ExEm Foam Kit

An inexpensive, simple, one kit solution for outpatient ultrasound testing of tubal patency in patients with fertility problems

The ExEm® Foam Kit enables easy recognition of tubal patency by using a new technique: Hysterosalpingo Foam Sonography (HyFoSy). The kit has been developed for creating a foam.

It provides an inexpensive, simple, one kit solution for outpatient ultrasound testing of tubal patency in patients with fertility problems. Achieving better results in HyCoSy procedures, the imaging is superior and longer lasting than any other sonohysterography products.

By mixing ExEm® gel and purified water a gel foam is created. After infusing the foam through the uterine cavity into the fallopian tubes, practical ultrasound images can be obtained to check the patency of the fallopian tubes in infertility patients. Subsequently high quality ultrasound images can be obtained.

Useful In Case of Infertility of After Sterilisation Procedure

Used In Combination With Ultrasound Imaging

Bright Visualisation of Contour of Fallopian Tubes / Uterine Cavity

Clinic Based Solution


  • Office based solution
  • Superior fill images
  • A bright visualisation of contour of fallopian tubes and uterine cavity
  • Used in combination with ultrasound imaging
  • Less need for radiology or laparoscopy
  • Simple to use
  • Safe
  • Reduced discomfort for patient
  • Perfect control over administration of gel foam
  • Excellent tubal transit
  • Value for money

ExEm gel consists of: hydroxyethylcellulose and glycerol.

The ExEm® Foam Kit consists of;

  • 1 x 10ml syringe with 5ml of ExEm® gel
  • 1 x 10ml syringe with 5ml ExEm® purified water
  • 1 x coupling device

De Smit Medical offer two catheter options for infusing the ExEm® Foam Kit:

GIS Catheter: (GISCATHN970)

For easier insertion and reduced patient discomfort.

The GIS catheter has been specifically developed to overcome some of the difficulties associated with traditional balloon catheters which on occasions may be difficult to insert and uncomfortable for the patient, particularly when the balloon is inflated.

The unique tip design incorporates graduated beads which adapt to the patients anatomy for comfortable placement and closure of the cervical canal, removing the need for full insertion beyond the internal OS. The GIS catheter should be inserted into the cervical canal (just past the external OS) until a resistance is felt, without causing discomfort for the patient.

Features:

  • No balloon
  • Non-Latex, single use
  • Soft tip for patient comfort
  • No need to fully insert the catheter into the uterus
  • The graduated beads on the tapered tip adapt to each patient
  • Catheter shaft is malleable for curving to the patients anatomy for easier insertion
  • Larger lumen aids infusion and improves control

Argon Balloon Catheter 7 French: (MANCATH)

For HSG and HyCoSy – Designed for ease of use and a more effective seal.

The ideal choice of balloon catheter for diagnostic procedures such as radiological Hysterosalpingo-Contrast-Sonography (HyCoSy). This HSG catheter has a soft, concentric, non-latex balloon which prevents leakage of the ExEm® Foam.

NB: we recommend the 7 french catheter for ease of infusion and greater control.

Features:

  • Non-latex, soft, concentric balloon
  • Open-ended, round distal tip is soft and short to minimise trauma to the cervical canal and uterine cavity
  • The distal end-hole design allows for even distribution of contrast media
  • The malleable introduction sheath retains curvature to facilitate easy placement into the cervical canal
  • Color-coded stopcocks on both catheter lumens
  • Fixed volume syringe prevents over-inflation of the balloon
  • Store in suitable room and at a temperature between +5°C and +25°C.
  • 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.
  • Typically, 2 years shelf life detailed on packaging, unopened.
Please contact de Smit Medical for all pricing information.
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.
At least 5 - 7 minutes (sealed syringe). The remaining solution may be remixed in the syringe to re-introduce the air bubbles.
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.
‘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
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.
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
Typically, approximately 2-3 ml. On occasions, more may be required.
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.
The GIS catheter (de Smit Medical) 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.
Preferably GISCATHNM970 catheter or the Argon balloon catheter supplied by de Smit Medical – 7 french recommended. NB: 5 french may be used but care should be taken as the reduced lumen may require a slightly greater force when infusing. Please refer to our Catheter section for more details.
In principle, none. HyFoSy is the HyCoSy procedure using the ExEm Foam.
No. ‘HyCoSy was 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.
Yes. Since its launch in 2010, over 16000 tubal patency tests (as @ Dec 2014) have been carried out in the UK and Ireland 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 safety data is available in the business case document, available in the Download tab on the ExEm Foam Kit product page.
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.
Yes - CE marked for Europe specifically for intra-uterine investigations.
Yes - For single use only. Do not reuse. 
No - It is a Class I Medical device.
The new ExEm Foam Kit FK05 now contains a 10ml syringe with 5ml of ExEm® gel, a 10ml syringe with 5ml ExEm purified water and a coupling device.
ExEm Foam consists of:
  • ExEm gel – hydroxyethyl cellulose & glycerol
  • Purified water
When mixed together, a foam of micro-air bubbles is formed.
  1. Dilute the 5 ml ExEm® gel with the 5 ml (purified) ExEm® 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.
  2. Leave the gel foam in one syringe and disconnect the other syringe and coupling device.
  3. Connect the syringe containing the gel foam to a suitable catheter and infuse the gel foam within approximately 5 minutes.
  4. Subsequently the Hysterosalpingo Sonography procedure can be executed. Attention: when
    executing the Hysterosalpingo Sonography procedure use at least a 7 French catheter.
    Storage conditions: the ExEm® Foam-kit shall be stored in a suitable room and at a temperature
    not exceeding +25°C.
  5. Transport conditions: During transport of the ExEm® Foam-kit a temperature in the tolerance
    range between +40°C and -10°C must be maintained. However, the Products may temporarily (no
    longer than one week) be exposed to temperatures up to +40°C and -20°C.
  6. Important notice: Farco-Pharma GmbH, the manufacturer of the 10 ml syringe with purified water,
    has extended the intended use of the purified water with “dilution of gels”.
    Patents pending: NL 2003660.
For all NHS & Corporate purchasing, please contact us on +44 (0)845 345 4226 or via our contact form.

Warnings:
The ExEm® Foam-kit should be considered as contaminated medical waste after use.
Do not use if package has been previously opened or damaged.
This device is intended for single use only. Any foam not used in one examination session must be discarded. Do not reuse, resterilize or autoclave. Reuse of single use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient. Cleaning, disinfection and sterilization may compromise essential material and design characteristics leading to device failure. The manufacturer will not be responsible for any direct incidental or consequential damages resulting from re-sterilization or reuse.

Reuse of this product can result in danger to the patient.
Do not use the ExEm® Foam-kit after expiry date of ExEm® gel, the ExEm® water, and/or the coupling device.

Do not use the ExEm® gel and the ExEm® water separately for Hysterosalpingo Sonography.
The ExEm® gel and the ExEm® water are not to be used for injections.

STERILE unless package has been opened or damaged.

FOR SINGLE USE ONLY. DO NOT REUSE.


Sterile: 

The ExEm® Foam Kit FK05 contains a 10ml syringe with 5ml of ExEm® gel, a 10ml syringe with 5ml ExEm® purified water and a coupling device.


Contraindications: 
• Do not use the foam during pregnancy.
• Do not use the foam if the patient is suspected to be pregnant/could be pregnant.
• Do not use the foam between ovulation and menstruation.
• Do not use the foam in the presence of active pelvic infection, sexually transmitted diseases and
profuse bleeding.
• Do not use the foam in case of allergy to any of the constituents of ExEm® gel
(hydroxyethylcellulose, glycerol and purified water).

Angela Clough, Sonographer, is available by email for your queries relating to:

  • Starting up a HyCoSy service
  • Ultrasound techniques for HyCoSy
  • Use of Exem Foam Kit
  • Catheter Choices etc

Angela is also available for a visit to your department to advise and assist with procedure and scanning techniques, by arrangement and quotation.

A highly experienced sonographer (DCR(R) DMU MSc) in the field of HyCoSy, practicing at Guys Hospital Assisted Conception Unit and Weston General Hospital, Angela is also an experienced lecturer in the field of gynaecological ultrasound.

You can contact Angela via our contact form.

Support Information

Helpdesk:
Head Office:
  • Address
    • de Smit Medical Systems Ltd, Unit 15 Falcons Gate, Dean Road, Bristol, BS37 5NH, UK
  • Operating Hours
    • Monday to Friday - 9am-5pm (Excluding bank holidays)
Service Centre:
  • See Head Office above
  • Please contact the Service Centre regarding any equipment servicing/repair related queries or telephone troubleshooting
Trained Personnel:
  • 7 x Sales technicians
  • 3 x Medical engineers at Head Office
    • All trained to manufacturer standard
Turnaround:
  • Warranty Repairs
    • 72 working hours response/resolver call-out for warranty repairs and service plans
  • Non-warranty Repairs
    • 72 hours subject to authorisation by Customer for paid repair
Spare Parts:
  • Spare parts for MCube/Datrend products are available direct from de Smit Medical Systems Ltd
  • Next working day delivery if order received by 2pm on any given working day (subject to availability)

We’ve started to use ExEm foam few weeks ago and were very impressed with quality of images we were getting and ease of use. We also noticed that ExEm foam does not give any discomfort for patients. Definitely would recommend to all my colleagues.

Dr.Lyuda ShkrobotPatient Coordination Manager EDE Programme Manager & Head of Ultrasound - Sims International Fertility Clinic, Dublin

We have tried the Ex Em Foam system and like the simplicity of mixing the contrast. It also gives us the option of examining the endometrial cavity with the same agent. The catheters are also extremely good as you do not have to pass anything through the cervix or inflate balloons. This speeds up the whole process and is much more comfortable for the patient.

Ken ReadSonographer - Bourn Hall Clinic, Colchester

ExEm Foam is a very simple yet effective contrast medium for an ultrasound based tubal patency testing. It is seen very clearly on ultrasound and is cheaper than the products I have used in the past. I will definitely be ordering and using it regularly from now on.

Dr Suruchi AroraAssociate Specialist in Maternity, with special interest in Gynaecological Scanning - The Royal Berkshire Hospital, Reading

In my opinion ExEm foam is quite simply the best contrast medium for HyCoSy to date (and in our unit we¹ve used just about every other over the last 10 years, with experience of over 1,500 procedures)

Stephen KillickRetired Professor of Reproductive Medicine and Surgery - University of Hull and Hull York Medical School

First Class Product, virtually pain-free, wouldn’t use anything else!

Dr Rehan SalimConsultant in Gynaecology - Centre for Reproductive & Genetic Health (CRGH), London, and University College London Hospitals

We performed the first HyFoSy this afternoon and were very impressed with the ease of use and clarity of picture. As we needed to report on her uterus as well, we started with a saline sonogram first, waited a few minutes for the cavity to empty then performed HyFoSy. We will certainly be ordering ExEm sets for HyFoSy in the future.

Dr Magdy A N AsaadConsultant in Obstetrics & Gynaecology, Clinical Director - London Fertility Centre, Harley Street

Guy’s Hospital Assisted Conception Unit and HyCoSy training courses run by Mr Yacoub Khalaf, have been using ExEm Foam Kit since 2013. The Foam Kit provides excellent image clarity and ease of use making it the product of choice for HyCoSy examinations at Guy’s. The product is well supported in the UK by de Smit Medical.

Angela CloughAdvanced Ultrasound Practitioner - Assisted Conception Unit, Guy’s Hospital, London

We use the ExEm Foam Kit for all our HyCoSy examinations as well as the HyCoSy training courses. With 20 years of HyCoSy experience, it is by far the best medium available, consistently providing reliable, top quality imaging in tubal patency testing.

Mr C Philip HarrisConsultant Gynaecologist, Clinical Lead - WWL Hewitt Fertility Partnership, Wrightington, Wigan & Leigh NHS Foundation Trust

HyCoSy Course – Wrightington Hospital – 22nd October 2019

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HyCoSy Venue – Guy’s Hospital

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HyCoSy Venue – King’s College Hospital

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