LINX ® is a small, flexible ring placed around the lower esophagus, right above the opening to the stomach. You are about to leave jnjmedicaldevices.com. 5 Long-term outcomes are known for both anterior and posterior partial fundoplication variants, with success rates of more than 85 percent at 10 to 20 years follow-up reported in randomized trials. Weight gain can sometimes cause problems with the Linx device because it puts pressure on the stomach. Other risks reported after anti-reflux surgery procedures include bloating, nausea, dysphagia (difficulty swallowing), odynophagia (painful swallowing), retching, and vomiting. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who … Indications, safety, and warnings for the Reveal LINQ implantable cardiac monitoring system. Potential risks associated specifically with the LINX Reflux Management System include achalasia (lower part of esophagus does not relax), bleeding, cough, death, decreased appetite, device erosion, device explant/re-operation, device failure, device migration (device does not appear to be at implant site), diarrhea, dyspepsia (indigestion), dysphagia (difficulty swallowing), early satiety (feeling full after eating a small amount of food), esophageal spasms, esophageal stricture, flatulence, food impaction, globus sensation (sensation of a lump in the throat), hiccups, inability to belch or vomit, increased belching, infection, impaired gastric motility, injury to the esophagus, spleen, or stomach, nausea, odynophagia (painful swallowing), organ damage caused by device migration, pain, peritonitis (inflammation of the peritoneum), pneumothorax (collapsed lung), regurgitation, saliva/mucus build-up, stomach bloating, ulcer, vomiting, weight loss, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn). 14(5):671-7. © Ethicon US, LLC. Morbid obesity. Displaying 1 - 2 of 2. Warnings: The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T), depending on the LINX model implanted. Maximum spatial gradient of the static magnetic field specification must be ≤25 T/m (2500 gauss/ cm). The company's modules, remote controls, evaluation kits and master development systems feature straightforward hardware configuration and clear documentation. If you are a patient, it is important that you discuss information about the benefits and risks of products with your doctor. This site uses cookies as described in our, LINX Reflux Management System Dr John Pandolfino reviews CALIBER Video, The LINX Reflux Management System Procedure - Dr. Blair A. Jobe, MD, The LINX Reflux Management System Tissue Encapsulation, The LINX Reflux Management System Short Procedure, The LINX Reflux Management System Yield Pressure, Dr John Lipham Reviews LINX outcomes in Patients with Large Hiatal Hernias. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients. The strength of the magnets helps keep the LES closed to prevent reflux. Prior esophageal or gastric surgery or endoscopic intervention. Company Name: Torax Medical, Inc.. See a short video on how LINX ® works. Diagnostic Imaging with LINX ®. Can I have an MRI test after receiving the LINX Reflux Management System? (p<0.001), ¶ Ganz R. Edmundowicz S, Taiganides P, et al. MODEL SPECS. Dr. Michael Harrison (pediatric surgery UCSF) is currently running a phase 2 research procedure, The Magnetic Mini-Mover procedure. A replacement linx was implanted (model: lxmc15, lot: 21340). Device explant due to the device opening occurred without issue on (b)(6) 2018. Safety Info ID# Safety Topic / Subject Article Text 351: LINX Reflux Management System (Torax Medical, Inc., www.toraxmedical.com) LINX Reflux Management System. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, there was a significant improvement in the median GERD-HRQL score at 5 years, as compared with  baseline, both with and without PPI use, 4 vs 11 and 27 respectively (p<0.001). Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. LINX® patients may undergo magnetic resonance imaging (MRI) up to either 0.7 – Tesla (0.7T) or 1.5 – Tesla (1.5T) depending on the LINX® model implanted. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. 2019. (p<0.001), § Ganz R. Edmundowicz S, Taiganides P, et al. ‡‡ Reynolds J, Zehetner J, Wu P, et al. Symptoms of dysphagia more than once per week within the last 3 months. 14(5):671-7. Instructions for use are found in the information that accompanied the product packaging. Failure to secure the LINX device properly may result in its subsequent displacement and necessitate a second operation. 2016. proton pump inhibitors or equivalent) in the management of their GERD. Since the LINX system contains magnetic metals, there is a good chance that you’ll experience serious internal injuries if you go in for an MRI. 84 subjects were followed up for 5 years, baseline dissatisfaction was 95% and decreased to 7.1% in year 5 (p < .001). Based on a retrospective analysis of 1-year outcomes of patients undergoing MSA and LNF from June 2010 to June 2013. † Based on 192 patients who underwent MSA with LINX as well as a matched pair analysis in which 47 patients underwent MSA2. Alert Indications, Safety, ... Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library. This information is intended for use by customers, patients, and healthcare professionals in the United States only. In addition, the magnetic field produced by an MRI machine could interfere with the magnetic bonds in the beads, rendering them ineffective. For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert. MRI Absolute Contraindications . (BMI >35) Data and usage fees may apply. All Rights Reserved. 221(1):123-128. The safety and effectiveness of the LINX device has not been evaluated in patients with electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants. It is recommended that patients receiving the LINX device register their implant with the MedicAlert Foundation (www.medicalert.org) or equivalent organization. Based on the GERD-HRQL. The procedure usually takes less than one hour to perform. Reveal LINQ™ Insertable Cardiac Monitor MRI Conditions for Use. Close Cookie Statement . Floor polishers are poor MRI system cleaners! This site uses cookies to store information on your computer. Failure to follow these conditions for use may result in a hazard to the patient during an MRI scan: Hydrogen proton MRI equipment must have a static magnetic field of 1.5 Tesla (T) or 3.0 T. Safety Topic / Subject ActiFlo Indwelling Bowel Catheter System also known as Zassi Bowel Management System Hollister Incorporated Libertyville, IL. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, regurgitation was 57% at baseline and decreased to 1.2% at 5 years. Go ahead, let it out. The Epic stented tissue valve with Linx™ anticalcification (AC) technology is engineered to deliver excellent durability and performance, as well as smooth, streamlined implantability. The use of the LINX device in patients with a hiatal hernia larger than 3cm should include hiatal hernia repair to reduce the hernia to less than 3cm. When patients swallow, the LINX Reflux Management System opens temporarily to allow food and liquid to pass into the stomach. Suspected or confirmed esophageal or gastric cancer. MR Conditional Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No Device labeled as "Not made with natural rubber latex": No For Single-Use: Yes Prescription Use (Rx): Yes Over the Counter (OTC): € Ganz R. Edmundowicz S, Taiganides P, et al. ** Ganz R. Edmundowicz S, Taiganides P, et al. 360° Retained ability to belch and vomit 13. Dimensions. * The LINX Reflux Management System is a flexible ring of small magnets placed around the LES during a minimally invasive procedure. With the lowest overall ventricular protrusion in all valve sizes, 1-5 the Epic Mitral valve is an excellent choice for the mitral position. 4.3% of MSA patients were unable to vomit when necessary compared to 21.3% of LNF patients (p = 0.004). The LINX System is placed around the esophagus and the ends of the device are attached to each other. 1.2 cc. J American College of Surgeons. Implantable Pediatric Sternum Device. Based on a retrospective analysis of 1-year outcomes of patients undergoing MSA and LNF from June 2010 to June 2013. Contraindications: Do not implant the LINX Reflux Management System in patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials. Requires no permanent anatomic alteration to restore the reflux barrier. The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus or Grade C or D (LA classification) esophagitis. (p<0.001). Welcome to Linx Support. The LINX Reflux Management System a . This site is intended for Healthcare Professionals. Q. Version (Model) Number: LXMC15. Product Code LXM-13; b. Esophagram on (b)(6) 2018 visualized the discontinuous device. Potential Side Effects: Potential adverse events associated with laparoscopic surgery and anesthesia include adverse reaction to anesthesia (headache, muscle pain, nausea), anaphylaxis (severe allergic reaction), cardiac arrest, death, diarrhea, fever, hypotension (low blood pressure), hypoxemia (low oxygen levels in the blood), infection, myocardial infarction, perforation, pneumonia, pulmonary embolism (blood clot in the lung), respiratory distress, and thrombophlebitis (blood clot). Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. ‡ Based on a 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. Distal esophageal motility less than 35mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or High Resolution Manometry equivalent, and/or a known motility disorder such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES. 1,2,3 The longevity of LINX will remain uncertain for at least another five to 10 years. For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Please visit linxforlife.com for additional information. Clin Gastroenterol Hepatol. ** Achieved target reduction in GERD-HRQL score in 83% of patients, and target reduction in PPI usage in 89% of patients.†† Improvement in patient satisfaction at 5 years.€ The device maintains normal gastroesophageal junction and gastric anatomy and preserves physiologic function (belch and vomit).‡‡ Low incidence of side effects.§§, FENIX Product Discontinuation Information. Some are essential to make our site work; others help us improve the user experience. 360° Restore, don't reconstruct 12. A replacement linx device was implanted at the time (model: lxmc15, lot: 16734). The company started implanting LINX units safe to 1.5T after that date, and those implant cards are blue in color. Based on a study observing 100 patients who were implanted with LINX, daily use of PPIs  decreased to 15.3% at 5 years. Indications, Safety & Warnings; Clinician Education Clinical Evidence Resources and Support ... Horizontal cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) or 3.0 T must be used. Working as one Limb, Linx delivers an experience that mimics the incredible and complex structure of the human leg by actively sensing and analyzing data on the user movement, activity, environment and terrain providing a coordinated stream of instructions to the hydraulic support system. Bothersome heartburn was 89% at baseline and decreased to 11.9% at 5 years(p<0.001), bothersome regurgitation was 57% at baseline and decreased to 1.2% at 5 years (p<0.001), PPI dependence decreased to 15.3% at 5 years (p<0.001). You should discuss the MRI scanning options with your doctor prior to deciding on treatment with the LINX® system. Search by the product name (Reveal LINQ) or model number (LNQ11). In a study of 100 patients implanted with LINX, bothersome heartburn decreased to 11.9% (p<0.001) and bothersome regurgitation decreased to 1.2% (p<0.001). A steel oxygen tank is never permitted inside of the MRI system room. For product support, downloads and technical information for the Linx range of tablets and notebooks, please select your device from the choices below. Unlike other procedures to treat reflux, LINX is implanted around the outside of the Lower Oesophageal Sphincter (LOS) and requires no alteration to the stomach. A version of LINX ® considered MR Conditional in a magnetic resonance imaging (MRI) system up to 1.5 Tesla (1.5T) is now available. Shoreview, Minnesota 55126, USA. Patients with a LINX ® device can safely undergo a wide range of diagnostic imaging tests, including: X-Ray, ultrasound, PET scan, CT scan and MRI.. Are you considering LINX ®?. Anti-reflux procedure including linx device implantation occurred on (b)(6) 2015. Under general anesthesia, a surgeon who has experience in laparoscopic anti-reflux procedures and has received specific training in the use of the LINX device will access the esophagus using a laparoscopic approach (through several small incisions made in the abdomen). Clin Gastroenterol Hepatol. You should discuss the MRI scanning options with your physician prior to deciding on treatment with LINX®. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies. With LINX ®, acid stays in the stomach, where it belongs. Matched-pair analysis of 100 patients. LINX® patients can also undergo: CT Scan, Ultrasound, X-Ray and PET Scan. Global Unique Device ID: 00855106005356. §§ Reynolds J, Zehetner J, Wu P, et al. LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Gastroesophageal Reflux Disease (GERD) is a chronic, often progressive disease resulting from a weak lower esophageal sphincter (LES). I should point out that the LINX devices implanted before May 22, 2015 were MRI safe up to 0.7T. 98.1% (p=0.118) and 97.8% of patients, respectively, reported symptom improvement or resolution. Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. General Precautions: The LINX device is a long-term implant. 8.5% of MSA patients were unable to belch, compared to 25.5% of LNF patients (p = 0.028). Hardbound MRI Textbook. LINX® Reflux Management System Important Safety Information. Linx products make it simple for engineers and hobbyists to integrate wireless features without the hassle and expense of engineering RF functionality from scratch. The LINX Reflux Management System a, LINX Reflux Management System Implant LINX System Torax Medical, www.toraxmedical.com IMPORTANT NOTE: It's important to know which LINX device a patient has prior to MRI. Early LINX data does not appear to match these outcomes. Labeled as: a. Management of adverse reactions may include explantation and/or replacement. 2015. Reveal LINQ LNQ11 Specifications. Last updated February 20, 2019. There was no evidence of a hiatal hernia, gastro esophageal reflux, or esophagitis at the time. Patient began experiencing gerd. The LINX® Reflux Management System (Torax Medical, Inc., Shoreview, MN, USA) is comprised of a small expandable ring of linked magnetic beads. There are two versions of the LINX® device. It keeps harmful stomach acid from flowing back up into the esophagus, where it can cause painful heartburn and damage. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. A Revolutionary Treatment for Reflux Disease. One is safe in MRI scanning machines up to 0.7T, the other is safe to 1.5T. Matched-pair analysis of 100 patients. Demonstrated efficacy with a favourable safety profile 11. Those patients have a white implant device card. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than forty internationally respected experts in the field. 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