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- G220308-NCT05727059 | CMS
Early Feasibility Study (EFS) of the Magenta Elevate ™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions
- Magenta Medical Reports Positive Results for US Early Feasibility Study . . .
Elevate™ Pump flow was increased (mean of 5 7-5 9 L min), allowing placement of a trans-venous temporary pacemaker under stable hemodynamic conditions
- Magenta Medical Completes Enrollment to Early Feasibility . . . - BioSpace
Magenta Medical, developer of the world’s smallest heart pump, announced the completion of enrollment to its FDA-approved Early Feasibility Study with the Elevate™ percutaneous Left Ventricular Assist Device for the high-risk percutaneous coronary intervention indication
- Magenta Elevate™ EFS in High-Risk PCI Patients - ICH GCP
The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease
- Initial results promising for worlds smallest percutaneous heart pump
A new percutaneous left ventricular assist device (pVAD), the Magenta Elevate, may offer a next step with with the smallest catheter size yet to be used in a first-in-human trial The Elevate uses a 10 French catheter, while the current standard of the Abiomed Impella is 14 French
- Magenta Medical, Developer of Elevate Heart Pump System - an FDA . . .
Having secured FDA Breakthrough Device Designation, Magenta Medical’s proprietary technology miniaturizes a powerful blood pump to fit an 8 Fr delivery system - the smallest crimping profile of any such device
- Magenta Medical Looks to Secure Place in MCS Market - MDDI Online
Magenta Medical wants to disrupt the mechanical circulatory support (MCS) market with the Elevate Percutaneous Left Ventricular Assist Device (pLVAD) The Kadima, Israel-based company is developing Elevate, which would go head-to-head with Johnson Johnson’s Impella heart pump – the most dominant player in the space
- Magenta Medical Provides Update on Elevate pLVAD Early Feasibility . . .
December 22, 2023—Magenta Medical’s Elevate percutaneous left ventricular assist device (pLVAD) is being evaluated in a United States early feasibility study (EFS) In August, Magenta Medical announced the completion of enrollment to the FDA-approved EFS of the Elevate pLVAD for an indication of high-risk percutaneous coronary intervention
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