The StomaphyX™ device is a sterile, single-use device for use in transoral tissue approximation and ligation in the GI tract.
Indications:
The StomaphyX™ is a pioneering device for Natural Orifice Surgery (NOS).
Without incisions and with minimal patient downtime, StomaphyX can be used to create durable large tissue folds in the gastrointestinal tract.
Performed under endoscopic visualization, StomaphyX™ is introduced into the body transorally (through the mouth).
Once inside the stomach, the stomach wall is suctioned into the tissue port on the StomaphyX™ creating a large plication.
Non-resorbable fasteners are then deployed across the fold to hold the tissue in place. Typically 10 to 20 folds are required depending on patient anatomy.
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.
Multiple Fasteners-Single insertion:
StomaphyX™ is the first transoral, fastener delivery system capable of delivering multiple fasteners with a single insertion allowing the procedure to be easily and atraumatically customized to the patient's anatomy and individual needs. Coupled with patented SerosaFuse™ fastener technology, StomaphyX enables the creation of multiple, large, durable plications to deliver the results that patients need.
Benefits:
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 herniationis used to draw a large fold of tissue into the tissue port.
Customizable to patient needs
Delivers an unlimited number of fasteners with a single insertion
to meet the needs of each individual anatomy.
Adjustable and/or revisable transorally to preserve future treatment options
Minimizes patient downtime.
Most patients can return to work in as little as one day.
No external incisions and no internal dissection minimizes patient
discomfort and shortens recoveryfold.
Features:
Transoral insertion.
Delivers unlimited fasteners with a single insertion.
Adjustable and/or revisable transorally.
No abdominal incision.
No internal incisions.
SerosaFuse™ Fasteners:
Made of polypropylene, equivalent web strength to 3-0 suture.
Holds full thickness, serosa-to-serosa plications to enable serosal fusion.
Open ended fastener design, not likely to surround and trap nerves
or blood vessels.
