Eradicate intrauterine adhesions once and for all

 
Adhesion Barrier Deployement
Intrauterine adhesion and asherman syndrome

About intrauterine adhesions

Intrauterine adhesions (IUA) or synechiae are fibrous strings at opposing walls of the uterus leading to partial or complete obliteration of the cavity. They may also be referred to as Asherman syndrome. They occur as the consequence of surgery in the uterine cavity and are the major long term complications of operative hysteroscopy. 

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They are responsible for menstrual disorders, infertility and obstetrical complications such as abnormal placentation. They are associated with miscarriages and retained product of conception with a reported incidence as high as 20% following dilation and curettage for those conditions (1, 2) and up to 45% after myomectomy (3,4). 

 

The recurrence rate after intrauterine adhesiolysis is between 42% and 60% in the case of severe adhesions (5). 

 

Surgical adhesions can be prevented by separating the adjacent injured tissues at the beginning of the scaring phase. While adhesion barrier products exist for abdominal or pelvic surgery like absorbable films or gels, none of them is adequate for intrauterine use, leaving women's uterus unprotected after an intervention.

Womed Leaf™

Intrauterine Adhesion Barrier Film

 
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Womed Leaf is the first and only MECHANICAL BARRIER against adhesions that protects the entire uterine cavity for a week.

Principle

Insertion

At the end of the surgical procedure, Womed Leaf is inserted through the cervix like an IUD and the uterine film is released.

adhesion barrier insertion
adhesion barrier deployment

Self deployment

It soaks uterine fluids and grows up to become a film that shields the entire cavity.

Mechanical barrier

By keeping the walls apart, Womed Leaf acts as a mechanical barrier during 1 week.

Mechanical adhesion barrier
Adhesion barrier self discharge

Self discharge

After a week, the uterine film breaks-up, dissolves and is naturally discharged without any intervention of a healthcare professional.

Intended use: Womed Leaf is intended for the prevention or reduction of new or recurrent intrauterine adhesions formation by creating a temporary mechanical barrier. 

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Indication: Womed Leaf is indicated for use in all transcervical procedures.

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Womed Leaf is a CE marked product.

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Not for sales in the US.

Why Womed Leaf?

See clinical evidence

Rapid insertion

At the end of the surgical procedure, Womed Leaf is inserted through the cervix with a flexible inserter, just like an IUD. The uterine film is not sticky and the insertion takes less than 1 minute.

No follow-up required

After a week, the uterine film breaks-up, dissolves and is naturally discharged through the cervix without any intervention of a healthcare professional.

Mechanical barrier

Womed Leaf anti adhesion film self deploys and keeps the uterine walls apart after an intrauterine procedure.

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Long lasting effect

Womed Leaf acts as a mechanical barrier during a week, the critical part of the healing phase.

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Full cavity protection

Thanks to its swelling ability when in contact with water, Womed Leaf grows to fill the entire uterine cavity.

Safe by design

Product composition and tolerance

Womed Leaf has been designed from well known highly biocompatible compounds: poly(D,L-lactide) acid (PLA) which is commonly used in medical devices like surgical sutures, and poly(ethylene oxide) (PEO) which is a common pharmaceutical excipient. Womed Leaf biocompatibility, tolerance and non toxicity has been thoroughly proven in preclinical studies (6).

Womed Leaf adhesion barrier
Womed Leaf fertility

Fertility

A pre-clinical study evaluating possible effects on fertility showed that Womed Leaf had no negative impact on the implantation and development of embryos (6).

Efficacy

Womed Leaf significantly reduces the likelihood of complete IUA formation compared to hyaluronic acid (HA) gel and sham group, demonstrating its efficacy in an animal model (6).

Womed Leaf efficacy

Interested in working with us?

Do you perform hysteroscopic surgeries and want to eradicate intrauterine adhesions once and for all? We will be happy to help.

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Womed Leaf is a CE marked product.

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References

  1. Salazar et al. A comprehensive review of Asherman’s syndrome: causes, symptoms and treatment options Curr Opin Obstet Gynecol 2017, 29:249–256

  2. Hooker et al. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome Human Reproduction Update, 2014;20(2)262–278

  3. Taskin et al. Role of endometrial suppression on the frequency of intrauterine adhesions after resectoscopic surgery. The Journal of the American Association of Gynecologic Laparoscopists 2000;7(3):351–4

  4. Guida et al. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Human Reproduction 2004;19(6):1461-64

  5. Warembourg S et al. Prevention and treatment of intrauterine synechiae : Review of literature. J Gynecol Obstet Biol Reprod. 2015 Apr ; 44 :366-79.

  6. Huberlant et al. In Vivo Evaluation of the Efficacy and Safety of a Novel Degradable Polymeric Film for the Prevention of Intrauterine Adhesions. JMIG. 2020