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 Third Quarter 2024 Earnings: US$0.16 loss per share (vs US$0.15 loss in 3Q 2023) [Yahoo! Finance]Yahoo! Finance
- InspireMD Inc (NSPR) Q3 2024 Earnings Call Highlights: Revenue Growth Amid Rising Costs and ... [Yahoo! Finance]Yahoo! Finance
- InspireMD Reports Third Quarter 2024 Financial Results and Provides Business UpdateGlobeNewswire
- What To Expect From InspireMD Inc (NSPR) Q3 2024 Earnings [Yahoo! Finance]Yahoo! Finance
NSPR
Earnings
- 11/12/24 - Beat
NSPR
Sec Filings
- 11/14/24 - Form SC
- 11/14/24 - Form SCHEDULE
- 11/12/24 - Form 10-Q
- NSPR's page on the SEC website