Regulatory approval review of transcatheter mitral valve repair – Difference in the indication between the USA and Japan

Konishi, Akihide; Ho, Mami; Ouchi, Takashi; Mitsutake, Yoshiaki; Shirato, Haruki

doi:10.1016/j.jjcc.2019.03.013

Cited by 4 publications

(1 citation statement)

References 19 publications

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“…The Use-Result Survey System is part of a strategy to expedite patients' access to innovative medical devices and to accelerate the development of new medical devices while reducing the premarket regulatory burden of clinical trials and enhancing post-marketing commitments of medical device regulations over a product's life cycle (19,20).…”

Section: Discussionmentioning

confidence: 99%

Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold-

Konishi

Mitsutake

et al. 2021

Intern. Med.

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Although a domestic trial in Japan revealed that Absorb bioresorbable vascular scaffold (BVS) has no inferiority to everolimus-eluting stent (EES) cohort in the primary endpoint of the target lesion failure at 12 months, the scaffold/stent thrombosis (ST) rates with the BVS at 24 months were higher than those with the EES (Absorb BVS 3.1% vs. EES 1.5%), the ST rate of 3.1% with Absorb BVS is not an acceptable level in Japan. A cause-of-ST analysis revealed that cases in which diagnostic imaging and ensuing post-dilatation had been performed appropriately had lower ST rates than those without such management (within 1 year: 1.37% vs. 7.69%, from 1 to 2 years: 0.00% vs. 8.33%). Therefore, a further evaluation was needed to confirm that the ST rate with the Absorb BVS would be reduced by a proper implementation procedure. Regulatory approval was given conditionally to initiate rigorous post-marketing data collection in order to ensure the proper use of this device in limited facilities. The One-year Use-Result Survey in Japan for the Absorb BVS revealed no instances of ST. This approach to reducing the premarket regulatory burden of clinical trials and enhancing the post-marketing commitments of medical device regulation is useful for expediting patient access to innovative medical devices.

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Section: Discussionmentioning

confidence: 99%