Outline

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

• • 【Antithrombogenicity】
  • Expected a reduction of thrombosis by suppressing “platelet adhesion”, “protein adsorption” and “plasma coagulation”.
  • 【Inflammation prevention】
  • Expected a suppression of inflammation reaction by preventing “complement activation”.
  • 【Base material affinity】
  • Has adhesion and consistent coating thickness on base materials, can be applied for various medical device components.
  • 【Biologic free】
  • Is a synthetic polymer and can eliminates potential virus contamination with biologics.
  • 【Easiness】
  • Can be coated by dissolving the polymer in solvents, contacting the substrates and drying.

  

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.

Available raw materials

• ・Plasticized Polyvinyl Chloride
• ・Nylon
• ・ABS resin
• ・Polycarbonate
• ・Polyurethane
• ・Polypropylene
• ・Polyethylene
• ・Ethylene-Vinyl Acetate Copolymer
• ・Glass
• ・Stainless Steel
• ・Aluminum

Unavailable raw materials

• ・Fluorinated resins including Polytetrafluoroethylene
• ・Silicone Resin

Information

Specifications

Appearance	Transparent viscous liquid
Polymer design	・Copolymer with Polyethylene glycol acrylate, Alkyl acrylate and Polydimethyl siloxane methacrylate ・Water insoluble
Water contact angle	40-60°
Applicable sterilization method	Ethylene oxide sterilization

Biocompatibility testing

Testing	Method*	Result
Cytotoxicity	ISO10993-5*, ISO10993-5, ②	Negative
Sensitization	ISO10993-10*, ISO10993-10, ①	Negative
Acute systemic toxicity	ISO10993-11*, ISO10993-11, ①	Negative
Pyrogenicity	ISO10993-11*, ISO10993-11, ①	Negative
Hemolysis	ISO10993-4*, ISO10993-4, ①	Negative
Intracutaneous injection	ISO10993-10*, ISO10993-10, ①	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

① “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 Medical Device Review No.36, March 19, 2003
② “Revision of the Basic Principles of Biological Safety Assessment Required for Medical Device Manufacturing and Sales Approval Applications(No.1, Yakuseikishinhatsu 0106)”issued by Medical Device Evaluation and Management Division, Pharmaceutical and Food Safety Bureau, Japanese Ministry of Health, Labour and Welfare, January 6, 2020

※ Tested according to “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