Table 1

Sakigake assignment for medical devices

Date of designationName of productProposed indicationSponsor
1#02/10//2016Titanium Bridge
(hinge-type titanium plates)
Adduction-type spasmodic dysphoniaNobelpharma
202/28/2017Tracheal prosthesis
(made of polypropylene mesh and collagen sponge)
Aiding reconstruction of trachea while maintaining intratracheal structure after partial removalDaiichi Medical
302/28/2017Boron neutron capture therapy (BNCT) system (neutron irradiation system for BNCT)Glioblastoma, head and neck cancer (selective destruction of tumor cells marked by boron agents)Sumitomo Heavy Industries
(software to aid cardiac resynchronization therapy)
Higher accuracy prediction of effectiveness of cardiac resynchronization therapy for patients with serious heart failureUT-Heart Corporation
502/28/2018Cardiac repair patch
(combination of bioabsorbable and stretchable non-bioabsorbable synthetic polymeric threads and a bridging gelatin membrane)
 A cardiac repair patch used during cardiovascular interventions
  • Applied to correct blood flow, maintain hemoperfusion, and construct/reconstruct surrounding tissues

602/28/2018CliniMACS CD34 System
(CD34 +cell selection and isolation system)
 Product capable of facilitating synostosis
  • Administered to the site of a non-union bone fracture with collagen-containing soft-tissue injection materials as a scaffold

Miltenyi Biotec K.K.
702/28/2019Microwave mammographyIdentifies the tissues suspected of being breast cancer by microwave and provides information to the doctorIntegral Geometry Science Co.
802/28/2019Molds of vascular grafts for lower extremity arterial bypass
(in vivo tissue-engineered vascular grafts)
Improves the blood circulation failure condition below the knee by surgical reconstruction, and long-term patency of self-revascularization for patients with severe lower-limb ischemiaBiotube Co.
902/28/2019Phosphorylated pullulan bioadhesiveImproves usability and retainability for bone defects by better formativeness and adhesiveness by mixing with autologous bones, allogeneic bones, heterogeneous bones, artificial bones, or a mixture; moreover, since it has an increasing effect, it can reduce the amount of autologous bone collectedBioARC Co.
  • 1#:Titanium Bridge was approved on December 15, 2017.

  • Three requirements to apply for Sakigake designation were as follows: (1) innovative medical products for serious diseases; (2) development in Japan being world’s first or simultaneous with other countries; (3) prominent effectiveness expected on non-clinical and early phase clinical studies.