InspireMD Gains FDA Premarket Approval for CGuard Prime Carotid Stent [Yahoo! Finance]
InspireMD Inc. (NSPR)
NASDAQ:AMEX Investor Relations:
inspiremd.com/en/investors/investor-relations
Company Research
Source: Yahoo! Finance
InspireMD 's NSPR recently announced that the FDA has granted investigational device exemption (IDE) or premarket approval for its CGuard Prime 80cm carotid stent system. This approval allows the company to market its carotid stent system in the U.S. market for treating carotid artery stenosis (CAS), a condition that increases the risk of stroke. The approval is based on the impressive clinical trial results of the CGuard stent system, which demonstrated strong efficacy and safety in preventing stroke during carotid revascularization procedures. Before receiving premarket approval from the FDA, InspireMD's CGuard system had already obtained a CE mark in 2024. The system uses InspireMD's proprietary MicroNet technology, which is designed to trap embolic debris while maintaining uninterrupted blood flow. This technology provides a long-term, stroke-free solution for patients with carotid artery disease. The device's clinical success in Europe laid the foundation for InspireMD's FDA
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NSPR
News
- InspireMD, Inc. (NYSE: NSPR) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- InspireMD Announces Expected Retirement of its CFO Craig Shore and CFO Transition in 2025 [Yahoo! Finance]Yahoo! Finance
- InspireMD Announces Expected Retirement of its CFO Craig Shore and CFO Transition in 2025GlobeNewswire
- InspireMD, Inc. (NYSE: NSPR) is now covered by analysts at Lake Street Capital. They set a "buy" rating and a $5.00 price target on the stock.MarketBeat
- InspireMD Announces First Patient Enrolled in the CGUARDIANS II Pivotal Study of the CGuard Prime Carotid Stent System in Transcarotid Artery Revascularization Procedures (TCAR) [Yahoo! Finance]Yahoo! Finance
NSPR
Earnings
- 11/12/24 - Beat
NSPR
Sec Filings
- 12/12/24 - Form 8-K
- 12/9/24 - Form 8-K
- 12/4/24 - Form SC
- NSPR's page on the SEC website