Mayo Clinic announced Wednesday that its Jacksonville, Florida campus will become one of the first providers in the nation to offer a novel implant procedure to treat acid reflux for those who don’t respond to medication.
The product is the LINX Reflux Management System made by Twin Cities-based Torax Medical. The device earned approval from the U.S. Food and Drug Administration in late March. It uses a small, flexible band of interlinked titanium beads wrapped around magnetic cores, which is laparoscopically implanted around the esophageal sphincter. The magnetic attraction is designed to resist the opening of the sphincter to gastric pressure, thereby preventing the entry of stomach acids into the esophagus. At the same time, much higher pressures from swallowing can overcome the magnetic pull and allow food and liquid to pass normally into the stomach.
The new treatment will be offered immediately. Smith is familiar with the LINX system because the Florida campus was one of 14 centers that participated in the clinical trial that led to the product’s approval. Smith performs about 200 GERD-related surgeries a year and has been involved with many new treatments over the past several decades.
“I expect this device to be a game changer for the treatment of [gastrointestinal reflux disease] in select patients who have failed management with drugs,” said Dr. C. Daniel Smith, chair of the department of surgery at Mayo Clinic in Florida, in a statement from Mayo.
Smith expects Mayo in Florida will do 40 procedures using the LINX system in 2012, said a Mayo spokesman in Florida via email.
“The system offers effective control of GERD with limited side effects and thus far an excellent safety record,” Smith said.
Torax Medical executives were at an off-site meeting and did not respond to calls for comment.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Here is a video of Smith explaining how the device works:
