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
402/28/2018UT-Heart
(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

Teijin
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.