Researchers examine the challenges of ensuring the safety of cardiovascular devices

2004 ◽  
Keyword(s):  
Cardiovascular Devices

scholarly journals A review of the bio-tribology of medical devices

Friction ◽  
2021 ◽  
Author(s):  
Xiaogang Zhang ◽  
Yali Zhang ◽  
Zhongmin Jin
Keyword(s):  
Service Life ◽  
Medical Devices ◽  
Tribological Behavior ◽  
Tribological Performance ◽  
Dental Restoration ◽  
Surgical Instruments ◽  
Cardiovascular Devices ◽  
Artificial Joints ◽  
Future Developments ◽  
Fixation Devices

AbstractNumerous medical devices have been applied for the treatment or alleviation of various diseases. Tribological issues widely exist in those medical devices and play vital roles in determining their performance and service life. In this review, the bio-tribological issues involved in commonly used medical devices are identified, including artificial joints, fracture fixation devices, skin-related devices, dental restoration devices, cardiovascular devices, and surgical instruments. The current understanding of the bio-tribological behavior and mechanism involved in those devices is summarized. Recent advances in the improvement of tribological properties are examined. Challenges and future developments for the prospective of bio-tribological performance are highlighted.

scholarly journals Venous and Arterial Endothelial Cells from Human Umbilical Cords: Potential Cell Sources for Cardiovascular Research

2021 ◽  
Vol 22 (2) ◽  
pp. 978
Author(s):  
Skadi Lau ◽  
Manfred Gossen ◽  
Andreas Lendlein ◽  
Friedrich Jung
Keyword(s):  
Endothelial Cells ◽  
Umbilical Cord ◽  
Membrane Integrity ◽  
Cell Types ◽  
Cell Number ◽  
Human Umbilical Cord ◽  
Cardiovascular Research ◽  
Cardiovascular Devices ◽  
Arterial Endothelial Cells

Although cardiovascular devices are mostly implanted in arteries or to replace arteries, in vitro studies on implant endothelialization are commonly performed with human umbilical cord-derived venous endothelial cells (HUVEC). In light of considerable differences, both morphologically and functionally, between arterial and venous endothelial cells, we here compare HUVEC and human umbilical cord-derived arterial endothelial cells (HUAEC) regarding their equivalence as an endothelial cell in vitro model for cardiovascular research. No differences were found in either for the tested parameters. The metabolic activity and lactate dehydrogenase, an indicator for the membrane integrity, slightly decreased over seven days of cultivation upon normalization to the cell number. The amount of secreted nitrite and nitrate, as well as prostacyclin per cell, also decreased slightly over time. Thromboxane B2 was secreted in constant amounts per cell at all time points. The Von Willebrand factor remained mainly intracellularly up to seven days of cultivation. In contrast, collagen and laminin were secreted into the extracellular space with increasing cell density. Based on these results one might argue that both cell types are equally suited for cardiovascular research. However, future studies should investigate further cell functionalities, and whether arterial endothelial cells from implantation-relevant areas, such as coronary arteries in the heart, are superior to umbilical cord-derived endothelial cells.

Differences in clotting parameters between species for preclinical large animal studies of cardiovascular devices

2017 ◽  
Vol 21 (2) ◽  
pp. 138-141 ◽  
Author(s):  
Toshihide Mizuno ◽  
Tomonori Tsukiya ◽  
Yoshiaki Takewa ◽  
Eisuke Tatsumi
Keyword(s):  
Animal Studies ◽  
Large Animal ◽  
Cardiovascular Devices

Abstract 17056: Food and Drug Administration Mandated Post-Market Studies for High Risk Cardiovascular Devices Approved 2015-2019

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Danelle Hidano ◽  
Sanket Dhruva ◽  
Rita F Redberg
Keyword(s):  
High Risk ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Included Study ◽  
Life Cycle Approach ◽  
Cardiovascular Devices ◽  
Study Duration ◽  
Number Of Patients ◽  
Data Elements ◽  
Double Blinded

Introduction: The Food and Drug Administration (FDA) emphasizes a “life-cycle approach” to medical device regulation, in which the pre-approval process is expedited and more emphasis is placed on post-approval data in order to shorten patient access to new devices. The FDA can mandate post approval studies (PASs) for high-risk devices to augment pre-approval data. This study describes the characteristics of FDA-mandated PASs. Methods: We searched the FDA database for all PASs required for original high-risk cardiovascular devices approved from January 1, 2015 and December 31, 2019. Data elements abstracted for each PAS included: study type, presence of controls, blinding, total number of patients enrolled, study duration, and whether primary outcomes were surrogate or composite measures. We also checked the FDA website for any available interim data prior to study completion. Results: The FDA approved 71 high-risk cardiovascular devices and ordered a total of 68 PASs for 49 (69%) devices. Most PASs were prospective cohorts (n=47, 69.1%). The median study size was 250 patients (IQR 151-563) and median study duration was 5 years (IQR 3-5). Only 19 studies (28%) included active or historic controls, 12 studies (17.7%) were randomized, 5 studies (7.3%) were single-blinded, and none were double-blinded (Table). Twenty-two (32.4%) studies provided data before completion of study. Conclusion: Most PAS are not randomized, lack controls, contain small numbers of patients, and have composite or surrogate primary outcomes that may not be clinically relevant, despite their importance for generating long-term clinical data for high-risk cardiovascular devices. Interim data are often not available. Increased quality and availability of evidence related to PASs would better establish device safety, effectiveness, and appropriate use. Lastly, PAS data should be readily accessible to help clinicians and patients make well-informed decisions.

scholarly journals A Review of Integrin-Mediated Endothelial Cell Phenotype in the Design of Cardiovascular Devices

2018 ◽  
Vol 47 (2) ◽  
pp. 366-380 ◽  
Author(s):  
Allison Post ◽  
Ellen Wang ◽  
Elizabeth Cosgriff-Hernandez
Keyword(s):  
Endothelial Cell ◽  
Cell Phenotype ◽  
Cardiovascular Devices

Abstract 140: Majority of High-Risk Cardiovascular Device Studies Do Not Include Comparative Efficacy Data at the Time of FDA Approval

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Connie E Chen ◽  
Rita F Redberg ◽  
Sanket S Dhruva
Keyword(s):  
High Risk ◽  
Active Control ◽  
Comparative Efficacy ◽  
Efficacy Data ◽  
Cardiovascular Devices ◽  
Fda Approval ◽  
Objective Performance ◽  
Active Controls ◽  
Historical Controls ◽  
Effectiveness Data

Introduction Comparative effectiveness data is important in informing regulatory and treatment decisions with information on the clinical significance of the measured outcomes. There is increasing utilization and significance of cardiovascular devices in the United States, thus it is important to know the comparative efficacy of novel cardiovascular devices at the time they receive Food and Drug Administration (FDA) approval. Hypothesis We assessed the hypothesis that clinical trials results submitted to the FDA for approval of novel, high-risk cardiovascular devices often provide comparative efficacy data. Methods Comparative efficacy was defined as the presence of an active control. For all high-risk cardiovascular devices approved by the FDA from 2000 through 2011, we extracted information on comparative efficacy data from Summaries of Safety and Effectiveness Data (Summary) which include study data used to justify FDA approval. All identified studies were examined to determine if they relied upon active controls, historical controls, objective performance criteria, or if they had no control. The proportion of studies containing comparative efficacy data was calculated and cross-tabulated by approval year and device class. A multivariate logistic model was used to assess trends over time and the Kruskal-Wallis test was used to examine differences between device sub-types. Results We examined 114 Summaries which contained 340 cardiovascular device studies. Of these studies, 140 (41%) contained an active control. Historical controls 48 (14%) and objective performance 83 (24%) criteria were commonly used. Sixty-nine (20%) of the studies were single-arm studies without controls. In our Summary-level analysis, 74 (65%) devices had an active control in at least one supporting study. Approval year was not significantly associated with type of control arm after controlling for device type in our multivariate logistic analysis. Use of comparative efficacy data was significantly associated with device type. Use ranged from 15/19 (79%) of hemostasis devices to 0/3 (0%) of ventricular assist devices. Conclusions A minority of studies for the highest risk cardiovascular devices approved by the FDA since 2000 included comparative efficacy data through the use of an active comparator arm. Increasing use of active controls would help to better inform regulatory and treatment decisions at the point of FDA approval.

Improving Blood Compatibility of Cardiovascular Devices by Surface Modification

2007 ◽  
pp. 801-804
Author(s):  
Nan Huang ◽  
Ping Yang ◽  
Yong Xiang Leng ◽  
Jun Ying Chen ◽  
Jin Wang ◽  
...  
Keyword(s):  
Surface Modification ◽  
Blood Compatibility ◽  
Cardiovascular Devices
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