Symbol Definitions - Stryker ClariFix Gebrauchsanweisung

®
ClariFix Instructions For Use
(n=15, p<0.001) at 365 days. Rhinorrhea and nasal congestion were the symptoms with the greatest
improvements. The average total VAS scores demonstrated a reduction from 7.6 at baseline to 5.5
at the 7 days (0=minimum score, 10=maximum score), with further reductions at longer follow-ups:
3.8 at 30 days, 3.6 at 90 days, 4.4 at 180 days, and 2.7 at 365 days (p<0.001 at all timepoints).
The primary safety endpoint was the frequency of device and procedure related serious adverse
events (SAEs). No device or procedure related SAEs were reported throughout the 90 day follow up
duration. The secondary safety endpoint was the frequency of device and procedure-related adverse
events (AEs). One participant reported moderate nasal bleeding at day 27 that was controlled with
standard nasal packing and cautery. The investigator deemed it to be remotely related to the device
as the target treatment location was completely healed during endoscopic examination at day 7.
Other adverse events commonly associated with healing after cryosurgery in the nasal passageways
(pain/discomfort, headache, facial pain, bleeding, dry nose and ear blockage) were observed and by
day 90, they had either self-resolved or the remaining events were rated as mild with a probable
cause relating to pre-existing conditions.
Another multicenter, prospective, nonrandomized, single-arm interventional clinical trial was
conducted at 6 centers in the US to assess the safety and effectiveness of the ClariFix device in
patients with chronic rhinitis (allergic and nonallergic). The primary efficacy endpoint was the change
from baseline to 90-day follow-up in rTNSS. The primary safety endpoint was the incidence of
treatment-related adverse events.
Ninety-eight participants underwent bilateral treatment with ClariFix in the office under local
anesthesia. The mean 90-day rTNSS score was significantly improved over baseline (6.1 ± 1.9 vs
3.0 ± 2.3, p<0.001) and remained improved through 9-month follow-up (3.0 ± 2.4, p<0.001).
One treatment-related serious adverse event was reported: a case of epistaxis that occurred 19 days
after treatment during retrieval of a pledget that had been inadvertently left in the nasal cavity on the
day of treatment. Bleeding was controlled with suction cautery in the operating room. Nonserious
adverse events included headache, sinus infections, epistaxis, eye dryness, and nasal synechia.

SYMBOL DEFINITIONS

Manufacturer
(ISO 15223-1, 5.1.1)
Date of Manufacture
(ISO 15223-1, 5.1.3)
Use-by Date
(ISO 15223-1, 5.1.4)
Batch Code
(ISO 15223-1, 5.1.5)
Catalogue Number
(ISO 15223-1, 5.1.6)
Non-sterile
(ISO 15223-1, 5.2.7)
Sterilized Using Irradiation
(ISO 15223-1, 5.2.4)
MR Unsafe
(Unsafe for Use in a Magnetic
Resonance Environment)
Sterile Barrier System
CE Marking of Conformity
Medical Device
Do Not Use if the Product Sterile
Barrier System or Its Package is
Compromised
(ISO 15223-1, 5.2.8)
Keep Dry
(ISO 15223-1, 5.3.4)
Upper Limit of Temperature 50° C
(ISO 15223-1,5.3.6 )
Consult Instructions for Use
(ISO 15223-1, )
Risk of Explosion
(ISO 7000, W002)
Do Not Re-use
(ISO 15223-1, 5.4.2)
Prescription Use Only
Caution
(ISO 15223-1, 5.4.4)
Quantity Per Box
Authorized Representative in the
European Community
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