Evidence map›Paper›PMID 41085780›Full record

ArticleJournal of materials science. Materials in medicine2025

Evaluation of nickel release from Ni-Ti stents in various media for safety assessment purposes.

Bin Liu, Yafan Hu, Kai Xu, Bo Zhang, Dong Liu, Changyan Wu, Xiuyun Han, Peng Han, Jian Lu, Naishui Han

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of materials science. Materials in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Bin LiuShandong Institute of Medical Device and Pharmaceutical Packaging Inspection/NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices/Shandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, China. 31565389@qq.com.
Yafan HuInstitute of Food Science and Technology, Chinese Academy of Agricultural Sciences/Key Laboratory of Agro-products Quality and Safety Control in Storage and Transport Process, Ministry of Agriculture, Beijing, China.
Kai XuShandong Institute of Medical Device and Pharmaceutical Packaging Inspection/NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices/Shandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, China.
Bo ZhangShandong Institute of Medical Device and Pharmaceutical Packaging Inspection/NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices/Shandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, China.
Dong LiuShandong Institute of Medical Device and Pharmaceutical Packaging Inspection/NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices/Shandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, China.
Changyan WuShandong Institute of Medical Device and Pharmaceutical Packaging Inspection/NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices/Shandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, China.
Xiuyun HanAmhwa Biopharm Co. Ltd, Binzhou, China.
Peng HanAmhwa Biopharm Co. Ltd, Binzhou, China.
Jian LuShandong Institute of Medical Device and Pharmaceutical Packaging Inspection/NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices/Shandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, China.
Naishui HanShandong Institute of Medical Device and Pharmaceutical Packaging Inspection/NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices/Shandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nickel (Ni) was an essential component of Ni-Ti alloys used in cardiovascular implants. However, the release of Ni from these alloys might pose potential health risks. This study aimed to identify a simple extraction medium for evaluating Ni release from Ni-Ti alloys and to establish safety assessment guidelines. Seven extraction media, including 0.005% HCl and goat whole blood, were tested. The Ni release was analyzed using inductively coupled plasma atomic emission spectroscopy (ICP-AES) and statistical methods. The results indicated that 0.005% HCl could replace goat blood, as it showed comparable Ni release levels and provided a more conservative assessment. The optimal extraction medium was validated over 41 days at 37 °C. The Ni release curves demonstrated higher release in 0.005% HCl than in physiological media. Safety evaluation against the International Council for Harmonisation's (ICH) permissible daily exposure (PDE) of 20 μg/day revealed that some samples exceeded the limits, highlighting the need for stringent risk assessment. This study provided a practical method for Ni release evaluation, supporting regulatory oversight and enhancing product safety in the medical device industry.

Indexed as

NickelStentsTitaniumAlloysAnimalsGoatsHumansMaterials TestingRisk AssessmentSpectrophotometry, AtomicAlloysNickelTitaniumtitanium nickelide

Identifiers

PMID41085780
PMCPMC12521320

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.