Launch the New type Surgical Hemostatic Agent made by non biological materials independent on the patients blood coagulation ability.
- 2014/01/30 News
Sanyo Chemical obtained the approval of the medical device under the Pharmaceutical Affairs Law on Dec. 20 in 2011 as the new type surgical hemostatic agent which is used for anastomosing the arterial blood and artificial blood vessel in the surgical operation. This instrument will go into production by Sanyo and sales by Terumo, a medical-device manufacturer, as a pet name “Hydrofit” to medical institutions in Japan from Feb. 4 in 2014. For your information, this product is the first medical device for us.
Date of approval under the Pharmaceutical Affairs Law : Dec. 20 in 2011
Approval No. of the medical device : 22300BZX00467000
Brand name : Matsudaito (Pet name :Hydrofit)
Generic name : Non-absorbable topical hemostatic material for central circulatory system
Insurance coverage : Anastomosis* site by the artificial blood vessel in thoracic aorta and / or branching artery of aortic arch
*one procedure in surgical operation to sew and connect the blood vessels
[General surgical hemostatic agent and Sanyo’s one] Surgical hemostatic agent is used by coating over the anastomosis site to help hemostatic action in the surgical treatment. Fibrin glue provided from blood of human beings or animals is widely used for this purpose. Enough blood stop performance may not be obtained when the patient’s blood coagulation ability decreases because that performance of the fibrin glue depends on the patient’s blood coagulation ability.
Sanyo has developed the new type surgical hemostatic agent made by non biological materials independent on the patient’s blood coagulation ability. This is the synthetic hemostatic agent based on urethane technology which is one of our core technologies. High hemostatic property will be expected because reactive isocyanate groups, whereof the both ends of fluorine containing polyether polyurethane prepolymer (an intermediate being stopped the polymerization at the optimal state) in the syringe, react with the water existing on the surface of a living tissue of the patient and form the curing film having superior tissue adhesiveness in a few minutes.
[Features of Hydrofit] 1. High hemostatic property will be expected because the reaction progresses using the water on the living tissue of the patient and the curing film having superior tissue adhesiveness is formed in a few minutes. It is independent on the patient’s blood coagulation ability.
2. Curing film has the flexibility following the living tissue movement such as pulsation.
3. Reduction in the risk of virus infection will be expected because this product is a synthetic hemostatic agent without using the materials from human beings or animals.