Regulatory Labeling

Regulatory Status

• United States: EsophyX® Fastener Delivery Devices with SerosaFuse® Fasteners are Class II and 510(k) cleared by the US Food and Drug Administration. Type “EsophyX” into the [Device Name] search box here to get copies of the letters.
• On June 22, 2017, a sentence was added to the EsophyX device indication statement: Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.*
• European Union: The EU granted CE mark to the EsophyX device in 2006.

Indications

The EsophyX device, with SerosaFuse® fasteners and accessories, is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2 cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2 cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less.

Contraindications

The TIF procedure may not be a good fit if the patient:

• Has a bleeding disorder, chronic uncontrollable cough, stricture, severe esophagitis, esophageal diverticulae, an obstruction, a paraesophageal hernia, limited neck mobility, osteophytes of the spine, esophageal varices, esophageal infections or fungal disease, or esophageal stenosis.
• Has any kind of normal or abnormal esophageal anatomy which would prohibit insertion of the EsophyX device.
• Is unable adhere to the post-operative diet recommended for appropriate healing.
• Is under 18 years old.
• Has a hiatal hernia greater than 2cm in size.
• Has a BMI greater than 35.

Risks of the TIF Procedure

Expected risks or discomforts anticipated as a result of an endoscopic procedure include:

• Sore throat, hoarseness, lump in throat feeling (globus pharyngis)
• Temporary difficulty (dysphagia) or painful swallowing (odynophagia) due to swelling or tissue manipulation
• Nausea, gagging, or vomiting
• Left shoulder pain from C02 insufflation
• Temporary abdominal or other pain which can be treated with standard pain medication

Usually mild in severity and resolving themselves shortly after surgery, these expected events occur in greater than 25% of people who have the TIF procedure. Serious adverse events have been reported in less than 0.4% of all commercial procedures.

Potential Adverse Events

Details of foreseeable adverse events (AE) and adverse device effects (e.g., serious / non-serious device related / non-related) are as follows

Typical known risks or discomforts anticipated as a result of an endoscopic procedure:

• Temporary dysphagia (difficulty swallowing) or odynophagia (painful swallowing), due to swelling or tissue manipulation, hoarseness, gagging, globus pharyngis, or other temporary pain which responds to standard pain medication.
• Inflammation reaction from lubricant
• Endoluminal gas bubbles

Unusual risks or discomforts as a result of an endoscopic procedure:

• Injury of mouth and/or teeth, bite block related injury, persistent odynophagia or dysphagia requiring intervention, bleeding, perforation, abrasion, hematoma/edema, laceration, esophageal tear, gas bloat, dyspepsia, diarrhea, infection, fistulae between inner organs, vomiting, nose bleeding from nasal intubation, vocal cord nodules due to intubation, hiccups, and limited neck mobility.
• Rare risks as a result of an endoscopic procedure and of this particular procedure: Lockjaw, aspiration, hypoxia, achalasia, nerve damage, focal necrosis, tissue damage, ulceration/abscess, gastrointestinal and pancreatic leaks, pancreatitis, acute abdomen, peritonitis, bowel obstruction, pericardial effusion, capture of other inner organs which may neighbor the suturing site or resulting from adhesions from previous abdominal infections or surgical procedures, potentially resulting in fistulae between inner organs or the inner organs and the abdominal or thoracic cavity, pneumothorax, thoracic, mediastinal, or abdominal abscess, mediastinitis, pneumoabdomen, bleeding requiring blood transfusion, surgery for uncontrolled bleeding and/or perforation, chest pain, cardiac event, ulcer, medical or surgical treatment as a result of the occurrence of complication, procedure related failure requiring medical intervention or surgical conversion, embolism, death.

TIF Procedure is Revisable

It is important to remember that GERD is a chronic disease that requires a lifetime of management to control symptoms. As with laparoscopic procedures, in a minority of patients, additional surgery is sometimes desired for more adequate symptom relief. In a study published in 2014, 28 patients who were previously treated transorally underwent a subsequent laparoscopic Nissen fundoplication safely and effectively.

C.W. Bell, et all. Surg Endosc (2015) 29:1746-1752