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CALIBER clinical trial

LINX Reflux System beats standard medical therapy for GERD

89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the six-month primary endpoint
81 percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD–health-related quality of life scores (p<0.001)

The results of the CALIBER clinical trial has revealed that Linx Reflux Management System was significantly more effective in relieving symptoms and improving quality of life gastrointestinal reflux disease (GERD) than taking twice-daily acid suppression drugs. The Linx Reflux Management System is indicated for those patients diagnosed with GERD as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy.

Linx Reflux Management System

The Linx System works by correcting a mechanical failure in the lower oesophageal sphincter (LES), the body’s natural barrier to reflux. The magnetic band expands when a patient swallows to allow food to enter the stomach but then contracts to prevent stomach contents from flowing back into the oesophagus.

The outcomes were revealed in the paper, ‘Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial’, published in GIE: Gastrointestinal Endoscopy, the peer-reviewed journal of the American Society for Gastrointestinal Endoscopy (ASGE).

The CALIBER study, is the first randomised controlled clinical trial to compare the anti-reflux procedure to proton pump inhibitors (PPIs), the standard of medical care for GERD treatment. In the CALIBER study, patients with GERD and moderate-to-severe regurgitation despite eight weeks of treatment with once-daily omeprazole, were randomised to either receive twice-daily doses of the PPI or undergo a minimally invasive procedure with the LINX System.

Dr Reginald C W Bell

"It is sometimes said that GERD patients who don’t respond to medication will not do well with surgery,” said Dr Reginald C W Bell, the study co-author and a gastrointestinal surgeon at Institute of Esophageal and Reflux Surgery in Englewood, CO. “This study demonstrated that patients experiencing regurgitation despite proton-pump inhibitor therapy actually did extremely well with an anti-reflux procedure, magnetic sphincter augmentation, using the LINX device. When the physiology of GERD is recognized – that it is due to a mechanical defect in the sphincter – it makes sense that patients would indeed respond to the procedure.”

For the study, 152 patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite eight weeks of once-daily PPI therapy, were prospectively enrolled at 21 US sites. Participants were randomised 2:1 to treatment with twice-daily (BID) PPIs (n=102) or to laparoscopic magnetic sphincter augmentation (MSA, Linx Reflux Management System, Ethicon) (n=50). Standardised foregut symptom questionnaires and ambulatory oesophageal reflux monitoring were performed at baseline and at six months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in oesophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy.

The study found:

  • 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the six-month primary endpoint
  • 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (p<0.001)
  • 81 percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD–health-related quality of life scores (p<0.001)
  • A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (p<0.001) and 75% (59/79) (p=0.065) of BID PPI patients at six months.
  • 81% of patients treated with LINX reported satisfaction with their current condition versus 2% of patients treated with twice-daily omeprazole

In addition, the investigators reported no significant safety issues, MSA patients, 28% reported transient dysphagia; 4% reported ongoing dysphagia.

“MSA provides significantly better control of moderate-to-severe regurgitation when compared with BID PPI therapy,” the authors concluded. “Patients with GERD and inadequately controlled regurgitation after initial dosing of acid-suppressive medication should be considered for minimally invasive surgical treatment with the MSA rather than treatment with increased does of medication.”

“This study demonstrates the Linx System offers significant advantages over medical therapy in patients with GERD who suffer with regurgitation,” said Michael del Prado, Ethicon Company Group Chairman. “Ethicon will continue to generate clinical and real-world evidence that enables clinicians, patients, insurers and health systems to make the best possible decisions about which treatments work best for which patients.”

The Linx System is available in the US and throughout Europe.

To access this paper, please click here

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