Based on prospective observational study of 67 patients that underwent
placement of LINX device between April 2012 and Dec. 2013, a 6-year single-center
prospective case series of 100 patients that underwent MSA, and an IDE
trial involving 100 patients implanted with LINX. Median operative times
were 60 minutes, 47 minutes, and 39 minutes, respectively.
Based on pivotal IDE trial of 100 subjects at 14 clinical sites. Half the
subjects (50/100) were discharged the same day as the surgery, and the
other half were discharged the next day.
https://www.ncbi.nlm.nih.gov/pubmed/30031018
Based on 5-year prospective, multi-center, single-arm study observing 100
patients who were implanted with LINX, bothersome heartburn was 89% at
baseline and decreased to 11.9% at 5 years. (p<0.001)
Ganz R. Edmundowicz S, Taiganides P, et al. Long-term Outcomes of Patients
Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal
Reflux. Clin Gastroenterol Hepatol. 2016. 14(5):671-7. Based on a study
observing 100 patients who were implanted with LINX, daily use of PPIs
decreased to 15.3% at 5 years. (p<0.001)
Ganz R. Edmundowicz S, Taiganides P, et al. Long-term Outcomes of Patients
Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal
Reflux. Clin Gastroenterol Hepatol. 2016. 14(5):671-7. Based on 5-year
prospective, multi-center, single-arm study observing 100 patients implanted
with LINX, regurgitation was 57% at baseline and decreased to 1.2% at
5 years. (p<0.001)