US FDA approves implant which can prevents gastric reflux (returning of gastric juice in to upper side) .
Gastroesophageal reflux disease (GERD) is caused by returning gastric fluid in to esophageal region ( gastric reflux) , gastric fluid is very corrosive and consist of hydrochloric acid which irritate and damage esophageal and gastric lining resulting in to painful wounds, heart burn and painful bleeding ulceration. If not treated can turn in to life threatening conditions.
Gastric acid return in to esophagus because the sphincter (ring like valve ) which closes lower opening of esophagus do not function properly, or closing of lower esophageal sphincter is not complete.
Now US FDA has approved an implant which has capability of closing esophageal sphincter with the magnetic force derived from placing magnetic titanium beads in to a circular ring shape which, keeps lower esophageal sphincter closed with its added magnetic force, and it opens with force from upper side when food is entering in to stomach. This helps in preventing reverse entry of gastric acid in to esophagus.
The implant is known as LINX Reflux Management System , it is a single use sterile unit which is placed surgically , and offers only alternative for surgical procedures for gastro esophageal reflux disease (GERD) . Magnetic force in titanium beads is adjusted to obtain desired force for effective closing of lower esophageal sphincter.
Patients getting LINX Reflux Management System implanted are required to undergo training for taking care after implantation of LINX Reflux Management System.
Patient implanted with LINX Reflux Management System cannot undergo Magnetic Resonance Imaging (MRI) , as metal get heated up spontaneously damaging the tissue where implant is placed.
LINX Reflux Management System is manufactured by privately held medical device company Torax Medical Inc from St. Paul, Minn USA.
Gastroesophageal reflux disease (GERD) is caused by returning gastric fluid in to esophageal region ( gastric reflux) , gastric fluid is very corrosive and consist of hydrochloric acid which irritate and damage esophageal and gastric lining resulting in to painful wounds, heart burn and painful bleeding ulceration. If not treated can turn in to life threatening conditions.
Gastric acid return in to esophagus because the sphincter (ring like valve ) which closes lower opening of esophagus do not function properly, or closing of lower esophageal sphincter is not complete.
Now US FDA has approved an implant which has capability of closing esophageal sphincter with the magnetic force derived from placing magnetic titanium beads in to a circular ring shape which, keeps lower esophageal sphincter closed with its added magnetic force, and it opens with force from upper side when food is entering in to stomach. This helps in preventing reverse entry of gastric acid in to esophagus.
The implant is known as LINX Reflux Management System , it is a single use sterile unit which is placed surgically , and offers only alternative for surgical procedures for gastro esophageal reflux disease (GERD) . Magnetic force in titanium beads is adjusted to obtain desired force for effective closing of lower esophageal sphincter.
Patients getting LINX Reflux Management System implanted are required to undergo training for taking care after implantation of LINX Reflux Management System.
Patient implanted with LINX Reflux Management System cannot undergo Magnetic Resonance Imaging (MRI) , as metal get heated up spontaneously damaging the tissue where implant is placed.
LINX Reflux Management System is manufactured by privately held medical device company Torax Medical Inc from St. Paul, Minn USA.
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1 comment:
Hellow ;
As all people who practice in the pharmaceutical manufacturing; change is inevitable.
To do this, we must have a written SOP.
I ask you if someone can help me, ginving me a model or an example.
Regards.
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