WARNINGS AND INDICATIONS

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The HALO³⁶⁰ System (inclusive of the HALO³⁶⁰ 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.

EU, Canada: The HALO³⁶⁰ System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to Barrett's Esophagus.

CONTRAINDICATIONS:

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

WARNINGS:

• Complications that have been observed in U.S. clinical studies include:  mucosal laceration and minor acute bleeding.
• 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, although drug treatment was continued indefinitely as underlying GERD remains in these patients.  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 positioning, inflation and energy delivery related to the HALO³⁶⁰ Ablation Catheter may result in a higher than expected rate of stricture formation after use of the device.  Specifically, failure to reposition the device adequately after delivering energy (move catheter linearly), before delivering the next treatment, may result in a deeper coagulation effect, thus resulting in a higher than expected rate of stricture formation.  The physician is warned to confirm adequate repositioning of the electrode balloon after each treatment is delivered, using endoscopic visualization, prior to initiating the next treatment cycle.  Minimize the overlap of ablation zone when moving the electrode linearly during each treatment pass.   
• Selecting a larger than recommended electrode size can result in trauma to the esophagus, excessive energy delivery, and stricture formation.
• Treating more than 6 cm of Barrett’s length in one treatment session may result in a higher than expected rate of stricture formation.
• Failure to clean the Ablation Catheter electrode and the lumen of treated esophagus after the first ablation pass may result in areas of under-treatment and over-treatment, and/or could reduce effectiveness and increase risk of complications.
• Failure to recognize information on Energy Generator LCD (display) after an operational code occurs indicating that partial ablation had occurred, then repeating the ablation in the same area, could result in excessive treatment to one region (stacking of ablation) and could lead to a higher than expected rate of stricture formation.  If the generator indicates an operational code, inspect the display to determine if energy was delivered.  Then inspect the ablation zone for treatment effect.  If any energy was delivered, move on to the next treatment area.  Do not retreat at the same location.

Note: Consult Instructions for Use for full contraindications, warnings, and precautions.