Clinical Studies - Stryker ClariFix Instrucciones De Uso

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ClariFix Instructions For Use
NOTE: To ensure good contact with the target tissue and optimum treatment, avoid moving the
cryoprobe during treatment.
NOTE: To avoid unwanted tissue injury, always allow the balloon to thaw prior to removing it
from the target tissue, as indicated visually by ice melting from the balloon and target tissue.
Minimal to no resistance should be felt when removing the balloon from the tissue.
6. Once the flow of nitrous oxide has been stopped, ice crystals on the balloon will melt. It is
generally safe to move the cryoprobe away from the target tissue, as indicated by no adherence
of the balloon to tissue. In the event resistance is felt, wait for at least 30 seconds and try again.
7. Remove the balloon from the target tissue.
8. If a second treatment is desired, re-treat the target tissue or nearby area after the tissue is
thawed, approximately 2 minutes after the first application.
NOTE: Tissue may freeze faster during the second treatment if the tissue is still cold. The "freeze-
thaw-freeze" technique may be desirable for maximum destruction of the target tissue.
9. Once the cryogen canister is empty, it can be replaced following the directions below.
Canister Replacement
1. To remove a canister, hold the cryoprobe with the cryogen canister
pointing up and the exhaust port pointing away from the user and patient.
Grasp the handle of the cryoprobe with one hand and use the other hand
to loosen the top of the cryogen canister. Do not cover the exhaust ports
at the bottom of the cryoprobe handle to allow for optimal venting. Do not
depress the valve on/off button as you remove the cryogen canister.
NOTE: If using ClariFix in a sterile field with one of the provided sterile
caps, grasp the sterile cap to loosen, and replace the non-sterile cryogen
canister.
2. Loosening the cryogen canister will exhaust excess nitrous oxide.
3. Unscrew and remove the empty cryogen canister from the cryoprobe
and discard.
4. If desired, load a new cryogen canister into the handle, turning to ensure
the threads are fully tightened. Do not overtighten. When loading the
cryogen canister in a sterile field, use the additional sterile cap to grasp
the non-sterile cryogen canister. Refer to Figure 3.
Disposal
1. At the completion of the treatment, dispose of the ClariFix cryoprobe, caps, and all empty
canisters according to federal, state, or local regulations, and appropriate environmental health
safety guidelines for standard medical waste. Medical waste should be considered infectious
and requires special management/treatment.
WARNING: Do not discard pressurized cryogen canisters. Disposing of pressurized cryogen
canisters could injure personnel if the canister is not emptied prior to incineration or other
disposal methods. The cryogen canisters can explode at temperatures above 50° C (122° F).
NOTE: In accordance with the European REACH regulation and other environmental regulatory
requirements, the ClariFix device contains internal brass components with lead.
INCIDENT REPORTING
Any serious incident that has occurred in relation to the device should be reported to Entellus Medical
by calling Customer Service at (866) 620-7615. If dialing outside the United States, precede the
number with your country's exit code and the US country code (+1). EU Member States should also
notify the competent authority of the Member State in which the incident occurred.

CLINICAL STUDIES

A prospective, multicenter clinical study was performed at 3 sites in the United States to evaluate the
feasibility of cryoablation in the nasal cavity, using the ClariFix device, in adults with chronic rhinitis.
Twenty seven participants with chronic allergic or nonallergic rhinitis were treated bilaterally with the
ClariFix device (n=54 treatments) using local anesthesia. Participants were followed at 7, 30, 90, 180
and 365 days after treatment. Cryosurgery was well-tolerated and participants reported an average
pain rating of 1.19 on the Wong-Baker FACES pain scale (0=minimum score, 5=maximum score).
The primary efficacy outcome was the change in reflective Total Nasal Symptom Score (rTNSS) and
Visual Analog Scale (VAS). Nasal symptoms scores were significantly improved at all follow-up time
points through the 365-day follow-up. The mean rTNSS score was 6.2 ± 0.5 (scale of 0 to 12) at
baseline and was decreased to 4.3 ± 0.4 (n=27, p<0.005) at 7 days, 2.6 ± 0.3 (n=27, p<0.001) at 30
days, 2.7 ± 0.4 (n=27, p<0.001) at 90 days, 2.3 ± 0.5 (n=21, p<0.001) at 180 days, and 1.9 ± 0.3
5
Figure 6:
Cryogen canister
removal and/or
replacement