The sst is designed to conform to fixed anatomy and is easier to position and trim. This guide also provides information on how to maintain continued supply of the atrium products. Setup of these devices is a breeze with atrium s free software. Advanta v12 ballonexpandierbarer gecoverter stents getinge group. Medical device straight reinforced advanta sst 25032. Both devices were explanted since they were both in the infected field. Atrium advanta v12 has canadian health ministry approval for restoring the patency of iliac lesions. Modified prosthetic vascular conduits circulation aha journals.
Event type injury event description the graft didnt taper and when it was laid flat it measured 10mm at the gds connection up until the immediate connection where it measured 6mm a sudden taper of less than 5mm in length. Atrium medical corporation and three other affiliated maquet companies reached an agreement concerning a consent decree decree with the u. We are a liquidator of sutures and other surgical items from ethicon, covidien autosuture, synthes, stryker, arthrex and are able to pass our savings on to you. In addition, it provides instructions how to handle product that may be affected. The md agreed that it should be fine that the sst would fill without issue. Medical device advanta vxt straight straight 21185. They attempted to straighten out and was unable to completely. Advanta sst graft was used in 17 patients group a, agsv in 30 group b and composite advanta agsv graft in the remaining 14 group c.
We strive to improve daily patient management through futureoriented technology and continuous investment in advanced clinical solutions that reduce costs and improve patient outcomes. Its tab style interface allows you to open and work with multiple windows at same time. The advanta sst graft is thinner and more pliable than the goretex 0. Atrium advanta sst graft sewn together with a radiographic marker. While you are entering an invoice or bill, you can pause and jump to enter a receipt or view ledger or other reports without closing any opened window. The embedded web server provides instant results using any web browser, smartphone or tablet. Atrium medical corp,vascular patch knitted ivena atrium. The advanta family of ptfe vascular grafts in particular offers many choices for specific needs or applications. The large diameter, balloon expandable, ptfe covered stent. Advanta sst aortic repair graft atrium medical corporation. The ultra low crossing profile is made possible by atrium s power crimp technology and atrium s anertia balloon catheter technology.
Atrium, 22026, atrium advanta vxt standard wall vascular. Atrium medical corporation issued an urgent medical device safety alert letter on july 16, 20, via ups to customers and email to the field representatives that represent these accounts. Advanta sst atriums sst aortic repair grafts are constructed from an amazing hydrostatic protection membrane system utilizing stateoftheart film lamination technology. Accessgudid advanta slider gds 00650862250169 advanta graft, 7mmx50cm, advanta sst, gds. Atrium, 22266, atrium advanta vxt thin wall vascular graft. Advanta sst utilizes atriums proprietary trilaminate construction, which includes a hydrostatic protection membrane, known as hp3 sst vascular graft with slider gds technology, which offers reduced weeping and needle hole bleeding. Atrium, 21062, atrium advanta vxt ptfe standard wall vascular. Atriums ivena patch is the thinnest ptfe vascular patch available on the market. Integrated library solutions book systems offers the ultimate library automation solution for all types of libraries from individual and multibranch public libraries to individual schools and entire districts to special libraries. With an extensive selection of comprehensive educational programs, atrium university is a free resource offered to clinicians to further their knowledge of how to manage chest drainage. Atrium advanta vxt softwrap technology makes grafts softer and easier to handle peripheral bypasshemodialysis access advanta sst trilaminate construction allows graft to pulse after implantation peripheral bypass advanta vs single layer, improved incorporation after implantation peripheral bypasshemodialysis access flixene 3 layers. Atrium s large diameter v12 is available for restoring the patency of iliac arteries.
Use of an expanded polytetrafluoroethylene patch as an artificial. The advanta sst graft atrium is composed of three layers of ptfe ie, two outer microporous layers, similar to the goretex patch, and one dense middle layer. Get assigned drive information including capacity, used space on drive,drive temperature, drive health, and lifespan of drive. From atrium the atrium s v12 is a onestep delivery system, and is suitable for vessels ranging from 5mm to 12mm diameters. In the time following the release of the consent decree, manufacturing of all biosurgery products has been restarted at maquets new facility in merrimack, new hampshire. User reported graft appeared to be creased and twisted when removed from packaging.
Atriums large diameter v12 is available for restoring the patency of iliac arteries. Treatment of acute visceral aortic pathology with fenestrated. Whether you prefer the remarkably veinlike performance of the advanta sst graft, the strength of the advanta vxt, or the strength and handling combination of the advanta vs, youll find the same atrium quality and highperformance ptfe construction in each, as well as remarkable features. Sst large diameter straight aortic repair graft the advanta sst ptfe straight grafts, utilizing the same trilaminate ptfe construction as the bifurcated grafts, are specifically designed to provide a highstrength, kinkresistant solution for aortic repair. Advanta ultramax product catalog without pricing atrium medical. This voluntary agreement was approved by a federal judge in new hampshire on february 3rd, 2015 and establishes a framework that provides assurances to the fda that. Atrium offers a family of unique, innovative and advanced vascular grafts.
The atrium s v12 is a onestep delivery system, and is suitable for vessels ranging from 5mm to 12mm diameters. The notification identifies the problem, product, and risk factors. Accessgudid advanta slider gds 006508622508 advanta graft, 47mmx45cm, 5 ring, sh, adv sst, gds skip to main content u. The event has been communicated to the manufacturer for hemagard. The decree addresses concerns raised by fda during inspections of atrium and other maquet manufacturing facilities conducted in 20. Atrium advanta sst ptfe vascular graft, ringed 6mm x 50cm x 15cm double slider gds. Atrium, 22297, atrium advanta vxt ptfe vascular graft slider gds. Under the terms of the decree, manufacturing of these products was discontinued at atriums hudson, new hampshire facility. Upon completion of procedure md dopplered exposed graft, both proximal and distal, and there seemed to be adequate flow. The ivena patch is an ultrathin ptfe vascular patch with a wall thickness that is approximately 0. Atrium, advanta vxt, softwrap technology makes grafts softer and easier to handle, peripheral bypasshemodialysis access. Atrium, 21062, atrium advanta vxt ptfe standard wall.
Two different endografts medtronicendurant abdominal stent graft and goreexcluder abdominal aortic aneurysm endoprosthesis. It was a misunderstanding of which end the slider gds was on and the diameter differences when the advanta sst is laid flat versus in a circular graft like shape. Atrium offers a family of unique, innovative and advanced vascular grafts tailored to meet the specific needs of various applications and to suit the preferences and techniques of individual vascular surgeons. Advanta sst advanta sst large diameter vascular graft accessories tunneler vein graft tunneling system. Medical device straight reinforced advanta vxt 22063. The ivena ptfe patch is essentially the advanta sst ptfe graft that has been laser cut to specific shapes for use as a patch material. Invitro silicon aneurysmal neck models of different diameters, with one sidebranch, were constructed. Advanta sst graft, the strength of the advanta vxt, or the strength and handling combination of the advanta vs, youll find the same atrium quality and. List of devices made by the manufacturer atrium medical. Use of an expanded polytetrafluoroethylene patch as an. Atrium allows you to manage up to 500 doors, proximity card readers, keypads or schlage wireless door handles. We report our experience with the use of ptfe trilaminate graft advanta sst atrium maquet versus autologous great saphenous vein agsv and composite ptfe trilaminatevein graft for belowtheknee btk revascularization.
Accessgudid advanta slider gds 00650862250190 advanta graft, 7mmx80cm, 20 ringed, adv sst, dbl, gds. Atrium s commitment to clinical education is second to none. Vascular graft atrium esutures the suture superstore. The medical device straight reinforced advanta sst is realized by atrium medical corporation. When advanta sst was employed, the median duration of intervention was significantly lower than using vein or composite grafts 212 minutes, iqr.
Quick diagnostics, which will run basic tests on free space of the selected drive, and full diagnostics, whick runs a read test on all used space of the selected drive. The best conditions for parallel stenting during evar. The large diameter, balloon expandable, ptfe covered stent can be used to treat vessels larger than 12mm. The medical device advanta vxt straight straight is realized by atrium medical corporation.
Accessgudid advanta slider gds 006508622508 advanta graft, 47mmx45cm, 5 ring, sh, adv sst, gds. The advanta family of ptfe vascular grafts in particular offers many choices for specific needs. Prosthesis, vascular graft, of 6mm and greater diameter. The staff member stated the concern was for the hemagard device and not the advanta sst graft. Advanta witty turbo is a multitasking accounting software. The instructions for use for advanta ptfe grafts specifically state. Medical device straight reinforced advanta vxt 21078. All statistical analyses were performed using stata software v. In this list are all medical devices registered by the ministry of health that are produced by the manufacturer atrium medical corporation.
Longterm results of ptfe trilaminate graft versus venous. Caritas maquet getinge group vascularaortic surgery. The medical device straight reinforced advanta vxt is realized by atrium medical corporation. The ultrathin trilaminate design allows for unparalleled strength. Atrium, along with three other affiliated maquet companies, entered into a decree with the u.1026 632 373 906 376 227 1369 829 691 1047 537 432 1407 1127 472 1324 754 561 658 1257 934 712 616 402 240 1203 993 168 1278 1489 693 474 110 482 924 1148 522 875 684 1299 280 828