EXEM® FOAM

/EXEM® FOAM
EXEM® FOAM2018-10-03T18:21:27+00:00

ExEm® Foam.           “Primum non Nocere”

ExEm® Foam has been developed for ultrasound assessment of tubal patency. By mixing ExEm® gel and ExEm® water, a gel foam is created. ExEm® Foam can be infused through the cervix and the uterine cavity into the fallopian tubes and thus creating a perfect extension of the walls of the fallopian tubes. Utilizing our specially designed and patented catheter with cervical applicator enables a smooth infusion of the gel foam and better visualization of the contour of the tubes.

Hysterosalpingo-Foam Sonography (HyFoSy), using ExEm-gel for creating stable foam, was developed as an office procedure for tubal patency testing*. The technique was tested in a prospective laparoscopy-controlled study*. Hysterosalpingo Contrast Sonography (HyCoSy) is, compared to the Hysterosalpingography (HSG), a first-line investigation to diagnose female tubal subfertility. For tubal patency testing, HyFoSy with ExEm-gelfoam is performing better then HyCoSy with saline, in terms of accuracy*.

ExEm-gel is considered to be safe*, as the components are well known and have been used intravenously and in the abdominal cavity for other medical purposes. There are no known serious side effects*. In a randomized controlled trial HyFoSy turned out to be less painful than HSG*. Furthermore, there are signs that HyFoSy may improve women’s chances of pregnancy, although this has to be investigated in future studies further before rm conclusions can be drawn*.

We are proud today ExEm® Foam has been used in over 300.000 procedures world wide and is recognized as a unique player in the fertility market, offering gynecologists a tubal patency test at their office using Sonography.

ExEm® Foam can be ordered thru our distributors, they are listed at the distal end of this page.

Dedicated training and workshops are offered by several institutions in the United Kingdom, France, Austria and the Netherlands. For more info please contact the respective distributor of these countries.

*references are available in the ‘Literature and Studies’ section below.

ExEm® Foam – “Primum non Nocere” – First, do no harm. Exactly what ExEm® Foam does.

Before you decide for HSG, please check the benefits ExEm® Foam can bring

  • Tubal patency test using Ultrasound

  • Office based procedure

  • Highly echogenic foam – resulting in superior fill images

  • Gel foam is simple to use, easy to inject, enabling short and convenient procedures

  • Specificy and Selectivity: comparable to or better then HSG – minimizing the need for Radiation*

  • Reduced discomfort for patient – VAS pain score 50% less compared to HSG **

  • Perfect control over administration of gel foam, excellent tubal transit

  • Scientifically proven with multiple publications in renowned magazines

  • World wide 300.000 procedures performed – distributed in over 50 countries

  • 3 independent publications, involving 715 patients, reported an average of 40+% spontaneous pregnancies within 2-6 months after HyFoSy Procedure using ExEm Foam.

Interested and ready to receive more information? Please fill in this form.

Tubal patency test using ultra sound

❗️ExEm® Foam is not available or approved for use in the United States, neither is the content on this page applicable to the United States.

ExEm Foam 2D UltraSound Video

ExEm Foam 2D UltraSound Video

Exem foam ultrasound

ExEm Foam 3D image

Exem foam ultrasound

ExEm Foam 3D – image courtesy of Dr. C. Exacoustos
Department of Obstetrics and Gynecology, Università degli Studi di Roma, ‘Tor Vergata’, Rome, Italy

ADDITIONAL INFORMATION

ExEm® Foam Kit

ExEm® Foam Kit product and procedure presentation, ultrasound tubal patency test.

 

ExEm® Foam Kit product and procedure animation.

HyCoSy with ExEm® Foam, a female fertility sonographic examination.
(Spaarne ZKH. Haarlem 03-02-2011)
HyCoSy with ExEm® Foam, a female fertility sonographic examination.
(Spaarne ZKH. Haarlem 15-12-2010)

ExEm® Foam in Summary

ExEm® gel and special designed applicators originally were developed for a more stable filling of the uterine cavity, being a patient and doctors friendly alternative for Saline Infusion Sonography (SIS). [1] Gel Instillation Sonography (GIS) became the first choice diagnostic procedure for uterine anomalies and pathology of the uterine cavity. Hysterosalpingo-Foam Sonography (HyFoSy), using ExEm-gel for creating stable foam, was developed as an office procedure for tubal patency testing. [2,3] The technique was tested in a prospective laparoscopy-controlled study. [4] Hysterosalpingo Contrast Sonography (HyCoSy) is, compared to the Hysterosalpingografy (HSG), a first-line investigation to diagnose female tubal subfertility. [5,6] For tubal patency testing HyFoSy with ExEm® Foam is performing better then HyCoSy with saline in terms of accuracy. [7,8] ExEm-gel is considered to be safe, as the components are well known and have been used intravenously and in the abdominal cavity for other medical purposes. There are no known serious side effects. [9] In a randomised controlled trial HyFoSy turned out to be less painfull than HSG. [10] Furthermore, there are signs that HyFoSy may improve women’s chances of concieving spontaneously, although this has to be investigated in future studies further before firm conclusions can be drawn. [11-12]

References:

GIS and HyFoSy                                                                                                              
1. Exalto N, Stappers C, van Raamsdonk LAM, Emanuel MH. Gel instillation sonohysterography: first experience with a new technique. Fertil Steril 2007; 87: 152-155.

2. Emanuel MH, Exalto N. Hysterosalpingo-foam sonography (HyFoSy): a new technique to visualize tubal patency. Ultrasound Obstet Gynecol. 2011; 37: 497-499.

3. Emanuel MH, van Vliet M, Weber M, Exalto N. First experiences with hysterosalpingo-foam sonography (HyFoSy) for office tubal patency testing. Human Reprod 2012; 27: 114-117.

4. Van Schoubroeck D, Van den Bosch T, Meuleman Ch, Tomassetti C, D’Hooghe Th, Timmerman D. The use of a new gel foam for the evaluation of tubal patency. Gynecol Obstet Invest 2013; 75: 152-156 Tubal Patency testing.

5. Lim CP, Hasafa Z, Bhattacharya S, Mahesahwari A. Should a hysterosalpingogram be a first-line investigation to diagnose female tubal subfertility in the modern subfertility workup? Human Reprod 2011; 26: 967-971.

6. Luciano DE, Exacoustos C, Luciano AA. Contrast Ultrasonography for tubal patency. J Min Inv Gynecol 2014; 21:994-998.

7. Rajesh H, Lim SL, Yu SL. Hysterosalpingo-foam sonography: patient selection and perspectives. Int J Womens health. 2016; 9: 23-32.

8. Piccioni MG, Riganelli L, Filippi V, Fuggetta E, Colagiovanni V, Imperiale L, Caccetta J, Panici PB, Porpora MG. Sonohysterography: comparison of Foam and Saline. J Clin Ultrasound. 2017; 45: 67-71.

Safety and side effects

9. Exalto N, Stassen M, Emanuel MH. Safety aspects and side-effects of ExEm-gel and foam for uterine cavity distension and tubal patency testing. Reprod Biomed Online 2014; 29: 534-540.

10. Dreyer K, Out R, Hompes PGA, Mijatovic V. Hysterosalpingo-Foam Sonography (HyFoSy): a less painful procedure for tubal patency testing during fertility work-up compared to (serial) hysterosalpingography. A Randomised Controlled Trial. Fertil Steril 2014; 102: 821-825

Enhanced pregnancy rate

11. Exacoustos C, Tiberio F, Szabolcs B, Romeo V, Romanini E, Zupi E. Can tubal flushing with Hysterosalpingo-Foam Sonography (HyFoSy) media increase women’s chances of pregnancy? Virtual Poster in: J Min Inv Gynecol. 2015; 22: S238 (Pregnancy chance 6M after HyFoSy: prim. infert. 30% / sec. infert. 38%).

12. Van Schoubroeck D, Van den Bosch T, Van Tornout K, D’Hooge T, Timmerman D. Spontaneous conception after hysterosalpingo-foam sonography (HyFoSy). Ultrasound Obstet Gynecol 2015; 46; 51 (suppl. 1; OC24.01) (Nr of pregnancies – after 359 procedures – highest in HyFoSy cyclus and two cycli afterwards).

ExEm® Foam Kit – FAQ and Usertips

1. What is the ExEm Foam Kit made of?
ExEm Foam consists of:
ExEm gel – hydroxyethyl cellulose & glycerol.
Purified water.
When mixed together, a foam of micro-air bubbles is formed.

2. What does the ExEm Foam Kit consist of?
ExEm Foam Kit FK05 contains a 10ml syringe with 5ml of ExEm® gel, a 10ml syringe with 5ml ExEm purified water and includes a coupling device.

3. Is the ExEm Foam Kit a drug?
No. According to the European Medical Device Directive, ExEm Foam Kit is a CE marked, Class I Medical Device

This is valid in Europe and some countries in the Middle East, Africa, Asia, South America and Canada.

4. Is the ExEm Foam Kit a single use device?
Yes. For single use only. Do not reuse.

5. Is the ExEm Foam Kit licensed for my country?
Yes. CE marked for Europe specifically for intra-uterine investigations.

According to the European Medical Device Directive, ExEm Foam Kit is a CE marked, Class I Medical Device.

This is valid in Europe and some countries in the Middle East, Africa, Asia, South America and Canada.

6. How long has the ExEm Foam Kit been on the market?
ExEm Gel has been available as a component of the GIS Kit (intra-uterine scanning) since 2007 and as part of the ExEm Foam Kit (tubal patency testing) since its launch in March 2010.

7. Is the ExEm Foam Kit safe? Evidence?
Yes. Since its launch in 2010, over 250.000 patency tests have been carried out world wide with no reported adverse or allergic reactions. ‘The combination of glycerol, hydroxyethyl cellulose and purified water is considered to be safe for intrauterine application and tubal patency testing’
Niek Exalto, Mario Stassen, Mark Hans Emanuel. Safety aspects and side effects of ExEm gel and foam for uterine cavity distension and tubal patency testing. Reproductive Biomedicine Online 2014; http://dx.doi.org/10.1016/j.rbmo.2014.07.015
Further evidence and publications are available on our website. Click the link ‘literature and studies’.

More safety data is available upon request.

8. Is the HyCoSy procedure uncomfortable for the patient?
No. ‘HyCoSy is known as a well-tolerated examination with a very low rate of side effects and no late complications that required no atropine or anti-inflammatory drugs’
Luca Savelli, Paola Pollastri et al. Tolerability, side effects and complications of hysterosalpingo contrast Sonography (hycosy).Fertility and sterility 2009 October; Vol. 92, issue 4, pp. 1481-1486.

9. What is the difference between HyCoSy and HyFoSy?
In principle, there is none. HyFoSy is the HyCoSy procedure using the ExEm Foam, where Contrast is replaced by Foam.

10. What catheter should you use?
Preferably the GIS LN970 Nulli para catheter, which we offer next to the ExEm Foam Kit, but any transcervical catheter designed for intrauterine application can be used as long as the syringe fits to the catheter opening.

NB: a 5 French catheter may be used but care should be taken as the reduced lumen may require a slightly greater force when infusing.

11. What is the GIS catheter?
The GIS catheter has a tapered soft tip that is inserted gently into the external OS adapting to each individual patient. By removing the need to insert a balloon catheter fully into the uterus (or inflating a balloon catheter in the cervical canal) some of the discomfort experienced by some patients may be reduced.

12. How do you use the ExEm Foam Kit?
Dilute the 5 ml ExEm® gel with the 5 ml ExEm® purified water by mixing the fluids from one syringe through the coupling device into the other syringe (at least 10 times). This creates a gel foam. Leave the gel foam in one syringe and disconnect the other syringe and coupling device.
Connect the syringe containing the gel foam to a suitable catheter and infuse the gel foam within approximately 5 minutes.

13. How do you best perform the HyFoSy examination ?

Follow the Instructions for Use. You can find the IFU on our webpage, please click the link corresponding to your language.

14. User tips and tricks:

a) Inject some gel foam through catheter after introduction of catheter into cervix.  Gel foam will be visible immediately, confirming proper placement of catheter.

b) When checked, continue to add 2-3 ml of gel foam. Gel foam will be visible in uterine cavity and continues to flow through the tubes.

c) Rotation of the ultrasound transducer (from longitudinal plane to transversal plane) can visualize the movement of gel foam through fallopian tubes.

d) Tubal patency is proved by filling of the tubes and/or by spreading of gel foam intra-abdominally. Gel Foam is absorbed in 48hrs.

e) ExEm Foam can be visualized with any 2D or 3D UltraSound equipment.

15. How much Gel foam will I use per examination?

Typically, approximately 2-3 ml. On occasions, more may be required.

16. Are there any contraindications?
ExEm Foam Kit: Do not use the gel foam in case of allergy to any of the constituents of ExEm gel (hydroxyethyl cellulose, glycerol and purified water).

Tubal patency test:  During pregnancy.
If the patient may be pregnant. Between ovulation and menstruation.

If the patient has co-morbidities. In the presence of active pelvic infection, sexually transmitted diseases and profuse bleeding.

17. Ultrasound scanning of the uterus;
a) Which should I do first, the tubal patency test or the uterine scan?
When conducting a combined diagnostic session, the intrauterine scan should always be conducted prior to the tubal patency test. The Uterine scan may highlight conditions that negate the need for the patency test – Hydrosalpinx.

b) Can I use the ExEm Gel on its own (without mixing with purified water) to scan the Uterus?
Yes. The ExEm Gel on its own is an excellent dilator and is will facilitate enhanced images due to its highly echogenic nature. Caution: due to the high viscosity of the ExEm Gel, a wait of at least 2 hours is recommended before then conducting a tubal patency test.

c) How long should I wait between the uterine scan and the patency test?
This will depend upon the contrast solution used for the uterine scan.  No contrast: immediately.

Saline – wait for a few minutes for the cavity to empty (remove the catheter).

ExEm Gel – min 2 hours.

18. When should I perform the patency test?
‘Tests of tubal patency are usually performed during the follicular phase of the cycle after menstruation has ceased’
The Fallopian Tube in Infertility and IVF Practice, chapter on Fallopian Tube Patency Testing – Stephen R. Killick: Cambridge Medicine

19. What should I do in the event of tubal spasm?
Wait a few minutes for the spasm to stop and then continue scanning. It should not be necessary to infuse more foam unless echogenicity has been lot.

20. How long do the microbubbles stay as a foam?
At least 7 minutes (sealed syringe). The remaining solution may be remixed in the syringe to re-introduce the air bubbles.

21. How long do you have visualisation once the foam has been infused?
Once the required amount of the foam has been infused (2 – 3 ml) echogenicity should be maintained for approximately 7 minutes. If the test is prolonged, it may be necessary to infuse more of the Foam.

22. Storage requirements
Store in suitable room and at a temperature between +5°C and +25°C.

23.Temperature tresholds

During transport of the ExEm Foam Kit, a temperature in the tolerance range between +5°C and +25°C must be maintained. However, the products may temporarily (no longer than one week) be exposed to temperatures up to +40°C.

24. Shelf life

Typically, 4 years of shelf life, detailed on the label which is attached to the packaging, unopened.

25. For any remaining questions, please contact info@iq-medicalventures.com.transurl.nl

Instructions for Use | ExEm Foam Kit

Please click on the link below to read the instructions for use in your language, all PDF files can be downloaded.

Please note : The figures of the instructions for use are under “General Info”. These should be combined with the instructions for use in your language.

ℹ️ General Info

🇬🇧 English          🇳🇱 Nederlands       🇵🇱 Polskie

🇩🇪 Deutsch         🇩🇰 Dansk                🇸🇰 Slovensky

🇫🇷 Français        🇸🇪 Svenska             🇬🇷 Ελληνικά

🇪🇸 Espanol         🇫🇮 Suomalainen    🇷🇴 Românesc

🇮🇹 Italiano         🇳🇴 Norsk                 🇭🇷 Hrvatski

🇵🇹 Português     🇭🇺 Magyar              🇨🇿 Česky

🇹🇷 Türkçe          🇪🇪 Eesti                   🇱🇹 Lithuania

🇱🇻 Latviešu

IQ Medical Ventures is an ISO 13485 certified company.

Click here for our certificate.

Click here for the congresses ExEm Foam will be exhibited.

Click here to visit our workshops.

DISTRIBUTORS EXEM® FOAM

Austria Bio-Koreska www.biokoreska.at
Australia Gytech Pty Ltd www.gytech.com.au
Belarus AlenMed www.alenmed.com
Belgium Luxembourg GOODLIFE Pharma SA/NV www.goodlifepharma.be
Benin Burkina Fasso Niger Ghana Ivory coast Togo GOODLIFE Pharma SA/NV www.goodlifepharma.be
Bulgaria Novus www.novus.bg
Cambodia MeetHeng www.meetheng.com
Canada Idoman www.idomansolutions.com
Chili International Medical Products IMP Chile www.impchile.cl
Croatia Medical Intertrade d.o.o. www.medical-intertrade.hr
Czech Republic Pentagen www.pentagen.cz
Denmark NordicCell ApS www.nordiccell.com
Estonia NordicCell ApS www.nordiccell.com
Finland NordicCell ApS www.nordiccell.com
France GOODLIFE Pharma SA/NV www.goodlifepharma.fr
Georgia Linori Ltd www.linori.com
Germany DiKaTec Medizintechnik GmbH & Co. www.dikatec-medizintechnik.de
Greece (Cyprus) SuppleKey www.supplekey.gr
Hungary FertiCad www.ferticad.hu
Iceland NordicCell ApS www.nordiccell.com
India DSS Imagetech pvt ltd www.dssimage.com
Ireland de Smit Medical Systems Limited www.desmitmedical.com
Israel Medlife www.medlife.co.il
Italy Cremascoli & Iris Srl www.cremascolieiris.it
Jamaica Harmon Medical Distributors www.harmonmedical.com
Japan IMMC International Medical Management www.imm-c.com
Kenia Pulse Healthcare www.pulsehealthcarekenia.com
Korea WoonamPharm www.woonampharm.co.kr
Kingdom of Saudi Arabia Treatment Ocean www.treatment-ocean.com
Kuwait Mesca Company W.L.L. www.mescacompany.com
Latvia ViaMedPharma www.viamedpharma.lt
Lebanon IbraHadad www.ibrahadad.com
Lithuania ViaMedPharma www.viamedpharma.lt
Malaysia Dr.Sukhilmi www.drsukhilmi.com
Mauritius IQ Medical Ventures IQ Medical Ventures
Netherlands IQ Medical Ventures IQ Medical Ventures
New Zealand Gytech Pty Ltd www.gytech.com.au
Norway NordicCell ApS www.nordiccell.com
Oman Emirates & World Medical Supplies Emirates & World Medical Supplies
Paraguay PROGYNEC S.A. www.progynec.com
Phillipines i-Care Biotechnology Inc iCare Biotechnology
Poland Rovers Polska Sp. z o.o. www.rovers.pl
Portugal SPECULUM Artigos Médicos Lda. www.speculum.pt
Qatar Neplax Medical www.neplaxmedical.com
Romania Pondera Medical (Mediq) www.ponderamedical.ro
Serbia Sineks Medical www.sineksmedical.com
Singapore Neuvital Pte Ltd www.neuvital.com
Slovakia Pentagen www.pentagen.cz
Slovenia Medip d.o.o. www.medip.si
South Africa Medi Challenge www.medichallenge.co.za
Spain Dibimed www.kitazato-dibimed.com
Sweden NordicCell ApS www.nordiccell.com
Switzerland HYGIS SA www.hygis.ch
Taiwan Everclear Technology Inc www.evercleartech.tw
Thailand MeetHeng www.meetheng.com
Turkey  (Cyprus) Seres Ilac www.seresilac.com.tr
United Arabic Emirates Emirates & World Medical Supplies Emirates & World Medical Supplies
UK (incl. Ireland) de Smit Medical Systems Limited www.desmitmedical.com
VietNam Asso Pharma www.assopharma.com