Is FibroScan FDA Approved?

FibroScan was first introduced in the European mart in 2003 , China in 2008 , Canada in 2009 , Brazil in 2010 and Japan in 2011 . Yes , FibroScan is very much US FDA ( Food and Drug Administration ) approved . It received its headway from FDA on April 5 , 2013 . It is now available in 70 + countries . The maker of FibroScan are Echosens in Paris , France .

FibroScan is a simple-minded , rapid , non - invading , reliable and painless symptomatic instrument for assessment of severity and staging of liver fibrosis in various chronic liver diseases ( fatty liver disease , hepatitis B and hepatitis C ) . It is used to measure tissue paper elastography ( tissue stiffness ) with the help of low - frequency ultrasound . Liver biopsy , which is an expensive , painful and trespassing means for the rating of fibrosis and staging , has been used historically . FibroScan , using short-lived elastography is a secure technique that takes only about 5 to 10 minutes to make out . The patient role is asked to fast for 2 to 3 hour before the procedure as there is a greater luck of increased liver awkwardness due to blood flow postprandially .

FibroScan is done by placing an sonography transducer probe between the intercostal spaces on the good liver lobe . A scurvy frequency ( 50 Hz ) mild quiver is transmitted through liver tissue , which originate an flexible shear wafture . The speed of this propagated elastic shear wafture is measured through a pulse - echo ultrasound , which like a shot correlate to tissue stiffness and liver fibrosis . In summation to fibrosis diagnosis , FibroScan is also used for sort in liver cirrhosis of the liver , non - alcoholic steatohepatitis , hepatitis C , patient at a jeopardy for hepatocellular carcinoma and monitoring patients who get hepatotoxic chemotherapy .

Is FibroScan FDA Approved?

What Are The Limitations Of FibroScan?

FibroScan that utilizes transient elastography has its own restriction . There are greater chances of failure rates and unreliable results in overweight / obese patients , children , tenuous patients in which unlike probes are used than standard probe . Liver stiffness value also differ in the cases of alanine aminotransferase elevation and acute liver inflammation . Other limitation include age , BMI , metabolic syndrome , sinusoidal over-crowding , steatosis , and supererogatory hepatic cholestasis . Like any other ultrasound based proficiency , it is highly dependent on operator .

What Is Fibrosis And Different Stages of Liver Fibrosis?

The theatrical production of liver fibrosis is imperative to appropriate treatment of liver disease patients . Staging is also useful in accost patient ’s response to different handling modalities . Liver fibrosis is excessive liver scarring due to reform-minded liver inflammation and liver cellular phone death in chronic liver disease . Liver fibrosis happens when liver tries to repair its damage cells through deposit of novel collagen fibers . This deposit of repaired tissue paper results in marred tissue or stringy tissue constitution . This exaggerated lesion healing reception interferes with normal liver part . Liver fibrosis is cause due to various affront to liver such as hepatitis B , hepatitis C , alcohol , non - alcoholic fatty liver disease , certain drug and toxin , trauma and bilious obstruction .

The scaffolding of liver fibrosis determines the degree of damage smite to the liver . The body process or the prediction of how fibrosis is progressing is base on a democratic scoring system call METAVIR scoring organisation . The activeness grade ranges from A0 to A3 : with A0 having no activeness , A1 showing mild activeness , A2 exhibit restrained activity and A3 prove serious activity .

The fibrosis staging consists of five stages fibrosis scoring organization ranging from F0 to F4 . F0 includes no evidence of fibrosis , F1 stage includes portal fibrosis without septa organisation , F2 stage has portal fibrosis along with few septum formation , F3 staging consists of various septum without any cirrhosis , and F4 staging comprise of liver fibrosis . F3 and F4 are considered the most advanced stage of liver fibrosis . Typically , FibroScan is not used for the production of exact staging ; it only distinguishes mild fibrosis from more severe fibrosis .

FibroScan is a possible option to liver biopsy as a diagnostic tool and with other serological tests it ply a workable entropy and appropriate diagnosis regarding chronic liver disease and its onward motion and has by far reduce the requirement of invasive liver biopsy , which carries with it various knottiness .

Also Read :