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 submission, aiming to bring this innovative product to the U.S. market.
Clinical Trial Data Supporting NSPR’s Approval
The FDA’s approval of CGuard Prime is based on data from the pivotal C-GUARDIANS clinical trial. This trial enrolled 316 patients across 24 sites in the United States and Europe, evaluating the safety and efficacy of the CGuard stent for treating CAS. The study's primary endpoint was the occurrence of major adverse events, including stroke, death, myocardial infarction and target vessel revascularization. Over a one-year follow-up period, the trial demonstrated a major adverse event rate of 1.95%, the lowest reported for any carotid stent or embolic protection device in a pivotal trial to date.
The trial results showcased the CGuard system’s ability to significantly reduce the risk of stroke, death, myocardial infarction and target vessel revascularization. Its innovative MicroNet technology proved to be a critical factor in preventing embolic debris from entering the brain, offering outstanding neuroprotection in patients with obstructive carotid artery disease.
Device Details and Portfolio Expansion
The CGuard Prime 80cm system is optimized for use in transcarotid revascularization procedures, offering a less invasive alternative to traditional carotid artery surgery. This system’s advanced neuroprotective features ensure that patients with high risk for carotid endarterectomy have a safe and effective treatment option. The CGuard’s design minimizes the risk of complications and the need for future revascularization procedures, making it a valuable addition to InspireMD’s product portfolio.
With the FDA’s premarket approval, InspireMD is well-positioned to expand its presence in the U.S. market. The FDA approval of the CGuard Prime system, coupled with plans for a U.S. commercial launch in 2025, signals a promising future for InspireMD’s global growth.
Other Industry Players
Some other companies from the medical products industry making notable developments in their respective businesses are Medtronic Plc MDT, GE HealthCare Technologies Inc. (GEHC) and Boston Scientific Corporation (BSX).
Medtronic is a leading global healthcare technology company offering innovative technologies and therapies for 70 health conditions, including cardiac devices, surgical robotics, insulin pumps, and patient monitoring systems, transforming lives every second.
In June, Medtronic expanded its Cardiovascular business, driven by strong growth in Cardiac Rhythm Management and Cardiac Pacing following the launch of its Micra AV2 and VR2 devices. The company is also gaining market share in Transcatheter Aortic Valve Replacement, with the recent FDA approval of its Evolut FX Plus valve.
GE HealthCare focuses on personalized and connected care across its Imaging, Ultrasound, Patient Care Solutions and Pharmaceutical Diagnostics sectors.
In August, GE HealthCare received CE marks for two innovative technologies — the Vscan Air SL wireless handheld ultrasound with Caption AI and ECG-less cardiac CT scanning on its Revolution Apex platform. The Vscan Air SL enables rapid cardiac assessments with AI-driven guidance, allowing non-experts to capture high-quality heart images. The ECG-less cardiac CT system simplifies cardiac imaging by eliminating the need for ECG signals, thereby improving speed and accessibility for clinicians.
Boston Scientific offers a diverse portfolio of high-performance devices and therapies that support physicians in diagnosing and treating complex conditions across cardiovascular, respiratory, digestive, oncological, neurological and urological disciplines, while also reducing healthcare costs.
Last Month, Boston Scientific received approval in Japan for its FARAPULSE Pulsed Field Ablation (“PFA”) System, used to treat paroxysmal atrial fibrillation (AF) by isolating pulmonary veins. The non-thermal PFA system, already used in more than 125,000 patients globally, provides a safer alternative to thermal ablation. Presently approved in over 65 countries, it marks a significant shift in AF treatment, benefiting physicians as well as patients.
Zacks' Research Chief Names "Stock Most Likely to Double"
Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.
This top pick is among the most innovative financial firms. With a fast-growing customer base (already 50+ million) and a diverse set of cutting edge solutions, this stock is poised for big gains. Of course, all our elite picks aren’t winners but this one could far surpass earlier Zacks’ Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months.
Free: See Our Top Stock And 4 Runners UpBoston Scientific Corporation (BSX) : Free Stock Analysis Report
Medtronic PLC (MDT) : Free Stock Analysis Report
InspireMD, Inc. (NSPR) : Free Stock Analysis Report
GE HealthCare Technologies Inc. (GEHC) : Free Stock Analysis Report
To read this article on Zacks.com click here.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
