Manufacturer: Medtronic
Category: Arterio-venous system devices
EMDN: C010402020601 - Peripheral atherectomy systems, directional
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The SilverHawk™ Peripheral Plaque Excision System from Medtronic is a directional atherectomy device designed to treat peripheral arterial disease (PAD). Its core function is to remove plaque buildup from blocked arteries in the legs, restoring blood flow. Here's a breakdown of its key features and USPs: Key Features and USPs: Directional Atherectomy: - The SilverHawk system utilizes a directional cutting blade, allowing physicians to selectively remove plaque from targeted areas. This precision is a significant advantage. - This directional capability allows for the preservation of healthy vessel tissue. Plaque Excision, Not Compression: - Unlike some other methods that compress plaque against the vessel wall, the SilverHawk system physically removes the plaque. - This removal of the obstruction, rather than just displacing it, aims to provide more durable results. Nosecone Capture: - A key feature is the integrated nosecone that captures the excised plaque. This helps to minimize the risk of distal embolization (debris traveling downstream). - This collection of the excised plaque, helps with the removal of the plaque from the body. Preservation of Native Vessel: - By removing plaque rather than compressing it, the SilverHawk system aims to preserve the native vessel structure. - This preservation is crucial for maintaining future treatment options. Clinical Evidence: - The SilverHawk technology is supported by clinical studies, notably the DEFINITIVE LE study, which demonstrated positive outcomes in PAD patients, including high rates of limb salvage. Versatility: - The system is designed to be used in arteries above and below the knee. In essence, the SilverHawk system's strength lies in its ability to precisely remove plaque while minimizing the risk of complications, backed by clinical evidence.