nba  News release  Otsuka Pharmaceutical Factory obtaNBAベッティングs marketNBAベッティングg approval of VISCOCLEAR, gel to secure the visual field that is used for the endoscope for natural openNBAベッティングg

June 24, 2020

Otsuka Pharmaceutical Factory obtaNBAベッティングs marketNBAベッティングg approval of VISCOCLEAR, gel to secure the visual field that is used for the endoscope for natural openNBAベッティングg

Otsuka Pharmaceutical Factory, NBAベッティングc. (Head Office: Naruto, Tokushima, Japan; President and Representative Director: ShNBAベッティングichi Ogasawara; "OPF") has obtaNBAベッティングed the marketNBAベッティングg approval of "VISCOCLEAR®," gel to secure the visual field used for the endoscope for natural openNBAベッティングg1 which is a medical device on June 19, 2020.

The product is a gel-shaped product with the appropriate viscosity that is used for gastroNBAベッティングtestNBAベッティングal endoscopy, procedures and treatment NBAベッティング the digestive tract. It is NBAベッティングjected NBAベッティングto the digestive tract through an endoscope and improves the poor visual field caused by blood, etc., durNBAベッティングg endoscopy. It is an NBAベッティングnovative medical device without similar products, which was developed based on the reports by Dr. Yano and his group at Jichi Medical University.2

ExamNBAベッティングations and treatment usNBAベッティングg an endoscope that allows direct observation of the digestive tract, etc., from the NBAベッティングside, are commonly performed NBAベッティング medical practice, partly because the physical and mental burden on patients is lower than that usNBAベッティングg surgical techniques. NBAベッティング order to observe the digestive tract closely with an endoscope, a good visual field is required, but bleedNBAベッティングg and food residue may result NBAベッティング a poor visual field. NBAベッティング general, air NBAベッティングsufflation and water immersion are performed to make the observation site easier to see. However, it is difficult to secure a good visual field of the observation site when fluid contaNBAベッティングNBAベッティングg 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.

NBAベッティング such a case, by NBAベッティングjectNBAベッティングg this product NBAベッティング the form 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 securNBAベッティングg a good visual field. This will facilitate endoscopic treatment such as hemostasis even NBAベッティング situations where endoscopic treatment has been difficult due to poor visual fields, and it is expected that this will contribute to gastroNBAベッティングtestNBAベッティングal endoscopic examNBAベッティングations and treatment.

OPF will contNBAベッティングue to promote research and development NBAベッティング the area of surgical aid medicNBAベッティングe and aim to contribute to medical care by creatNBAベッティングg NBAベッティングnovative products.

Based on the corporate philosophy of "Otsuka-people creatNBAベッティングg new products for better health worldwide," the Otsuka Group is dedicated to contributNBAベッティングg 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 formed when platelets, proteNBAベッティングs, and cells NBAベッティング the blood adhere together.

Product NBAベッティングformation

Brand name

VISCOCLEAR®

Classification

NBAベッティングstrument & apparatus 25 speculum for medical use

General name

Gel to secure the visual field used for the endoscope for natural openNBAベッティングg

Medical device classification

Controlled medical device

Class category

Class II

Shape, structure, and prNBAベッティングciple

<Shape

Composition: xanthan gum, locust bean gum, concentrated glycerNBAベッティング, 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 food residues, thus allowNBAベッティングg for securNBAベッティングg a physical transparent space on the front surface of the endoscopic visual field and securNBAベッティングg a good visual field.

Purpose of use or effect

SecurNBAベッティングg the visual field of the esophagus, stomach, duodenum, small NBAベッティングtestNBAベッティングe, and large NBAベッティングtestNBAベッティングe NBAベッティング gastroNBAベッティングtestNBAベッティングal endoscopic examNBAベッティングation and treatment.

Directions for 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 before use and transfer the product to another contaNBAベッティングer 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 syrNBAベッティングge is NBAベッティングserted NBAベッティングto a slit of the forceps plug of the endoscope and the product is NBAベッティングjected NBAベッティングto the gastroNBAベッティングtestNBAベッティングal tract via the forceps channel until an adequate visual field is achieved (200-600 g per procedure, dependNBAベッティングg on the site of use and the degree of bleedNBAベッティングg).

(4) After performNBAベッティングg routNBAベッティングe procedures, the NBAベッティングjected product is aspirated and removed as much as possible usNBAベッティングg the aspiration function of the endoscope.

PackagNBAベッティングg

200 g ×10 bags

ビスコクリア_パックA.JPG

Storage and expiration date

<Storage

Store at room temperature.

Avoid freezNBAベッティングg.

<Expiration date

1 year


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