Understanding GERD. & Stretta Therapy. GERD (gĕrd): Gastroesophageal Reflux Disease

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Understanding GERD & Stretta Therapy GERD (gĕrd): Gastroesophageal Reflux Disease

What is GERD? When the muscle between your stomach and esophagus is weak, stomach contents like acid or bile can reflux up into your esophagus causing GERD symptoms. Chronic symptoms occurring more than twice a week may be considered GERD.

GERD Treatments Medications (PPIs) ANTI-REFLUX SURGERY: Transoral Fundoplication Surgically Implanted Devices Laparascopic Fundoplication 70% Respond to Meds 25-30% Refractory GERD 5% Have Anti-Reflux Surgery Invasive Surgery 30% don t get complete relief from PPIs* and many more are concerned about the risks of long term medications and don t want to have surgery. Stretta fills this treatment gap! *Kahrilas et al. Best practice & research Clinical gastroenterology. 2013;27(3):401-414. doi:10.1016/j.bpg.2013.06.005.

What is Stretta? Stretta is a non-surgical, outpatient procedure that treats the underlying cause of GERD a weak muscle between the stomach and esophagus. Stretta Medical has been shown to: Significantly Management reduce GERD symptoms Eliminate or decrease medications Decrease acid exposure Improve quality of life Invasive Surgery Kit Lo, et al. Journal of Clinical Gastroenterology: October 2015 - Volume 49 - Issue 9 - p 720 724

The Stretta Procedure Outpatient procedure Takes less than 60 minutes Conscious sedation or general Upper endoscopy performed Stretta is introduced transorally Prongs on the end of the device deliver low levels of radiofrequency energy into the muscle between your stomach and esophagus

Stretta Therapy How it Works Treatment is delivered at multiple levels in lower esophagus RF energy stimulates the muscle to grow over time* After the sedation wears off, you can be taken home Treatment goal: a thicker muscle to improve barrier function and prevent all types of reflux events (acid, bile, etc.) *Herman, et al. Colorectal Disease: May 2015 17:433-440

The Healing Power of RF Energy Radiofrequency energy is widely used in healthcare: Cardiologists use RF to treat atrial fibrillation Urologists use RF for treating prostate enlargement ENTs use RF to eliminate snoring and sleep apnea RF is used in cosmetic procedures for body contouring, skin rejuvenation and tightening Animal studies show that the technology used in Stretta may increase smooth muscle and improve collagen in the treatment zone.* *Herman, et al. Colorectal Disease: May 2015 17:433-440

Stretta Widely Studied More than 20,000 Stretta procedures performed 40 clinical studies conclude Stretta safe and effective Low complication rate <1% (similar to EGD) 93% patient satisfaction after Stretta Long term data 4-year follow-up 86% of patients off daily PPIs 8-year follow-up 72% of patients off daily PPIs 10-year follow-up 64-72% of patients off PPIs Perry et al. Surgical Endocopy 27: 2658-2672 Noar, et al August 2014. Surgical Endoscopy 28, 2323-2333

What to Expect After Stretta Expect to feel very tired for rest of the day Most common side effect is a sore throat or mild chest soreness (may continue for 1-5 days) Some feel bloated, increased belching and gas Resume normal activities as tolerated, the next day Follow all post-procedure instructions provided Continue taking your acid controlling medications until instructed by your physician (at least 2-months after Stretta)

What to Expect After Stretta Do not expect symptoms to improve immediately The effects develop slowly over time Some patients improve faster than others Your physician will begin to wean you off of your PPI medications approximately 2-months after Stretta Most patients start to see improvements in 2-4 months May take as long as 8-12 months

Post Stretta Patient Instructions Avoid instrumentation of the esophagus for at least one month after treatment, specifically the passage of a nasogastric tube. Refrain from use of oral NSAIDS for 14-days after Stretta. Use liquid acetaminophen, with or without codeine or equivalent preparation, for post treatment analgesia. Crush all medications or use liquid preparations of all medications, for at least one month after treatment. Modify diet post Stretta: full liquids for 24 hrs, soft diet for 2-weeks. Continue previous GERD medication regimen for 2-months after the Stretta procedure. Notify the physician if any of the following symptoms occur: Fever, chest pain, nausea, vomiting, bleeding, shortness of breath, increasing abdominal discomfort, difficulty swallowing, tachycardia.

Advantages of Stretta Middle option fits between medications and surgery Non-surgical and outpatient procedure Low complication rate Does not alter patient anatomy Widely studied with long-term follow-up Cost effective when compared to long-term medications or surgery

Stretta Patient Profile Don t respond completely to PPIs Have drug interactions with or are intolerant of PPIs Are concerned about side effects of long-term PPI use Want to avoid anti-reflux surgery Experience non-erosive reflux (NERD) Have respiratory GERD symptoms (cough, asthma, etc) Have recurring reflux after anti-reflux surgery Still have GERD after bariatric surgery

Stretta Contraindications Patients 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

For people with GERD who need an alternative to medications or surgery. The next wave in GERD treatment Stretta. stretta-therapy.com

Stretta Safety Information 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 >2cm, achalasia or incomplete LES relaxation in response to swallow, poor surgical candidates, ASA IV classification. 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).