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Purpose: To demonstrate clinical safety and efficacy of the MULTI-LINK MINI VISION RX Coronary Stent System (CSS) when used to treat patients with abrupt or threatened abrupt closure (ATC) of de novo or restenotic lesions in native coronary arteries or arterial bypass graft conduits.
The Guidant MULTI-LINK VISIONTM Coronary Stent has been shown to be MRI safe immediately following implantation at field strengths of 1.5 tesla or less, a maximum spatial gradient of 450...
5 Δεκ 2022 · Overview - Cobalt Chromium FDA engaged ECRI to perform a comprehensive literature search and systematic review to identify the current state of knowledge with regard to medical device material ...
23 Σεπ 2015 · See the Device Component Description sections below for additional information on the XIENCE Family of Stents. XIENCE V and XIENCE nano—Device Component Description. The device component...
MULTI-LINK MINI-VISION RX delivery systems were approved for deployment of the bare metal MULTI-LINK MINI-VISION stent in P020047/S003 (approved September 10, 2004).
VISION ® Coronary Stent or the MULTI-LINK MINI VISION ® Coronary Stent coated with a formulation containing everolimus, the active ingredient, embedded in a non-erodible polymer. The MULTI-LINK VISION ® stents are manufactured from medical grade L-605 cobalt chromium (CoCr) alloy.
Compared to first generation of DES in RCTs, at a mean follow-up of 10.5 months, MLV achieved similar results in terms of MAE, death and MI. On the other hand, MLV was associated with a double risk of TVR [OR 2.01 (1.34-3.01), P < 0.001, number needed to treat 18 (13-40)].