SHORT FACTS ABOUT TIES

• • TIES® is currently not suitable for colostomy or urostomy patients, only for ileostomy patients.
  • You cannot currently buy the TIES® product in any country. Those who currently have the TIES® technology are part of a clinical study.
  • We add new clinical centers to the clinical trial gradually, in different countries and cities.
  • Currently, clinical centers in the UK and India are actively recruiting patients to the clinical trial.
  • Patients in the clinical trial cannot have a Crohn’s disease diagnosis.
  • We follow each patient in the clinical trial for 52 weeks, so patients must live local to the clinical center.
  • We cannot release any results from the clinical trial until we have data after these 52 weeks.
  • We are expecting regulatory approval for TIES® in the EU (CE mark) in 2023 or 2024, to be followed by regulatory approvals in other markets.
  • There are currently no clinical trial centers in the US. We are planning to open a trial in the US and we have initiated this process. Unfortunately, we cannot say when this process will be completed.

QUESTIONS & ANSWERS

• Where can I find a doctor to discuss the TIES Solution?

  Click here to find your closest surgeon or hospital.

• What are the main advantages with using the TIES Solution?

  You will now be in control of the stoma, not the other way around!. Forget incessant thoughts of “where is the toilet?”.
  Forget the constant worrying about smell, noise, leaks, skin complications and bags coming off.

• Can all stoma patients use the TIES Solution?

  The TIES Solution is intended for adult patients with permanent ileostomy. Your doctor can advise you on any special considerations that might apply to you regarding the surgical procedure or use of the TIES Solution based on your medical history.

  Use for colostomy patients is under consideration for future development of the implant.

• Is it intended for new ileostomy patients or for existing ileostomies?

  The TIES Solution is suitable for patients with existing conventional ileostomies as well as for patients who are about to undergo surgery to create a permanent ileostomy.

• Is the surgical procedure complicated?

  In essence, the operation is the same as for a conventional ileostomy. The main difference is an additional stage in which the implant is placed on the ileostomy stoma. It takes a few weeks for healing around the implant and to adapt to the use of the implant.

  If converting an existing ileostomy, it is a relatively straightforward procedure that can be performed as minimally invasive surgery (laparoscopic technique).

• What literature is given to a patient prior to surgery?

  We supply a User Care Manual to each patient so that they have all the information to hand about the procedure, what to expect immediately after the surgery, and how to use the device day to day.

• Where is the pouch (reservoir)?

  Over time, the small intestine forms a reservoir in the abdomen before/prior to/inside the implant. Using the small intestine it is also possible to create a pouch in the part close to the implant during the surgical procedure but this is not necessary.

• How often do I have to empty?

  Emptying intervals vary greatly between individuals and are affected by food and fluid intake. The number of emptyings can vary from 2 to 10 times per day. Most patients empty every forth hour and some still use their bag some hours per day as an alternative. The important thing is that you, as a stoma user, will get much improved personal control of the process.

• What if I can't get to the toilet to empty it, will pressure affect the lid or cause a leak?

  Most patients are aware when they need to empty. There is a controlled build up in using the lid so that the patient is familiar with the number of times they need to empty. They can choose to put a bag on, if they believe they are unlikely to get to the toilet.

• How do you pass wind?

  The lid system isn’t designed to be worn 24 hours a day. It is designed to be used when the patient doesn’t want to wear a bag. Through the clinical trial, we haven’t had any negative reports about excess wind or gas build up. We would suggest a diet that doesn’t induce wind if possible.

• Is there a smell as there is no carbon filter?

  The lid seals the stoma and the clinical trial hasn’t provided any negative reports of smell.

• How do I clean the lid?

  You can just rinse the lid under a tap to ensure there is no waste left around the seal.

• Can I use a conventional ostomy bag in combination with the implant?

  The implant is fully compatible with bag use. If for any reason you wish to stop using the TIES lid, it is always possible to switch to traditional ostomy bags at any time without removing the implant, and then to switch back to the lid again, as desired.

• Does the TIES Solution require special training or skills to use?

  Daily life with the TIES Solution is simple and avoids the complications associated with the use and care of a conventional ostomy bag. It is important that during the initial period after surgery, when the ostomy is healing, it is well cared for to achieve a well-integrated and leak-free system.

• How long does the implant last?

  The TIES implant is designed for life-long use. It is made of pure and strong titanium metal that integrates permanently with the body and has no moving parts.

• How long does the lid last?

  The lid should be replaced every week. It can be cleaned by using warm water and soap.

• How much will it cost?

  The life-long cost of using the TIES Solution is expected to be similar to the use of conventional bags and other ostomy accessories. The company is working to obtain reimbursement for the device.

• Is it possible to remove the TIES implant?

  If for any reason you want to remove the implant, it can be removed and replaced with a conventional stoma using minimally invasive surgery.

• Are there any risks?

  There are always some risks involved when performing surgery; an ileostomy procedure is no exception to that rule. Implanting the TIES port following ileostomy is a small procedure and is not expected to alter the risk of ileostomy. Converting an existing ileostomy to TIES requires only minimally invasive surgery which is a simpler procedure than performing a new ileostomy. Infection and entero-cutaneous fistulas may occur following ileostomy, with or without the implant. Displacement of the implant is a potential risk and can be treated. Also as with a conventional ileostomy, there is a risk of developing a parastomal or incisional hernia.

  Premature use of the lid could cause insufficient ingrowth of the soft tissue into the device. To ensure a leak-free system, it is imperative to follow your doctor’s recommendation on when and how to start using the lid.

  It is possible that skin or body injury may occur if the protruding part of the implant is seriously damaged or be caught in violent accidents.

• Is there a risk of device displacements i.e. the TIES implant falls into the abdomen or falls out entirely?

  The tissue ingrowth as well as sutures maintains the device in situ. The only time displacement could be possible is from severe trauma or persistent heavy coughing immediately after surgery.

• Is TIES compatible with Magnetic Resonance Imaging (MRI)?

  

  Yes, the TIES system has been tested and validated to be MR Safe in a 3 Tesla MRI camera, according to the international standards ASTM F2182 and F2052. As expected no magnetic forces and no heating could be detected since there are no ferromagnetic materials in the TIES system, only pure titanium and plastics.

• Is TIES available in the US?

  We are currently planning to open a clinical trial in the US and we have initiated this process. Unfortunately, we cannot say when this process will be completed.