PRODUCT: StomaphyX / Surgeons
 |
|
Bariatric Revision Without Incision
|
Now there is a "no incision" solution for post bariatric patients who...
|
●
|
Need a little help for continuing weight loss |
|
●
|
Have experienced some weight regain |
|
●
|
Are suffering from heartburn/reflux |
|
●
|
Are experiencing severe dumping syndrome (including symptomatic hypoglycemia and diarrhea) |
Indication:
StomaphyX is a sterile, single-use device for transoral tissue approximation, ligation and full thickness plication in the gastrointestinal (GI) tract. The device typically is used in performing gastric pouch reduction surgery for bariatric patients who have regained significant weight in the years following a successful gastric bypass surgery.
Procedure overview:
Without any external incisions or internal dissection, StomaphyX is used to create durable, large serosa-to-serosa tissue folds in the gastric pouch to reduce its total volume and compliance. Performed with the patient under general anesthesia, the StomaphyX device is introduced into the body transorally (through the mouth) under endoscopic visualization and advanced into the pouch. Once inside the patient's pouch, a small section of tissue is suctioned into a port on the StomaphyX device's distal end to create a large full-thickness plication. Non-resorbable fasteners, called SerosaFuse fasteners, are then deployed across the fold to hold the tissue in place. Twenty or more folds may be required depending on the patient's anatomy. Within the weeks following surgery, serosa to serosa fusion cements the plications and reduces compliance of the pouch. A smaller, less compliant pouch slows the flow of food into the intestine and returns the feeling of satiety, which when combined with a healthy eating and exercise program can lead to weight loss.
|
Before Treatment
|
|
After StomaphyX showing creation of large tissue folds and reduction of size and volume
|
The advantages of incisionless transoral surgery over laparoscopic or open surgery include:
- Minimizes/eliminates risk of infections, incisional herniation
- No visible scars
- Lowers hurdle for having surgery performed, allowing for earlier surgical intervention
- Most procedures completed in 20-30 minutes
- Shorter hospital stay
- Reduced patient discomfort
- Shortened patient recovery
- Patients can return to work and normal activities in as little as one day
- Typically higher patient satisfaction
How StomaphyX Works:
 |
|
 |
|
 |
|
Suction is used to draw a large fold of tissue into the tissue port
|
|
The stylet remains safely within the shaft of the device and leads the fastener across the base of the tissue fold
|
| Before |
|
After (zoomed in) |
 |
|
 |
| |
|
Enlarged Stoma
|
|
Showing Large Plications and effective reduction of stoma
|
SerosaFuse® Fasteners:
- Made of non-resorbable polypropylene, equivalent web strength to 3.0 suture
- Holds full-thickness serosa-to-serosa plications to enable serosal fusion
- H shape, open-ended fastener design, not likely to surround and trap nerves or blood vessels
- Larger than stylet - reduces the incidence of bleeding
- Non-resorbable, continues to hold
- Reduced patient discomfort
- Proof of concept — 2-year follow up on SerosaFuse fasteners [1.]
|
|
 SerosaFuse fastener |
[1.] Serosa to serosa plications and 2-year durability testing with SerosaFuse fasteners inserted with EsophyX device.
What results should the patient expect from the StomaphyX procedure?
Results vary from patient to patient, but the StomaphyX component of the complete revisional gastric bypass procedure typically plays an important role in the patient's experiencing significant weight loss and a much higher satiety score in the first three to six months following the procedure.
About StomaphyX Plus:
- Specially designed to be soft and flexible for atraumatic insertion yet responsive to movement and torque
- Unlimited fasteners with single insertion allows procedure to be customized atraumatically
- Stylet remains under visualization within the device shaft during insertion and procedure for maximum safety
|
|
|
Benefits of the StomaphyX procedure:
- Safe and atraumatic
- Flexible shaft for atraumatic insertion
- Stylet enclosed within shaft during insertion, procedure and withdrawal
- Incisionless transoral insertion reduces/eliminates risk of infections and incisional herniation
- Customizable to patient needs
- Delivers an unlimited number of fasteners with a single insertion to meet the needs of each individual anatom
- Adjustable and/or revisable transorally to preserve future treatment options
- Minimizes patient downtime. Most patient can return to work in as little as one day
- No external incisions and no internal dissection minimizes patient discomfort and shortens recovery
Other StomaphyX Information:
Patient Brochure Downloads:
Surgeon Brochure Downloads:
How to Order:
Contact us for more information on the StomaphyX distributor in your area.
EsophyX is FDA cleared and CE marked and available throughout the European Union, the U.S, and other parts of the world.
C01799-01 A
| 
