Outline

SEC ONE SURFACE_TM is a biocompatible polymer, which can introduce antithrombogenicity on medical devices that contact human organs or vessels.

• • 【Antithrombogenicity】
  • ・ Reduces platelet adhesion and then thrombogenicity
  • ・ Reduces plasma proteins in coagulation system and then thrombogenicity
  • ・ Prolongs blood coagulation without anticoagulants
  • 【Inflammation prevention】
  • ・ Reduces activations of complement as immune system proteins as a result of foreign body recognitions
  • 【Base material affinity】
  • ・ Can be applied on polyurethane and plasticized polyvinyl chloride as medical device components
  • 【Biologic free】
  • ・ Is a synthetic polymer and can eliminates potential virus contamination with biologics

  

Three units on SEC ONE SURFACE_TM contribute to its biocompatibility.

When medical device surface contacts blood, three systems, complement, platelet and coagulation systems are activated by foreign body recognition. After the complement system activation, C3a is generated and leads to inflammation.
After platelet system and coagulation systems activations, they lead to blood clot by platelet adhesion and plasma coagulation.

The 3 units on SEC ONE SURFACE_TM can prevent foreign body recognitions when contact with blood.

• Feature
• Information

Feature Information

Feature

Antithrombogenicity

Hydrophilic unit reduces platelet adhesion, blood clot formation and microbes attachment.

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Inflammation prevention

Water repellent unit reduces complement activation.

Base material affinity

Hydrophobic unit enhances the adhesiveness and consistent coating thickness on base materials and reduces the polymer elution.

Information

Specifications

Appearance	Transparent viscous liquid
Polymer design	・Copolymer with Polyethylene glycol acrylate, Alkyl acrylate and Polydimethyl siloxane methacrylate ・Water insoluble
Water contact angle	Approximately 50°
Sterilized by	Ethylene oxide (ETO)
Application to medical device	Intravascular catheter1), Cardiopulmonary bypass circuit component2)

1) Yuta Takezawa et al.: in vivo, 33, 877-880 (2019)
2) Tomomi Hasegawa et al: Perfusion, 35(8), 826-832 (2020)

Biocompatibility testing

Testing	Method	Result
Cytotoxicity	ISO10993-5*, **	Negative
Sensitization	ISO10993-10*, **	Negative
Acute systemic toxicity	ISO10993-11*, **	Negative
Pyrogenicity	ISO10993-11*, **	Negative
Hemolysis	ISO10993-4*, **	Negative
Intracutaneous injection	ISO10993-10*, **	Negative
Reverse mutation	ISO10993-3*	Negative
Chromosomal aberration	ISO10993-3*	Negative
Implantation for 2 and 4 weeks	ISO10993-6*	Negative
Subchronic toxicity for 28-day continuous venous administration	ISO10993-11*	Negative

* “Guidance for Specific Biological Tests Relevant to the Principles Issued by the Notification Iyakushinhatsu No. 0213001”, Pharmaceutical and Food Safety Bureau, Japanese Ministry of Health, Labour and Welfare, Memorandum Iryokiki-shinsa No. 36, March 19, 2003

** “Good Laboratory Practice Standard Ordinance for Nonclinical Laboratory Studies on Safety of Medical Devices”, Japanese Ministry of Health, Labour and Welfare, Ordinance No. 37, March 23, 2005