It is intended for use after nasal interventions (for instance sinusitis, polyposis and epistaxis). Nasopore® absorbs fluids, provides pressure to and supports the surrounding tissue. It prevents undesired adhesions.

Competitive advantages of Nasopore® Bio-resorbable: disappears within days Patient comfort: no traumatic removal Synthetic: 100% biologically safe Prevents adhesions Promotes mucosal regrowth Minimizes bleeding by controlled compression Aids to homeostasis Absorbs up to 25 times its weight Easy to use for surgeons Materials Nasopore® is a bio-degradable/ fragmentable, synthetic polyurethane foam produced by a freeze drying process. Strong polyurethane bonds provide excellent initial mechanical properties, whereas hydrophilic component facilitates water uptake and rapid fragmentation. The main material - soft segment - is based on lactide-caprolactone polymers.

Sizes and Density

Nasopore® is available in "Standard", "Firm" ("forte") and "Extra Firm"(forte plus") forms. Its sizes are 4 cm and 8 cm (rectangular form). Nasopore® "Standard" is used to prevent adhesions and to absorb fluids, whereas the Nasopore® "Firm" provides more pressure and is intended to provide extra mechanical support to damaged tissues. Nasopore® "Extra Firm" is denser than Nasopore® Firm and is applied when injured tissue (for example in case of nose correction surgery) needs extra support and haemostatic activity.

Classification

• European market
• Device class: Class-I, sterile
• EC Notified Body Identification number: 0344
• Notified body: KEMA
• US-market
• Device Class: 1 : 510(k) K052099
• Product Code: LYA
• Regulation Number: 21 CFR 874.4780
• Medical Specialty: Ear Nose & Throat
• Owner/Operator: POLYGANICS BV
• Owner/Operator Number: 9057333
• Establishment registration number: 3004504732