Topic Explanation
The forum discussion revolves around advancements in 3D titanium printing technology, specifically focusing on the TIES (Transcutaneous Implant Evacuation System) implant device developed by OstomyCure. The TIES implant is a titanium port designed to be implanted within a stoma, allowing patients to control the emptying of their stoma at their convenience, rather than continuously into a bag. The discussion includes insights from an article detailing the development and clinical trials of the TIES implant, as well as personal experiences and opinions from forum participants.
Advice and Insights
1. Clinical Trials and Patient Experiences:
- The TIES implant has been in development for over a decade and has reached a milestone in its pivotal clinical trial with 20 patients implanted in various countries.
- Patients will be monitored for six months to assess the safety and performance of the device, with data being compiled for EU regulatory submissions.
- Personal experience from a forum participant indicated initial tolerance but eventual failure of the device, leading to significant adverse reactions and the need for surgical removal.
2. Design and Manufacturing:
- Early iterations of the TIES implant were made using conventional manufacturing, which was complicated and expensive.
- 3D printing allowed for optimization of the design and improved the surface for tissue in-growth.
- The lid design has evolved through multiple generations to address issues such as user-friendliness and leakage.
3. Regulatory and Ethical Considerations:
- There is a call for legislation to ensure companies support and compensate patients harmed by experimental procedures.
- Transparency in trial data and outcomes is crucial, and there should be no 'gagging orders' preventing participants from speaking about negative experiences.
- Companies should secure adequate funding and ensure all components of a system are thoroughly tested before trials.
4. Alternative Solutions and Long-term Viability:
- Some patients prefer traditional ostomy bags and wafers due to their external placement and ease of monitoring.
- The TIES implant is not suitable for patients with Crohn's disease, as indicated by trial outcomes.
- Other devices like BCID and inner pouch systems are also under development but are not yet widely available or without complications.
5. Future Availability and Development:
- The TIES implant still needs to pass through more trial stages and obtain CE Mark status in Europe and FDA approval in the US.
- It is unlikely to become a routine procedure in
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