SmartFit™ enhances conformability and apposition regardless of vessel tortuosity or diameter
CAUTION: Federal (USA) law restricts these devices to sale by
or on the order of a physician. See instructions for use for full
prescribing information.
The CGuard Prime Carotid Stent System, when used in conjunction with embolic protection devices
specified in the labeling, is indicated for improving carotid luminal diameter in patients at high
risk
for adverse events from carotid endarterectomy who require carotid revascularization and meet both
criteria outlined below:
- Patients with neurological symptoms and ≥ 50% stenosis of the
common or internal carotid artery by angiogram, or patients without neurological symptoms and ≥
80%
stenosis of the common or internal carotid artery by angiogram.
- Patients having a vessel with reference diameters between 6.4mm and 9.0mm at the target lesion.
The CGuard Prime Carotid Stent System should be used in conjunction with the Abbott Emboshield NAV6™
Embolic Protection System or the Medtronic Mo.Ma™ Ultra Proximal Cerebral Protection Device.
CGuard® and the InspireMD Logo are registered trademarks of
InspireMD, Inc.
Abbott® and Emboshield NAV6™ are registered trademarks of
Abbott Laboratories.
Medtronic® and Mo.Ma™ are registered trademarks of Medtronic
Corporation.
References:
- Musialek P et al. PARADIGM-Extend Prospective Academic Trial: Accumulating long-term evidence
for MicroNet™-covered stent safety and stroke prevention efficacy. Presentation at ESC Congress
2019, Paris, France, 31 August 2019 to 4 September 2019.
- InspireMD, Inc. C-GUARDIANS Pivotal Trial: Primary Endpoint Clinical Study Report. Version F
(Protocol PRO-9017).
- Yadav JS, et al. N Engl J Med. 2004 Oct;351(15):1493-1501. doi: 10.1056/ NEJMoa040127.
- Matsumura JS, et al. J Vasc Surg. 2012 Apr;55(4):968-76. doi: 10.1016/j.jvs.2011.10.120.
- Higashida R, et al. Stroke vol. 41,2 (2010): e102-9. doi: 10.1161/STROKEAHA.109.564161.
- Brott TG, et al. N Engl J Med. 2010 Jul;363(1):11-23. doi: 10.1056/NEJMoa0912321. Epub 2010 May
26.
- Kwolek CJ, et al. J Vasc Surg. 2015 Nov;62(5):1227-34. doi: 10.1016/j.jvs.2015.04.460.
- U.S. Food and Drug Administration. Summary of safety and
effectiveness data (SSED): Roadsaver/CASPER Carotid Stent System (PMA P210030). Published
November 20, 2024
- Gray WA, et al. J Am Coll Cardiol Intv. 2025 Feb;18(3):367-76. doi:
10.1016/j.jcin.2024.10.031.
- Safian RD, et al. J Am Coll Cardiol. 2006 Jun;47(12):2384-89. doi: 10.1016/j.jacc.2005.12.076.
- Langhoff R, et al. Cardiovasc Intervent Radiol. 2025 Mar;Vol 48 427–37.
doi:10.1007/s00270-025-04003-z.
- Wissgott C, et al. J Endovasc Ther 2017;24(1):130-137
- Musialek P, Hopkins LN, Sidiiqui AH. Postepy Kardiol Interwencyjnej