Salient_Characteristic_Form_Icast_Stents_Hemashield_Grafts_549-19-1-083-0012.docx

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NTX Dallas Icast Stents & Grafts
Solicitation number
36C25719Q0196
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36C25719Q0196 Salient Characteristic Form Icast Stents Hemashield Grafts 549-19-1-083-0012.docx

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Sources_Sought_Notice_Description_-_ICAST_Stents_and_Grafts.docx DOCX document

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Purchase Descriptions.

The purchase description should identify the requirement in terms that enable contractors to offer commercial supplies or services. The description should not be restrictive and not be limited to one product peculiar to a manufacturer (e.g., by manufacturer, brand name and Part Number) unless it is essential to the Government’s minimum requirement.

A purchase description should include the following characteristics based on the requirement to adequately describe the Government’s needs:

(Please fill in the blocks provided with the information that is requested. If not applicable, then so state)

a.
Common Nomenclature (commercial description):
atrium iCAST™ Balloon expandable Covered Stent
b.
Kind of material (i.e., type, grade, alternatives, etc.):
Atrium’s iCAST™ balloon expandable covered stent is FDA 510(k) cleared for the treatment of tracheobronchial strictures.
c.
Electrical Data (i.e., 110 v, 60 Hz, 3 Ph, etc.):
N/A
d.
Dimensions, size, capacity:
N/A
e.
Principles of operation:
The iCAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. The iCAST stent is crafted using Atrium’s PTFE encapsulation technology and a one-step deployment technique for precise, accurate deployment.
f.
Restrictive environmental conditions:
N/A
g.
Intended use:
Atrium’s iCAST™ balloon expandable covered stent is FDA 510(k) cleared for the treatment of tracheobronchial strictures.
h.
Equipment with which the item is used with

(N/A if not applicable):

N/A

i.
End item application:
N/A
j.
Original equipment manufacturer part number:
85453;85413;85455;85417;85419;85443;85445
k.
Other pertinent information that describes the item, material or service required:
· The ultra-thin iCAST covered stent utilizes the latest developments in PTFE film lamination technology. Atrium’s Film-Cast Encapsulation Technology protects the 316L stainless steel struts from contacting the luminal wall and is designed to expand uniformly to prevent tissue from prolapsing through the expanded stent. The patented filmcast covering also helps evenly distribute radial expansion stress during balloon deployment, creating a more uniform deployment. The iCAST™ covered stent has a low crossing profile. Low profile means efficient delivery.
a.
Common Nomenclature (commercial description):
Hemashield Platinum Woven Double Velour GraftsHEMASHIELD PLATINUM Woven Double Velour Grafts
b.
Kind of material (i.e., type, grade, alternatives, etc.):
Collagen-impregnated.collagen-impregnated and come in straight, one-branch, or multi-branch graft configurations for aortic repair.
c.
Electrical Data (i.e., 110 v, 60 Hz, 3 Ph, etc.):
N/A
d.
Dimensions, size, capacity:
N/A
e.
Principles of operation:
Aortic repaircollagen-impregnated and come in straight, one-branch, or multi-branch graft configurations for aortic repair.
f.
Restrictive environmental conditions:
N/A
g.
Intended use:
Aortic repair
h.
Equipment with which the item is used with

(N/A if not applicable):

N/A

i.
End item application:
N/A
j.
Original equipment manufacturer part number:
M00202166126P0; M00202166147P0; M00202166168P0; M00202166189P0;

M00202166201P0; M00202166221P0

k.
Other pertinent information that describes the item, material or service required:
Four-Branch Graft: Observed clinical advantages of the four-branch arch graft replacement include

· Dramatically reduced cerebral circulatory arrest times1,2,3

· Significantly lowered risk of mortality and risk of neurologic dysfunction2

· Negated the need for direct cannulation of brachiocephalic arteries, which reduces the risk of embolization of air or atherosclerotic debris1,2

· Provides an alternative technique to the Island Technique with retrograde perfusion via femorals Angled Four-Branch Graft

· This four-branch graft Includes one branch for perfusion and three angled branches (60 degrees) for repair or replacement of the head vessels

· Angled design mimics the natural anatomy of the head vessels One-Branch Graft: The straight and one-branch grafts may be used for various procedures, including

· Ascending thoracic aortic repair

· Descending thoracic aortic repair

· Ascending and innominate repair (with one-branch graft)

· Island Technique for arch repair Thoraco-Abdominal Aortic Aneurysm (TAAA) Graft

· Designed for repair or replacement of the thoracic and abdominal portions of the aorta

· Applications include replacement of the right and left renal arteries as well as the superior mesenteric artery and celiac arteries Four-Branch Graft: Observed clinical advantages of the four-branch arch graft replacement include

· Dramatically reduced cerebral circulatory arrest times1,2,3

· Significantly lowered risk of mortality and risk of neurologic dysfunction2

· Negated the need for direct cannulation of brachiocephalic arteries, which reduces the risk of embolization of air or atherosclerotic debris1,2

· Provides an alternative technique to the Island Technique with retrograde perfusion via femorals Angled Four-Branch Graft

· This four-branch graft Includes one branch for perfusion and three angled branches (60 degrees) for repair or replacement of the head vessels

· Angled design mimics the natural anatomy of the head vessels One-Branch Graft: The straight and one-branch grafts may be used for various procedures, including

· Ascending thoracic aortic repair

· Descending thoracic aortic repair

· Ascending and innominate repair (with one-branch graft)

· Island Technique for arch repair Thoraco-Abdominal Aortic Aneurysm (TAAA) Graft

· Designed for repair or replacement of the thoracic and abdominal portions of the aorta

· Applications include replacement of the right and left renal arteries as well as the superior mesenteric artery and celiac arteries

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