Color Logo for MeetAnOstoMate
Sponsored by Hollister
Login   |  
Forgot password?
 
Forum
Videos
Reviews
About Us
Color Logo for MeetAnOstoMate
Where Everybody Understands You
41,452 members
Mar 13, 2014

New Bionic Sphincter/valve Designed to Eliminate the Need to Wear Collection Bags (Going Thru FDA Approval Process)

The topic is about an innovative medical device being developed to potentially eliminate the need for external ostomy bags. This device is a bionic sphincter or valve implant designed to be surgically placed around the intestinal or urinary conduit leading to a stoma. Here are some key points and insights about this development:

- The device functions with a plunger that can open or close the canal, controlled by the patient using a remote similar to a car key fob.
- During bathroom visits, the user can open the valve, attach a reusable funnel, and empty directly into a toilet, which removes the need for disposable bags and related supplies.
- The implantation procedure is described as straightforward, taking less than 20 minutes in animal tests, with half of that time spent on closing the skin.
- The company is preparing for final human trials and seeking regulatory approvals. They are also looking for feedback and support from the ostomy community to help overcome resistance from established pouch manufacturers.

Additional details about the device include:

- It consists of a ring valve around a short segment of the intestine, with a plunger connected to a cable driven by a small motor in a control box placed under the skin near the stoma.
- The remaining bowel acts as an internal reservoir, and the time between bathroom visits depends on how much intestine the patient retains.
- The device is activated by pressing a button on the remote, which moves the plunger to open or close the valve.
- The company will not ask for money from patients but encourages public support to speed up regulatory reviews, with potential faster clearance in Europe, Mexico, and Brazil.
- If trials and approvals go smoothly, the device could be commercially available in some markets within about two years.
- This device is different from other products like the BCIR and ColoSafe, as it is smaller, fully implantable, and electronically controlled.

Advice and insights from the community include:

1. There is strong enthusiasm, with many members volunteering for clinical trials and highlighting the life-changing potential of a bag-free option.
2. There are requests for more technical details, such as comparisons with other devices, cleaning and sterility concerns, risk of infection, how fullness will be sensed, and worries about accidental activation.
3. Members caution about potential insurance and regulatory challenges in the U.S. and suggest pursuing faster approval pathways in Europe.
4. Recommendations for communication include posting a full profile, joining multiple ostomy forums and blogs, and providing transparent updates to build trust.
5. Users share testimonies about the difficulties with current pouches, such as leaks, costs, social stigma, and impacts on relationships and clothing, emphasizing how an internal valve could restore confidence and normalcy.
6. While some humorously mention future possibilities like 3-D-printed colons, most agree that an interim, minimally invasive valve available soon would be a significant advancement.
7. Comparable products mentioned for reference include the BCIR continent procedure and the ColoSafe device.
See full discusison
Gray Logo for MeetAnOstoMate
MeetAnOstoMate.org

MeetAnOstoMate is a remarkable community of 41,452 members.

“I mostly read and still feel like I belong.”

“Doctors took notes; they want others to find this website.”

“From midnight blowouts to big wins, there’s always a hand to hold.”

Join Free

Popular Topics

Newbie
Hello new friends!
UOAA Conference Photos
Travel Tips for Ostomates Visiting Switzerland
Meanwhile, back at the beach
Not much to tell really.
Positive outcomes
You Might be an Ostomate if...
Metamucil Success: A Simple Suggestion from My New Gastro Doctor
New to Colostomy: Can I Eat Popcorn or Mango?

New Topics

Munro Bagging Adventures and Challenges
Hello
Newbie Alert… Simon, an anti-help group dude seeking a help group lol
Going on dialysis after having lived with a colectomy for years
Running with a Urostomy Bag: Seeking Advice on Belt Issues
Acid burns and skin irritations due to leakages
B.Withers - B.Kind 58
Sigmoid Loop Colostomy Reversal: Seeking Advice and Support
Not Exactly an Introduction
Pain Relief Tips After Barbie Butt Surgery
About us | Privacy policy | Terms of use | Ostomy Blogs | Ostomy Q&A | Guides | Contact Us
This site is protected by reCAPTCHA and Google Privacy Policy and Google Terms of Service apply.
Copyright (c) MeetAnOstoMate.org All Rights Reserved
Create Account
Login
↑