Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe

Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe https://www.taxtmi.com/news?id=51427 FDA Investigational Device Exemption approval enabled initiation of the MAGICAL SV prospective, multicenter, single blind randomized trial comparing Concept Medical's MagicTouch sirolimus coated balloon to drug eluting stents for small coronary artery lesions. The protocol uses two to one randomization with stratification by site and diabetes status and identifies target lesion failure at twelve months as the primary endpoint. The multicontinental study aims to produce comparative safety and efficacy evidence to support a Pre Market Approval application for the device's small vessel indication. en-us Mon, 04 Aug 2025 12:16:03 +0530 Mon, 04 Aug 2025 12:16:03 +0530 TaxTMI RSS Generator Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe https://www.taxtmi.com/news?id=51427 FDA Investigational Device Exemption approval enabled initiation of the MAGICAL SV prospective, multicenter, single blind randomized trial comparing Concept Medical's MagicTouch sirolimus coated balloon to drug eluting stents for small coronary artery lesions. The protocol uses two to one randomization with stratification by site and diabetes status and identifies target lesion failure at twelve months as the primary endpoint. The multicontinental study aims to produce comparative safety and efficacy evidence to support a Pre Market Approval application for the device's small vessel indication. News - Mon, 04 Aug 2025 12:16:03 +0530 https://www.taxtmi.com/news?id=51427