Effective Results

In clinical trials evaluating the Stretta procedure over 75% of patients experienced a positive response to treatment. Studies have shown a significant improvement in GERD symptom scores for heartburn, patient satisfaction, and quality of life. In many cases Stretta has eliminated or decreased the need for medication and these results are sustained over 4 years of follow-up. Any side effects of Stretta are less than those associated with surgery and patients that fail to improve after this treatment may go on to have surgery at a later date.

Stretta patients were 90% satisfied with this treatment – and would recommend the Stretta treatment to a friend with GERD.

FAQ’s

What can I expect in terms of my recovery after the Stretta Procedure?
Patients are advised to restrict their diet to liquids for 24 hours after the procedure, followed by a soft diet for the next 7 days. Most patients are able to return to normal activities the following day.

Will I experience any pain during or after the Stretta Procedure?
Some patients experience mild chest or abdominal discomfort during the procedure, which may be alleviated with additional sedation medications. In the days following the procedure, patients may feel tenderness in the chest or upper abdomen, which typically improves in 3 to 5 days.

How soon will I experience improvement after the Stretta Procedure?
Patients typically remain on their GERD medications for 8 weeks following the procedure. After this period, your physician may discontinue or reduce your medication according to your symptom response to the procedure.

 

SAFETY INFORMATION

INDICATIONS FOR USE: The Stretta System is intended for general use in electrosurgical coagulation of tissue and intended for use specifically in the treatment of gastroesophageal reflux disease (GERD).

CONTRAINDICATIONS:
There are no known absolute contraindications to the use of radiofrequency in humans. The use of the Stretta System is contraindicated when, in the judgment of the physician, radiofrequency surgical procedures would be contrary to the best interests of the patient. The following is a list of patient groups in whom the use of the Stretta System for the treatment of GERD may be contraindicated: Subjects under the age of 18; Pregnant women; Patients without a diagnosis of GERD; Hiatal hernia > 2 cm; Achalasia or incomplete LES relaxation in response to swallow; Poor surgical candidate.

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: 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 (alphabetical order): Bleeding – transient; Bloating; Chest pain - transient; Difficulty belching – transient; Dysphagia – transient; Epigastric discomfort – transient; Esophageal mucosal laceration; Fever - transient; 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 (alphabetical order): Achalasia; Delayed gastric emptying – transient; Dental injury; Dyspnea; Infection; Larynx injury; Worsened GERD.