REF EL-ADHME  (hystérométrie = 5-7 cm)

Destination:

Womed Leaf est destiné à prévenir ou à réduire la formation d'adhérences
intra-utérines, nouvelles ou récurrentes, en créant une barrière mécanique
temporaire.

Indication:

Womed Leaf est indiqué pour une utilisation dans les procédures
transcervicales (chirurgie hystéroscopique, aspiration et curetage)

Utilisation: Womed Leaf est un dispositif médical destiné à être utilisé par un 
professionnel de santé formé en obstétrique et en gynécologie.

Contre-indication: Hypersensibilité connue à Womed Leaf ou à l’un de ses composants.
Le dispositif ne doit pas être utilisé chez les patientes présentant une infection
ou une contamination du site chirurgical.

Emballage Quantité: 1 dispositif par boîte.

Dimensions: 340 mm x 76 mm x 15 mm

Stockage: Une fois réceptionné conserver le produit au frigo entre +2°C et +8°C

Un indicateur de température bleu est placé sur la boîte d’emballage. Vérifier
que le carré intérieur de l'indicateur de température est blanc ou gris clair.
L'indicateur de température vire au noir à 40°C: Si le
carré intérieur de l’indicateur est noir, le dispositif ne doit pas être utilisé.

Publications: Womed Leaf a été évalué dans plusieurs études précliniques et cliniques:
1- A new bioabsorbable polymer film to prevent peritoneal adhesions
validated in a post-surgical animal model - Allègre et al. (2018)
2- Preliminary design of a new degradable medical device to prevent the
formation and recurrence of IUA - Leprince et al. (2019)
3- In vivo evaluation of the efficacy and safety of a novel degradable polymeric
film for the prevention of intrauterine adhesions - JMIG - Huberlant et al.
(2020)
4- Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion
Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial - JMIG -
Weyers et al. (2021)
5- Hysteroscopic and ultrasound evaluation of a novel degradable polymer
film for the prevention of intrauterine adhesion formation after hysteroscopic
surgery - EJOG - Zizolfi et al. (2022)
6- First Use of a Novel Barrier Film in an Infertile Woman with Severe
Asherman Syndrome - JMIG - Sroussi et al. (2022)

_________________________________________________________________________

REF EL-ADHME  (uterine depth = 5 - 7 cm)

Intended use: Womed Leaf is intended for the prévention or reduction of new or recurrent
intrauterine adhesions formation by creating a temporary mechanical barrier.
Indication: Womed Leaf is indicated for use for women undergoing transcervical procedures (hysteroscopic surgery, D&C).

How to use Womed Leaf is intended to be used by healthcare professionals trained in

obstetrics and gynecology.

Contraindication: Known hypersensitivity to Womed Leaf or any of its components.

The devices must not be used in patients with infection or contamination of
the procedure site.

Packaging Quantity: 1 device per box.

Dimensions: 340 mm x 76 mm x 15 mm

Storage: Keep refrigerated below 8°C after receipt

There is a temperature indicator on the packaging box. Check on the
packaging box that the inner square of the blue temperature indicator is white
or light grey. The temperature indicator becomes black above 40°C, see image
below. Do not use the product if the inner square is black.

Publications: Womed Leaf was evaluated in several pre-clinical and clinical studies:
1- A new bioabsorbable polymer film to prevent peritoneal adhesions
validated in a post-surgical animal model - Allègre et al. (2018)
2- Preliminary design of a new degradable medical device to prevent the
formation and recurrence of IUA - Leprince et al. (2019)
3- In vivo evaluation of the efficacy and safety of a novel degradable polymeric
film for the prevention of intrauterine adhesions - JMIG - Huberlant et al.
(2020)
4- Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion
Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial - JMIG -
Weyers et al. (2021)
5- Hysteroscopic and ultrasound evaluation of a novel degradable polymer
film for the prevention of intrauterine adhesion formation after hysteroscopic
surgery - EJOG - Zizolfi et al. (2022)
6- First Use of a Novel Barrier Film in an Infertile Woman with Severe
Asherman Syndrome - JMIG - Sroussi et al. (2022)