First patients treated in the US with the world's smallest heart pump
Press releases may be edited for formatting or style | June 08, 2023
Cardiology
KADIMA, Israel, June 7, 2023 /PRNewswire/ -- Magenta Medical, developer of the world's smallest heart pump, announced today the initiation of its FDA-approved Early Feasibility Study with the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) for the high-risk percutaneous coronary intervention (HR-PCI) indication. The study began with the treatment of two patients: one in Mount Sinai Health System and one in St. Francis Hospital and Heart Center, both in New York.
Patients with coronary artery disease are often referred to a catheterization procedure to open blockages in the arteries feeding the heart, with the goal of improving their quality-of-life and reducing the risk of heart attacks. Some of these patients present with more severe disease, making them prone to instability during coronary intervention, and are thus categorized as high-risk. In these patients, it is advantageous to provide mechanical circulatory support during the procedure to preserve systemic blood pressure and maintain perfusion of vital organs, including the heart itself. Since the duration of support for this indication is typically short (up to 6 hours), with patients ambulatory soon following the procedure, it is particularly important to limit the insertion profile of the device in order to minimize vascular access complications.
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. The percutaneous Elevate™ heart pump is inserted over a guidewire through commercially available 10 Fr introducer sheaths that require a small puncture in the groin. The flow of the pump is adjusted based on the clinical circumstances of the patient, up to 5 L/min of mean flow, making it the most powerful pump of its kind.
The Elevate™ Early Feasibility Study was approved by the FDA to evaluate the safety and feasibility of the Elevate™ system in providing temporary mechanical circulatory support during HR-PCI procedures, and constitutes the first step in a clinical program intended to secure approval for the device in the US for this indication.
The first patient was enrolled in the study by Dr. Samin Sharma, Director of Interventional Cardiology for the Mount Sinai Health System in New York City. The patient underwent a high-risk procedure for severe three-vessel disease and received hemodynamic support by the Elevate™ system throughout the procedure.
Patients with coronary artery disease are often referred to a catheterization procedure to open blockages in the arteries feeding the heart, with the goal of improving their quality-of-life and reducing the risk of heart attacks. Some of these patients present with more severe disease, making them prone to instability during coronary intervention, and are thus categorized as high-risk. In these patients, it is advantageous to provide mechanical circulatory support during the procedure to preserve systemic blood pressure and maintain perfusion of vital organs, including the heart itself. Since the duration of support for this indication is typically short (up to 6 hours), with patients ambulatory soon following the procedure, it is particularly important to limit the insertion profile of the device in order to minimize vascular access complications.
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. The percutaneous Elevate™ heart pump is inserted over a guidewire through commercially available 10 Fr introducer sheaths that require a small puncture in the groin. The flow of the pump is adjusted based on the clinical circumstances of the patient, up to 5 L/min of mean flow, making it the most powerful pump of its kind.
The Elevate™ Early Feasibility Study was approved by the FDA to evaluate the safety and feasibility of the Elevate™ system in providing temporary mechanical circulatory support during HR-PCI procedures, and constitutes the first step in a clinical program intended to secure approval for the device in the US for this indication.
The first patient was enrolled in the study by Dr. Samin Sharma, Director of Interventional Cardiology for the Mount Sinai Health System in New York City. The patient underwent a high-risk procedure for severe three-vessel disease and received hemodynamic support by the Elevate™ system throughout the procedure.
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