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.
- 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 patient’s 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
- ExEm Foam Kit - Business Case
- ExEm Foam Kit - Brochure / Information Sheet
- ExEm Foam Kit - Declaration of Conformity
- ExEm Foam Kit - Instructions For Use
- ExEm Foam Kit - Clinical Paper - Human Reproduction 2011
- ExEm Foam Kit - Clinical Paper - Leuven HyFoSy
- ExEm Foam Kit - Clinical Paper - Reproductive Biomedicine Online
- ExEm Foam Kit - Clinical Paper - A less painful procedure for tubal patency testing during fertility
- ExEm Foam Kit - Clinical Paper - Diagnostic accuracy of HyFoSy to confirm tubal occlusion after Essure® placement as treatment for hydrosalpinges
- 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.
- Do not use the gel foam in case of allergy to any of the constituents of ExEm gel (hydroxyethyl cellulose, glycerol and purified water)
- 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
- ExEm gel – hydroxyethyl cellulose & glycerol
- Purified water
- 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.
- 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.
- 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. - 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. - 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.
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).
Information 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
Request information via our contact form.
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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.
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.
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.
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)
First Class Product, virtually pain-free, wouldn’t use anything else!
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.
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.
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.
