Magenta Medical’s Elevate pLVAD Evaluated in Early Feasibility Study

June 7, 2023—Magenta Medical, an Israel-based medical device company, announced the initiation of its FDA-approved early feasibility study (EFS) with the Elevate percutaneous left ventricular assist device (pLVAD) for an indication of high-risk percutaneous coronary intervention (HR-PCI).

The Elevate EFS was approved by the FDA to evaluate the safety and feasibility of the Elevate system in providing temporary mechanical circulatory support during HR-PCI. The Elevate clinical program is intended to secure approval for the device in the United States for this indication. Elevate, which is limited by Federal law to investigational use only, received FDA Breakthrough Device designation for two indications: HR-PCI and cardiogenic shock, advised the company.

According to Magenta Medical, the company’s technology miniaturizes a powerful blood pump to fit an 8-F delivery system. The percutaneous Elevate heart pump is inserted over a guidewire through commercially available 10-F introducer sheaths, requiring 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.

The first patient enrolled in the study was treated by Samin Sharma, MD, Director of Interventional Cardiology for the Mount Sinai Health System in New York, New York. The patient underwent a high-risk procedure for severe three-vessel disease and received hemodynamic support by the Elevate system throughout the procedure.

“I am delighted to be partnering with Magenta Medical on this study,” commented Dr. Sharma in the company’s press release. “The three cardinal features of the Elevate pLVAD—small insertion profile, ease of use, and high pump flow—will enable us to benefit many more appropriately selected complex PCI patients, where current devices are limited due to larger insertion sizes.”

The second patient was enrolled by Richard Shlofmitz, MD, Chairman of Cardiology at St. Francis Hospital and Heart Center in Roslyn, New York. The patient also underwent a complex PCI involving multiple vessels, resulting in a complete revascularization of the coronary tree. Hemodynamic support was provided throughout the procedure and weaning from the Elevate system was successfully performed in the catheterization laboratory.

Dr. Shlofmitz stated in the company’s press release, “As a recognized leader in cardiovascular research, St. Francis is thrilled to be a part of this study. We are excited about the prospects of the Elevate system given the unique combination of simplicity, attractive insertion profile, and the full hemodynamic support the pump can provide.”

Dr. Shlofmitz added, “In a busy practice such as ours that promotes clinical excellence with unwavering patient safety, the Elevate system could have a significant impact on patient outcomes.”