InspireMD Submits PMA for Innovative CGuard™ Prime Stent System
InspireMD Takes a Bold Step with PMA Submission for CGuard™ Prime
In an exciting development for stroke prevention technology, InspireMD, Inc. (NASDAQ: NSPR) has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its innovative CGuard™ Prime carotid stent system. This groundbreaking move is poised to bring a new standard of care to the field of carotid artery disease treatment.
The Foundation of PMA Submission
The PMA application is built on the success of the pivotal C-GUARDIANS clinical trial, where overwhelmingly positive results were observed. These findings were initially showcased during the Leipzig Interventional Course (LINC) 2024. In this extensive trial, CGuard was evaluated for its safety and efficacy in treating carotid artery stenosis, focusing on its ability to prevent strokes. With the enrollment of 316 patients across 24 sites in the U.S. and Europe, this trial represents a significant milestone in validating the effectiveness of CGuard.
Outstanding Results from C-GUARDIANS Trial
The results from the C-GUARDIANS trial were impressive, with a primary endpoint of 1.95% major adverse event rate reported at the one-year mark post-procedure. This remarkable rate stands as the lowest event rate documented in any carotid stent or embolic protection device pivotal trial to date, underscoring the potential of the CGuard™ Prime in improving patient outcomes significantly.
Leadership Insights
Marvin Slosman, the Chief Executive Officer of InspireMD, expressed immense pride in this milestone, stating, “The submission represents a significant step forward in our quest for U.S. approval of our next generation CGuard Prime stent. We are committed to addressing carotid artery disease and stroke prevention, particularly with the best-in-class clinical outcomes we are achieving.” He further noted the strategic approach taken, mentioning that the application was provided in a modular format to streamline the review process by the FDA.
Preparing for U.S. Launch
Looking ahead, InspireMD anticipates a U.S. commercial launch in the first half of 2025, pending regulatory approval. This proactive timeline is indicative of the company’s progressive vision for bringing advanced medical technology to market. As preparations ramp up, InspireMD is focused on establishing a robust commercial and operational infrastructure necessary to introduce the CGuard™ Prime system with significant momentum in the U.S. healthcare landscape.
About InspireMD
InspireMD’s commitment to innovation is illustrated through its proprietary MicroNet technology, designed to set a new industry standard for carotid stenting. The overarching goal is to deliver exceptional acute results while ensuring long-term, stroke-free outcomes for patients. Cautioning investors and potential customers alike, InspireMD continues to focus on protecting its intellectual property and maintaining compliance with stringent regulatory standards.
Investor Contact Information
For those interested in learning more, InspireMD’s investor relations team is readily accessible. Craig Shore, Chief Financial Officer, can be reached at 888-776-6804 or via email at craigs@inspiremd.com. Additionally, Chuck Padala of LifeSci Advisors is also available at 646-627-8390 or chuck@lifesciadvisors.com, ensuring that investor concerns and inquiries are promptly addressed.
Frequently Asked Questions
What is the purpose of the PMA application submitted by InspireMD?
The PMA application is aimed at seeking FDA approval for the CGuard™ Prime carotid stent system, focusing on its use in preventing strokes.
What were the key findings from the C-GUARDIANS clinical trial?
The trial reported a major adverse event rate of only 1.95%, indicating promising safety and efficacy results.
When does InspireMD anticipate launching the CGuard™ Prime in the U.S.?
The company aims for a U.S. commercial launch in the first half of 2025, contingent upon regulatory approval.
What innovative technology does InspireMD utilize?
InspireMD incorporates proprietary MicroNet technology to enhance the effectiveness and safety of its carotid stenting products.
Who can investors contact for more information about InspireMD?
Investors can reach out to Craig Shore or Chuck Padala for any inquiries regarding the company's operations and developments.
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