In Clinical Trials, the LINX Reflux Management System Stopped the Affliction in the Overwhelming Majority of Patients; 15 Percent of All Americans Suffer From the Often-Debilitating Condition
December 17, 2012 (Newswire) - Hoag Memorial Hospital Presbyterian recently became one of just three medical centers in California - the first and only in Orange County - to offer a highly promising new treatment for chronic reflux disease, an often-debilitating condition that afflicts 15 percent of Americans.
Known as the LINX Reflux Management System, the procedure stopped chronic reflux in 75 to 80 percent of all patients who participated in two national clinical trials. Following these successful clinical trials, the Federal Drug Administration approved the use of LINX this year, and Hoag performed its first procedure shortly after, in October.
"For millions of Americans who suffer from chronic reflux disease, one of life's normally most pleasurable experiences - enjoying a meal - can instead become a daily chore they anticipate with dread," said Dr. John C. Lipham, director of the Foregut Cancer Program and chief of USC Affiliated Academic Programs at Hoag. "In addition, chronic reflux can cause severe discomfort, robbing people of their sleep. Even in the limited time since its approval by the FDA, the LINX Reflux Management System has literally transformed the lives of our patients with chronic reflux disease."
Dr. Lipham served as principal investigator at USC for the FDA-regulated clinical trial of the LINX System and served as lead author of the official medical paper reporting on the four-year clinical data published in Surgical Endoscopy. Hoag was one of only three centers in the nation to participate in both FDA-regulated clinical trials for the LINX System. In addition to Dr. Lipham, his associate Dr. Nikolai Bildzukewicz also performs the LINX procedure at Hoag, having completed extensive training at UCSD, where the LINX procedure was first performed. Drs. Lipham and Bildzukewicz work in tandem, reviewing patient cases, and providing input on all patient care plans.
The LINX System is a laparoscopic outpatient procedure that involves the surgical placement of a small bracelet-like device of magnetic beads at the lower esophageal sphincter, a circular band of muscle that closes the last few centimeters of the esophagus and prevents the backward flow of stomach contents.
Dr. Lipham explained that the beads - which comprise of titanium and have a magnetic core - are connected with titanium wires in the shape of a ring. The force of attraction of the magnetic beads is designed to provide additional strength to keep a weak valve closed. When a person swallows, the magnetic force between the beads is overcome by the higher pressure of the force of swallowing, causing the device to expand to accommodate food or liquid. Once the food or liquid passes though the valve, the LINX device returns to its normal state of keeping the valve closed.
As just one example of the procedure's effectiveness, Dr. Lipham recently treated a woman in her early 40s whose reflux was so severe that she had to sleep upright in a recliner. Even on heavy doses of medication, she still suffered from bad heartburn and at times would aspirate material into her lungs. But following the LINX System procedure, she no longer suffers from chronic reflux, he said.
After LINX surgery, patients usually are able to return to a regular diet in just three to four weeks - compared to eight to 12 weeks following another surgical approach known as Nissen fundoplication, according to Dr. Lipham, who has been involved in testing and refining the LINX System for more than five years. Hoag is one of only three centers in all of California implanting these devices, through the Hoag-USC Surgical Center for Digestive Diseases.
About Hoag-USC Surgical Center for Digestive Diseases
Established in 2011, Hoag and the Keck School of Medicine at the University of Southern
California (USC) formed a unique partnership to provide Orange County patients access to a team of nationally recognized surgeons who treat complex diseases of the esophagus, stomach, liver, pancreas and duodenum. This multidisciplinary team of physicians performs the highest volume of complex procedures in Southern California. The team includes:
• Nikolai Bildzukewicz, M.D. - Esophageal and Gastric Surgeon
• Au Bui, M.D. - Hepatobiliary Surgeon
• John Lipham, M.D. - Esophageal and Gastric Surgeon
• Phuong Nguyen, M.D. - Advanced Endoscopy Specialist
• Robert R. Selby, M.D. - Hepatobiliary Surgeon
• Maria Stapfer, M.D. - Hepatobiliary Surgeon
About Hoag Memorial Hospital Presbyterian
Hoag is an approximately $1 billion non-profit, regional health care delivery network in Orange County, California, that treats nearly 30,000 inpatients and 350,000 outpatients annually. Hoag consists of two acute-care hospitals, seven health centers, and five urgent care centers. Hoag Hospital Newport Beach, which has served Orange County since 1952, and Hoag Hospital Irvine, which opened in 2010, are designated Magnet hospitals by the American Nurses Credentialing Center (ANCC). Hoag offers a comprehensive blend of health care services that includes five institutes providing specialized services in the following areas: cancer, heart and vascular, neurosciences, women's health, and orthopedics through Hoag's affiliate, Hoag Orthopedic Institute. Hoag has been named one of the Best Regional Hospitals in the U.S. News & World Report Metro Edition. National Research Corporation has endorsed Hoag as Orange County's most preferred hospital for the past 16 consecutive years and, for an unprecedented 16 years, residents of Orange County have chosen Hoag as the county's best hospital in a local newspaper survey. Visit www.hoag.org for more information.