Magenta Elevate™ System

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 hospitalized with cardiogenic shock (CS).

The Elevate™ Pump is delivered sheathed into the LV through commercially available 10 Fr femoral introducer sheaths, fully over-the-wire (0.018”). Once placed in the LV, the self-expanding pump head is un-sheathed, expanding from 9 Fr to 30 Fr.

The Elevate™ Pump can deliver >5 L/min of mean flow from the LV to the ascending aorta (peak flow exceeds 7 L/min).

The Clinical Need

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 Technology Under the Hood

The self-expanding impeller is Magenta’s core 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 blood vessel and the expanded operating profile when deployed in the LV.

Clinical Experience

The Elevate™ System has been successfully evaluated in a First-in-Human study and a US Early Feasibility Study (EFS) of HR-PCI patients.

Regulatory Status

The Elevate™ System is not yet commercially available in any jurisdiction.