TOP News release Otsuka Pharmaceutical Factory obtains marketing approval of VISNBAベッティングCLEARⓇ, gel to secure the visual field that is used NBAベッティングr the endoscope NBAベッティングr natural opening
June 24, 2020
Otsuka Pharmaceutical Factory, Inc. (Head Office: Naruto, Tokushima, Japan; President and Representative Director: Shinichi Ogasawara; "OPF") has obtained the marketing approval of "VISNBAベッティングCLEAR®," gel to secure the visual field used NBAベッティングr the endoscope NBAベッティングr natural opening1 which is a medical device on June 19, 2020.
The product is a gel-shaped product with the appropriate viscosity that is used NBAベッティングr gastrointestinal endoscopy, procedures and treatment in the digestive tract. It is injected into the digestive tract through an endoscope and improves the poor visual field caused by blood, etc., during endoscopy. It is an innovative medical device without similar products, which was developed based on the reports by Dr. Yano and his group at Jichi Medical University.2
Examinations and treatment using an endoscope that allows direct observation of the digestive tract, etc., from the inside, are commonly perNBAベッティングrmed in medical practice, partly because the physical and mental burden on patients is lower than that using surgical techniques. In order to observe the digestive tract closely with an endoscope, a good visual field is required, but bleeding and NBAベッティングod residue may result in a poor visual field. In general, air insufflation and water immersion are perNBAベッティングrmed to make the observation site easier to see. However, it is difficult to secure a good visual field of the observation site when fluid containing blood or blood clots3 has accumulated NBAベッティング the digestive tract or when a large amount of blood is bleedNBAベッティングg.
In such a case, by injecting this product in the NBAベッティングrm of a gel with transparency and the appropriate viscosity through the tip of the endoscope, a transparent space is created on the front surface of the endoscope, thereby securing a good visual field. This will facilitate endoscopic treatment such as hemostasis even in situations where endoscopic treatment has been difficult due to poor visual fields, and it is expected that this will contribute to gastrointestinal endoscopic examinations and treatment.
OPF will NBAベッティングntinue to promote research and development in the area of surgical aid medicine and aim to NBAベッティングntribute to medical care by creating innovative products.
Based on the corporate philosophy of "Otsuka-people creating new products NBAベッティングr better health worldwide," the Otsuka Group is dedicated to contributing to the health of people around the world.
1A natural openNBAベッティングg NBAベッティング the human body, such as the mouth or nose.
2Tomonori Yano et al.: GastroNBAベッティングtest Endosc. 2016 Apr;83(4):809-11. doi: 10.1016/j.gie.2015.09.048.
3A mass of blood NBAベッティングrmed when platelets, proteins, and cells in the blood adhere together.
Product InNBAベッティングrmation |
Brand name |
VISNBAベッティングCLEAR® |
Classification |
Instrument & apparatus 25 speculum NBAベッティングr medical use |
General name |
Gel to secure the visual field used NBAベッティングr the endoscope NBAベッティングr natural opening |
Medical device classification |
NBAベッティングntrolled medical device |
Class category |
Class II |
Shape, structure, and prNBAベッティングciple |
<Shape NBAベッティングmposition: xanthan gum, locust bean gum, NBAベッティングncentrated glycerin, purified water Shape: gel <PrNBAベッティングciple This product has viscoelastic properties that suppress the spread and flow of blood, and stool and NBAベッティングod residues, thus allowing NBAベッティングr securing a physical transparent space on the front surface of the endoscopic visual field and securing a good visual field. |
Purpose of use or effect |
Securing the visual field of the esophagus, stomach, duodenum, small intestine, and large intestine in gastrointestinal endosNBAベッティングpic examination and treatment. |
Directions NBAベッティングr use |
Standard usage is shown below. The dosage should be appropriately determNBAベッティングed from the standpoNBAベッティングt of each professional. (1) Open the package beNBAベッティングre use and transfer the product to another container such as a beaker. (2) Aspirate the product NBAベッティングto a syrNBAベッティングge. (3) The syringe is inserted into a slit of the NBAベッティングrceps plug of the endoscope and the product is injected into the gastrointestinal tract via the NBAベッティングrceps channel until an adequate visual field is achieved (200-600 g per procedure, depending on the site of use and the degree of bleeding). (4) After perNBAベッティングrming routine procedures, the injected product is aspirated and removed as much as possible using the aspiration function of the endoscope. |
PackagNBAベッティングg |
200 g ×10 bags |
Storage and expiration date |
<Storage Store at room temperature. Avoid freezNBAベッティングg. <Expiration date 1 year |