World's Smallest Heart Pump Helps Cardiologists Support High-Risk Patients during Complex Procedures
Posted on 08 Jun 2023
Patients suffering from coronary artery disease often undergo a catheterization procedure to clear blocked arteries that supply the heart, with the intent of enhancing their quality of life and decreasing the risk of heart attacks. However, patients with more severe conditions may experience instability during the coronary intervention, thus making them high-risk patients. For such patients, mechanical circulatory support during the procedure is beneficial to maintain systemic blood pressure and ensure the perfusion of essential organs, including the heart itself. Given that the support duration for such a case is typically short (up to 6 hours), with patients becoming mobile shortly after the procedure, it's crucial to minimize the device insertion profile to reduce vascular access complications. To address this, new technology has now miniaturized a robust blood pump to fit an 8 Fr delivery system, the smallest crimping profile for any device of its kind.
Magenta Medical’s (Kadima, Israel) percutaneous Elevate heart pump can be inserted over a guidewire through commercially available 10 Fr introducer sheaths that necessitate a small groin puncture. The pump's flow can be adjusted based on the patient's clinical situation, offering up to 5 L/min of mean flow, making it the most powerful pump in its class. The FDA has granted the Elevate device Breakthrough Device Designation for two indications - high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock. Magenta has started the initial phase of its FDA-approved Early Feasibility Study with the Elevate percutaneous Left Ventricular Assist Device (pLVAD) for the HR-PCI indication. The FDA has approved the Elevate Early Feasibility Study to evaluate the safety and feasibility of the Elevate system in providing temporary mechanical circulatory support during HR-PCI procedures. This study marks the first step in a clinical program designed to secure approval for the device in the US for this indication.
"Magenta is proud to partner with top cardiology centers in the United States to further the validation of its technology and provide cardiologists with a powerful tool to support their high-risk patients during complex procedures," said Dr. David Israeli, CEO of Magenta Medical. "We are looking forward to a speedy recruitment process and favorable study outcomes that would allow us to take the next step in the clinical program towards ultimate market approval."
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