FDA Recommendations for Nitinol Stent and Endovascular Graft Fatigue Characterization and Fracture Reporting

2006 ◽  
Vol 3 (6) ◽  
pp. 100384 ◽  
Author(s):  
KJ Cavanaugh ◽  
VM Holt ◽  
JL Goode ◽  
E Anderson ◽  
SW Dean
Keyword(s):  
Nitinol Stent ◽  
Endovascular Graft

FDA Recommendations for Nitinol Stent and Endovascular Graft Fatigue Characterization and Fracture Reporting

2009 ◽  
pp. 110-110-7 ◽  
Author(s):  
Kenneth J. Cavanaugh ◽  
Vivianne M. Holt ◽  
Jennifer L. Goode ◽  
Evan Anderson
Keyword(s):  
Nitinol Stent ◽  
Endovascular Graft

Crush implantation of a self-expanding interwoven stent over a subintimally recanalized standard stent in a TASC D lesion of the superficial femoral artery

VASA ◽  
2012 ◽  
Vol 41 (6) ◽  
pp. 458-462 ◽  
Author(s):  
Vogel ◽  
Strothmeyer ◽  
Cebola ◽  
A. Katus ◽  
Blessing
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Popliteal Artery ◽  
Duplex Ultrasound ◽  
Stent Fracture ◽  
Nitinol Stent ◽  
Nitinol Stents ◽  
Walking Capacity ◽  
Radial Strength ◽  
Good Treatment Option

We demonstrate feasibility of implantation of a self-expanding interwoven nitinol stent in a claudicant, where recanalization attempt of a heavily calcified, occluded superficial femoral artery (TASC D lesion) was complicated by a previously implanted, fractured standard stent. Wire passage through the occlusion and beyond the fractured stent could only be achieved through the subintimal space. A dedicated reentry device was used to allow distal wire entry into the true lumen at the level of the popliteal artery. Despite crushing of the fractured stent with a series of increasingly sized standard balloons, a significant recoil remainded in the area of the crushed stent. To secure patency of the femoro-popliteal artery we therefore decided to implant the novel self-expanding interwoven nitinol stent (Supera Veritas (TM), IDEV), whose unique feature is an exceptional high radial strength. Patient presented asymptomatic without any impairment of his walking capacity at three month follow up and duplex ultrasound confirmed patency of the stent. Subintimal recanalizations can be complicated by previously implanted stents, in particular in the presence of stent fracture, where intraluminal wire passage often can not be achieved. Considering the high radial strength and fracture resistance, interwoven nitinol stents represent a good treatment option in those challenging cases and they can be used to crush standard nitinol and ballonexpandable stents.

Three year results of endovascular therapy with a new generation nitinol stent for femoro-popliteal artery lesions - a single-center outcome analysis of a subcohort of MISAGO 2 study

VASA ◽  
2013 ◽  
Vol 42 (5) ◽  
pp. 340-349 ◽  
Author(s):  
Ivan Kralj ◽  
Irene Boos ◽  
Uwe Müller-Bühl
Keyword(s):  
Popliteal Artery ◽  
Clinical Success ◽  
Ankle Brachial Index ◽  
Long Term Results ◽  
Outcome Analysis ◽  
Stent Fracture ◽  
Nitinol Stent ◽  
New Generation ◽  
Stent Stenosis

Background: Advances in stent technology have widened the field of indications for stent treatment of femoro-popliteal artery lesions, however the use of stents in bending arterial segments is restricted because some first- and second-generation nitinol stent designs did not respond well to the mechanical forces of femoro-popliteal segments in motion which pose a substantial risk of stent fracture inducing in-stent-stenosis. New generation nitinol stents are supposed to overcome these limitations but long-term results are rare. Patients and methods: In forty-five patients (mean age 68 y, range 50 - 85) with peripheral arterial disease (TASC II A-C, Rutherford category 2 - 5) forty-six lesions of the superficial femoral artery (37) or popliteal artery (9) were treated [25 high-grade stenoses, mean length 53 mm (range 30 - 145 mm); 21 chronic total occlusions, mean length 74 mm (range 30 - 180 mm)]. 74 % of lesions were located in the mobile bending arterial segments in the distal femoral or the popliteal segment. Clinical reevaluation performed at discharge, at 6, 12, 24, and 36 months included at least the measurement of ankle-brachial index (ABI) and duplex sonography. Results: Procedural success rate was 100 %. At 6, 12, 24, and 36 months, cumulative primary patency rate was 93.5 %, 84.8 %, 80.5 %, and 74.3 % (SE<10); freedom from target lesion revascularization rate was 95.7 %, 89.2 %, 84.9 %, and 79.3 % (SE<10); Rutherford category and ABI improved in all patients and clinical success was maintained in more than 85 % of patients. Conclusions: Sustained technical and clinical success and good clinical long-term results were achieved with Misago™ nitinol stent implantation in femoro-popliteal lesions with moderate risk for in-stent-stenosis, and in the distal femoral and popliteal mobile segment.

Erfahrungen mit einem neuen selbstexpandierenden Y-Nitinol-Stent. Fallbeispiele mit schwierig zu stentenden Befunden

Pneumologie ◽  
2007 ◽  
Vol 61 (S 1) ◽  
Author(s):  
I Dobbertin ◽  
K Schmid ◽  
H Wurst ◽  
R Jaki ◽  
W Spengler ◽  
...  
Keyword(s):  
Nitinol Stent

Physical Properties of a New Type of Self-expandable Nitinol Stent

1999 ◽  
Vol 41 (2) ◽  
pp. 275
Author(s):  
SangSoo Park ◽  
Tae Hyung Kim ◽  
Sang Woo Song ◽  
Seong Gwon Kang ◽  
Soo Jin Huh ◽  
...  
Keyword(s):  
Physical Properties ◽  
Nitinol Stent ◽  
New Type

Endovascular Graft Infection: Preliminary Results of an International Enquiry

2003 ◽  
Vol 10 (5) ◽  
pp. 919-927 ◽  
Author(s):  
Paolo Fiorani ◽  
Francesco Speziale ◽  
Annalisa Calisti ◽  
Maria Misuraca ◽  
Davide Zaccagnini ◽  
...  
Keyword(s):  
Graft Infection ◽  
Preliminary Results ◽  
Endovascular Graft

Clinical Experience with a New Nitinol Self-Expanding Stent in Peripheral Arteries

1996 ◽  
Vol 3 (4) ◽  
pp. 369-379 ◽  
Author(s):  
Michel Henry ◽  
Max Amor ◽  
Rafael Beyar ◽  
Isabelle Henry ◽  
Jean-Marc Porte ◽  
...  
Keyword(s):  
Long Term Results ◽  
Lesion Length ◽  
Secondary Patency ◽  
Peripheral Arteries ◽  
External Compression ◽  
Nitinol Stent ◽  
Nitinol Stents ◽  
The Mean

Purpose: To evaluate a new self-expanding nitinol coil stent in stenotic or occluded peripheral arteries. Methods: Seventy-three symptomatic patients (58 men; mean age 67 years) were treated with nitinol stents for lesions in the iliac artery (9 stenoses); superficial femoral artery (SFA) (39 stenoses, 6 occlusions); popliteal artery and tibioperoneal trunk (9 stenoses, 7 occlusions); and 3 bypass grafts. Mean diameter stenosis was 84.4% ± 9.9% (range 75% to 100%), and mean lesion length was 45 ± 23 mm (range 20 to 120 mm). Results: Eighty-eight 40-mm-long stents with diameters between 5 and 8 mm were implanted percutaneously for suboptimal dilation (n = 45); dissection (n = 21); and restenosis (n = 7). All stents but one were implanted successfully; the malpositioned stent was removed, and another stent was successfully deployed. There were 3 (4.1%) failures due to thrombosis at 24 hours. During the mean 16-month follow-up (range to 44 months), 4 restenoses (3 femoral, 1 popliteal) have occurred; 2 were treated with repeat dilation and 2 underwent bypass. Primary and secondary patency rates at 18 months were 87% and 90%, respectively, for all lesions (iliac: 100% for both; femoral: 85% and 88%; popliteal: 87% and 100%). Conclusions: This new nitinol stent seems to be safe and effective with favorable long-term results, even in distal SFA lesions and popliteal arteries. Its flexibility and resistance to external compression allow its placement in tortuous arteries and near joints.

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