INDICATIONS FOR USE: The Stretta System is intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of gastroesophageal reflux disease (GERD).
CONTRAINDICATIONS: The use of electrosurgery is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interest of the patient. The following is a list of patient groups in which the use of the Stretta System for the treatment of GERD is contraindicated: subjects under the age of 18, pregnant women, patients without a diagnosis of GERD, hiatal hernia >3cm, achalasia or incomplete LES relaxation in response to swallow, poor surgical candidates, ASA IV classification.
WARNINGS: The following is a list of patient groups who have not been specifically studied using the Stretta System for the treatment of GERD. The performance characteristics of the device for the following groups of patients have not been established.
- Patients with an implant near the LES that could be conductive with RF energy
- Normal 24-hour pH study
- ALL GERD symptoms completely unresponsive to properly dose-escalated anti-secretory medication
- Barrett’s metaplasia
- Poor surgical candidate
- Presence of dysphagia, esophageal bleeding, or gas bloat
- Active esophagitis grades III or IV by Savary criteria
- Endocarditis risk (mitral valve prolapse, heart valve replacement, etc.)
- Untreated or unstable hypertension, diabetes mellitus, heart disease, collagen vascular disease, steroid use, immunosuppressed state, or cardiac pacemaker
- Abnormal blood coagulation or use of anticoagulant or platelet anti-aggregation therapy.
WARNINGS: These complications are rarely seen but could potentially occur with the use of electrosurgery for the treatment of GERD: transient bleeding, bloating, transient chest pain, transient difficulty belching, transient dysphagia, transient epigastric discomfort, transient esophageal mucosal laceration, transient fever, Injury to esophageal mucosa, perforation, pharyngitis, vomiting transient with potential for bleeding or Esophageal injury. If any vomiting occurs, contact your treating physician immediately. Excessive vomiting may result in perforation and more serious injury resulting in death. The following complications have not been seen, but could possibly occur infrequently: Achalasia, transient delayed gastric emptying, dental injury, dyspnea, infection, larynx injury, worsened GERD (Note: Consult instructions for use for full contraindications, warnings and precautions).