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Reflow Medical Secures FDA De Novo Authorization for Spur® Peripheral Retrievable Stent System
Reflow Medical, Inc. is pleased to announce a significant milestone in peripheral artery disease (PAD) treatment with the U.S. Food and Drug Administration’s (FDA) granting of De Novo authorization for its innovative Spur® Peripheral Retrievable Stent System. This authorization, published by Business Wire French Language News on July 15, 2025, marks a pivotal step forward in offering new therapeutic options to patients suffering from PAD.
The Spur® system is designed to address a critical unmet need in the management of peripheral arterial lesions, particularly those that are challenging to treat with existing technologies. The De Novo pathway is specifically designated for novel medical devices that do not have a predicate device already cleared by the FDA, underscoring the unique and innovative nature of Reflow Medical’s technology.
This groundbreaking authorization reflects extensive clinical evaluation and rigorous scientific validation. The Spur® Peripheral Retrievable Stent System aims to provide physicians with enhanced capabilities for lesion crossing, precise stent placement, and importantly, the ability to retrieve the stent if necessary during the procedure. This retrievability feature is a key differentiator, potentially offering an added layer of safety and control for interventionalists and their patients.
“We are thrilled to receive De Novo authorization from the FDA for our Spur® Peripheral Retrievable Stent System,” said a spokesperson for Reflow Medical. “This achievement is a testament to our team’s dedication to developing advanced solutions that can meaningfully improve patient outcomes in the treatment of peripheral artery disease. We believe the Spur® system has the potential to redefine how complex lesions are managed and to offer a valuable new tool to physicians.”
Peripheral artery disease is a widespread condition that affects millions globally, often leading to pain, reduced mobility, and in severe cases, limb loss. Effective treatment options are crucial for restoring blood flow and improving the quality of life for affected individuals. The introduction of the Spur® system is expected to contribute significantly to this effort.
Reflow Medical is committed to advancing cardiovascular and endovascular therapies. The FDA’s De Novo authorization represents a significant validation of their innovative approach and paves the way for wider availability of the Spur® Peripheral Retrievable Stent System to healthcare providers and patients across the United States. The company looks forward to making this advanced technology accessible and contributing to better patient care in the field of peripheral interventions.
La FDA accorde l'autorisation De Novo au Spur® Peripheral Retrievable Stent System de Reflow Medical
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Business Wire French Language News published ‘La FDA accorde l'autorisation De Novo au Spur® Peripheral Retrievable Stent System de Reflow Medical’ at 2025-07-15 06:00. Please write a detailed article about this news in a polite tone with relevant information. Please reply in English with the article only.