WARNINGS AND INDICATIONS

The HALO⁹⁰ Ablation System (inclusive of the HALO⁹⁰ Ablation Catheter) is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

CONTRAINDICATIONS:

• Pregnancy
• Prior radiation therapy to the esophagus
• Esophageal varices at risk for bleeding
• Prior Heller myotomy

WARNINGS:

• The following are side effects that may be expected after treatment (all transient): chest pain, dysphagia, odynophagia, throat pain and/or fever after treatment. Side effects should be managed by the physician at their discretion.
• Potential complications not observed to date in U.S. clinical trials include:
  
  
  • perforation of the stomach, esophagus, or pharynx;
  • surgery to correct perforation;
  • stricture formation requiring dilation;
  • infection;
  • pleural effusion;
  • arrhythmia;
  • major bleeding;
  • transfusion secondary to major bleeding;
  • aspiration;
  • death. 
• Vomiting post-treatment must be addressed by the physician, as it may result in more serious injury such as esophageal perforation, aspiration and possibly death.
• Previous stricture formation within the esophagus, dilation procedures within the esophagus, erosions of the esophagus, ulceration of the esophagus, ablative procedures of the esophagus, and/or resective procedures of the esophagus may predispose patient to esophageal stricture formation after treatment with this device given the altered anatomy, physiology and wound healing characteristics inherent to these disease states and therapies.
• Anti-secretory medication should be provided in a dosing regimen that fully controls GERD symptoms and heals esophageal inflammation, erosions and ulcerations prior to use of this device. In the AIM Clinical trials, high-dose proton pump inhibition (esomeprazole 40 mg bid) was provided for at least 7 days prior to and for at least one month after use of this device. Esomeprazole was reduced to 40 mg qd after healing of coagulated tissue was confirmed. Failure to provide adequate anti-secretory therapy at least 7 days before and after use of this device may lead to a higher rate of stricture formation than expected and/or persistence/recurrence of Barrett's esophagus.
• Failure to follow the instructions for use regarding the introduction, positioning, and energy delivery related to the HALO⁹⁰ Ablation Catheter may result in a higher than expected rate of complications after use of the device.
Note: Consult Instructions for Use for full contraindications, warnings, and precautions.