For Surgeons

 

Real Results Without Incisions

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	Q:	What is StomaphyX?
	A:	Designed for use in Natural Orifice Surgery (NOS), StomaphyX is an innovative single-use surgical device for use in transoral tissue approximation and ligation in the GI tract.
	Q:	What is the procedure like?
	A: Without incisions and with minimal patient downtime, StomaphyX can be used to create durable large tissue folds in the gastrointestinal tract. StomaphyX is introduced into the body transorally (through the mouth), and the procedure is performed under endoscopic visualization. Once the StomaphyX device is inside the stomach, the stomach wall is suctioned into the device's tissue port, creating a large plication. Non-resorbable fasteners are then deployed across the fold to hold the tissue in place. Typically 20 or more folds are required depending on patient anatomy.  Before Treatment After StomaphyX showing creation of large tissue folds

Suction is used to draw a large fold of stomach wall 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 the EGS' patented SerosaFuse fastener technology, StomaphyX enables the creation of multiple large, durable plications to deliver the results patients need.
		Before   After (Zoomed in) Photos courtesy of Jacques Himpens, MD, Dendermonde, BE.
	Q:	How long does the procedure take?
	A:	Most procedures are completed in 20-30 minutes.
	Q:	What is the recovery like?
	A:	Most patients can return to work the next day or within a few days following their StomaphyX procedure. Patients should expect to experience some discomfort in their chest, nose and throat for the first few days to a week after the procedure. Patients will be asked to restrict physical activity for the first week and will be given dietary guidelines to help maximize their success while the plications heal. Typically a soft/liquid diet is required for 10 days to two weeks to protect the newly altered geometry.
	Q:	How safe is the StomaphyX procedure?
	A:	StomaphyX has been shown to be safe in use in hundreds of procedures worldwide. To date, side effects have been minimal and transient. The StomaphyX procedure is expected to be safer than traditional surgery which often involves incisions in the skin for access to the organs, and cutting around the organs to free the desired area for suturing. With StomaphyX, there are no incisions inside on the organs or outside on the skin. This reduces or eliminates the risk of incisional herniation, infection, adhesions or visible scarring. StomaphyX procedures are particularly attractive replacements for revisional surgery because revisional surgery is among the most complex and dangerous types of surgery.

Benefits:

• Safe and atraumatic 
  • Incisionless transoral insertion reduces/eliminates risk of infections and incisional herniation
  • Flexible shaft for atraumatic insertion
    
  • Stylet enclosed within shaft during insertion, procedure and withdrawal
    
• 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 recovery

Features:

• Transoral insertion
• Delivers unlimited fasteners with a single insertion
• Adjustable and/or revisable transorally
• No abdominal incisions
• No internal incisions

SerosaFuse® Fasteners:

	SerosaFuse fastener

• Made of non-resorbable polypropylene, equivalent web strength to 3.0 suture
• Holds full-thickness serosa-to-serosa plications to enable serosal fusion
• H-shaped, 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
• Proof of concept: 2-year follow-up on SerosaFuse fasteners¹

1 Serosa-to-serosa plications and 2-year durability testing with SerosaFuse fasteners inserted with EsophyX device.

How do I arrange an in-service meeting with my local EGS sales representative:

Either click the Request Info button below or call (650) 226-2200 to arrange an in-service meeting with your local EGS rep.

How do I get trained on the StomaphyX procedure:

To arrange training at one of our training locations, either click the Request Info button below or call (650) 226-2200 to contact you local EGS rep.

Patient brochure downloads:

• StomaphyX Patient Education Brochure (PDF, 1.75MB)
  
• StomaphyX Patient Instructions Brochure (PDF, 1.78MB)

Surgeon brochure downloads:

• EsophyX/StomaphyX Product Brochure (PDF, 2MB)

 

 

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