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The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices.

ABSTRACT: The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage. To supplement bench data in regulatory submissions, manufactures can evaluate the effects of anatomical characteristics and expected in vivo loading environment on device performance. Manufacturers might also harness CM&S to aid root-cause analyses that are necessary when failures occur postmarket, when the device is exposed to broad clinical use. Once identified, CM&S tools can then be used for redesign to address the failure mode and re-establish the performance profile with the appropriate models. The Center for Devices and Radiological Health (CDRH) wants to advance the use of CM&S for medical devices and supports the development of virtual physiological patients, clinical trial simulations, and personalized medicine. Thus, the purpose of this paper is to describe specific examples of how CM&S is currently used to support regulatory submissions at different phases of the TPLC and to present some of the stakeholder-led initiatives for advancing CM&S for regulatory decision-making.

SUBMITTER: Morrison TM

PROVIDER: S-EPMC5823268 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices.

Morrison Tina M TM Dreher Maureen L ML Nagaraja Srinidhi S Angelone Leonardo M LM Kainz Wolfgang W

Journal of medical devices 20170123 2

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postma ...[more]

PMID: 29479395

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Project description:BackgroundDespite limited evidence, peripheral vascular disease is often cited as a contraindication for total ankle arthroplasty. The purpose of our study was to identify whether peripheral vascular disease in patients undergoing total ankle arthroplasty increased the rate of infection, postoperative irrigation and debridement, or failure of the implant.MethodsThe PearlDiver Database was used to identify Medicare patients who underwent a total ankle arthroplasty from 2005 to 2014. These data were then analyzed for postoperative infections within 90 days, subsequent irrigation and debridements, and failure of total ankle arthroplasties. A diagnosis of preoperative peripheral vascular disease only included those patients who had peripheral vascular disease as an ICD-9 diagnosis code and underwent a preoperative lower extremity angiogram prior to total ankle arthroplasty. Medical comorbidities were identified using ICD-9 diagnosis codes. Three multivariable logistic regression models were then developed in order to identify risk factors associated with postoperative infections and failure after total ankle arthroplasty.ResultsA total of 10 698 Medicare patients who underwent a primary total ankle arthroplasty were identified. There were 334 patients who had a postoperative infection within 90 days of their total ankle arthroplasty, and 95 of those patients required an irrigation and debridement. Regression analysis demonstrated that patients with peripheral vascular disease had the greatest risk of developing a postoperative infection within 90 days (OR 2.85, P < .01), requiring an irrigation and debridement postoperatively (OR 4.87, P < .001), and having a total ankle arthroplasty failure at any time point postoperatively (OR 2.51, P < .001).ConclusionsOur study suggests that preoperative peripheral vascular disease is a significant risk factor for an acute postoperative infection, postoperative irrigation and debridement, and failure of the implant in Medicare patients undergoing a total ankle arthroplasty.Level of evidenceLevel III, therapeutic.

Dataset Information

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices.

Publications

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices.

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