| Developers: | Bard |
| Branches: | Pharmaceutics, medicine, health care |
2018: Problems with stents for a podvzdoshny artery
In October, 2018 Becton Dickinson notified buyers on the problem connected with the LifeStream stent for a podvzdoshny artery developed by Bard subsidiary company. According to results of researches, the share of a restenoz (excess growth of an inside layer of an artery in stentirovanny section with further difficulty of a blood-groove) among patients of LifeStream appeared above, than it was expected.
In the notification it is specified that the observed share of a repeated stenosis (0.04%) exceeds admissible regulation (0.01%). The quantity of cases of a restenoz which it was announced after implantation of the LifeStream stent in the general clinical practice and within clinical trial of Bolster is not given in the notification, however the company noted that patients do not show complaints to additional complications therefore the product was not withdrawn from the market.
In the USA Bard got permission to sale of the podvzdoshny LifeStream stent for correction of stenozirovanny arteries in June, 2017, and in Europe – in 2014. This stent can be used for treatment of atherosclerotic damages of the general and external podvzdoshny arteries with a diameter from 4.5 mm to 12.0 mm and defeat up to 100 mm long.
In general according to atherosclerotic damages of the general and outside podvzdoshny arteries 155 patients from 17 regions of the USA, Europe and New Zealand participated in the research Bolster. Within the subsequent observation patients looked round specialists in nine months after stenting for assessment of primary and secondary endpoints. Restenoz (narrowing of a gleam of a vessel more than for 50%) within nine months after installation of the stent entered the combined endpoint of a research and was estimated using a duplex ultrasonografiya.
In total all patients will be observed 36 more months, the final decision will be made after this term, however the company warns patients and their attending physicians in advance.[1]
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