Clinical Experience
Regulatory Status
The Elevate™ System is not yet commercially available in any jurisdiction.
The Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) is a self-expanding percutaneous heart pump, intended to provide temporary mechanical circulatory support for the left ventricle (LV) during high-risk percutaneous coronary interventions (HR-PCI) and in patients admitted with cardiogenic shock (CS).
The Elevate™ Pump is delivered sheathed into the LV through any number of commercially available 10 Fr femoral introducer sheaths, fully over-the-wire (0.018”). Once in the LV, the self-expanding pump is un-sheathed, expanding from 9 Fr to 30 Fr.
The Elevate™ Pump can deliver >5.4 L/min of mean flow from the LV to the ascending aorta (peak flow exceeds 8 L/min).
During HR-PCI and CS, the LV may require support in pumping oxygenated blood from the ventricle into the aorta, so that adequate cardiac output, arterial blood pressure and coronary and end-organ perfusion could be maintained for up to several days. The pump unloads the LV by reducing both its pressure and volume, thus decreasing wall stress, mechanical work, and overall myocardial oxygen consumption.
The self-expanding impeller is the the core of Magenta’s technology. It is comprised of a thin shape-memory metallic frame and a soft, elastic material that forms the body of the blades.
During the crimping process, the impeller is elongated and its diameter reduced, allowing for a 3.5x diameter expansion between the crimped profile during insertion into the patient’s vasculature and the expanded operating profile when deployed inside the LV.
The Elevate™ System is not yet commercially available in any jurisdiction.