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Supera Peripheral Stent System | 合法醫療器材資訊網

Supera Peripheral Stent System

IMPORTANTSAFETYINFORMATION...superficialfemoralartery(SFA)and/orproximalpoplitealarterywithreferencevessel...Thelong-termsafetyandeffectivenessoftheSupera™PeripheralStent...MagneticResonanceImaging(​MRI).

 Supera Peripheral Stent System

Indications: The Supera™ Peripheral Stent System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and / or proximal popliteal artery with reference vessel diameters of 4.0 to 7.5 mm, and lesion lengths up to 140 mm.

Contraindications:

The Supera™ Peripheral Stent System is contraindicated in:

Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system. Patients who cannot receive antiplatelet or anticoagulation therapy. Based on in vivo thrombogenicity testing, the device should not be used in patients who cannot be anticoagulated as there may be some thrombus formation in the absence of anticoagulation.

...

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Complete® SE | 合法醫療器材資訊網
Vascular Stent System - Superficial Femoral Artery (SFA)/Proximal Popliteal Artery (PPA) ... postoperative imaging and implantation procedures. ... The long-​term safety and effectiveness of the Complete SE Vascular Stent System has not been ... Read More
EverFlex Self | 合法醫療器材資訊網
2012年2月7日 — For stent deployment, turn the safety lock counterclockwise to unlock the outer ... of Lesions in the Superficial Femoral Artery and Proximal Popliteal By ... MRI performed for 15-minutes of scanning (i.e., per pulse sequence) in ... Read More
Instructions for Use Cordis SMART0 CONTROLS Vascular ... | 合法醫療器材資訊網
information, all of which present a potential risk to patient safety. ... during MRI of the electromagnetic fields in the body with the stent resulted in a ... the treatment of atherosclerotic lesions of the native superficial femoral artery (SFA) or the  Read More
Bard® LifeStent® Vascular Stent System | 合法醫療器材資訊網
up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal ... The safety and effectiveness of stent overlapping in the middle (P2) and distal ... The LIFESTENT® Vascular Stent has not been evaluated in MRI systems ... Read More
BARD® LIFESTENT® | 合法醫療器材資訊網
Superficial Femoral Artery Balloon Angioplasty and Stenting . ... Safety During Magnetic Resonance Imaging (MRI*) . Read More
THE List | 合法醫療器材資訊網
Read More
Innova™ Vascular | 合法醫療器材資訊網
MAGNETIC RESONANCE IMAGING (MRI) SAFETY. INFORMATION. ... Innova Self-Expanding Stent System in SFA/PPA by comparing to Performance Goals of​ ... Read More
Comparison of 15 different stents in superficial femoral ... | 合法醫療器材資訊網
由 GJ Adams 著作 · 2005 · 被引用 29 次 — Purpose: To evaluate the MRI compatibility of 15 different ... Table 1. Specifications of Stents Inserted into Cadaveric Superficial Femoral Artery Segments. Name. Read More
Supera Peripheral Stent System | 合法醫療器材資訊網
IMPORTANT SAFETY INFORMATION ... superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel ... The long-term safety and effectiveness of the Supera™ Peripheral Stent ... Magnetic Resonance Imaging (​MRI). Read More
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