Magenta Medical Provides Update on Elevate pLVAD Early Feasibility Study

December 22, 2023—Magenta Medical’s Elevate percutaneous left ventricular assist device (pLVAD) is being evaluated in a United States early feasibility study (EFS).

In August, Magenta Medical announced the completion of enrollment to the FDA-approved EFS of the Elevate pLVAD for an indication of high-risk percutaneous coronary intervention (HR-PCI). In October, the company announced that the Elevate EFS met its objectives.

According to the company, the Elevate pLVAD system is designed to provide temporary mechanical circulatory support during HR-PCI procedures. It is a miniaturized heart pump that fits an 8-F delivery system. The pump can be inserted over a guidewire using a commercially available 10-F femoral introducer sheath—providing a small crimping profile. The flow of the pump is adjusted based on the clinical circumstances of the patient and can exceed 5 L/min of mean flow.

Elevate EFS investigator Perwaiz M. Meraj, MD, who is Director of the Cardiac Catheterization Laboratory at North Shore University Hospital (Northwell Health System) in Manhasset, New York, presented the results at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

All 15 patients enrolled in the study (mean age, 65 years) underwent a HR-PCI, with left ventricular ejection fraction of 35±10% at baseline and 45±11% at discharge.

As summarized by the company, key findings included the following:

• For performance, there were no hypotensive episodes. Mean arterial pressures were maintained well above 60 mmHg in all patients while on support.
• For technical success, delivery and extraction of all pumps was uneventful. Also, there were no device stoppages or replacements and no device-related complications.
• For safety, there was no new or worsening aortic regurgitation and no meaningful hemolysis. All patients were discharged alive and well and completed the 30-day follow-up visit. There were no major adverse cardiac and cerebrovascular events at 30 days.
• Regarding usability, the device’s ease of use was highly rated.
• For access, commercially available 10-F femoral sheaths were used.
• For closure, interventionists used a variety of pre- and post-closure techniques.

Magenta Medical advised that Elevate is an investigational device, limited by federal law to investigational use only. The technology was awarded FDA Breakthrough Device designation for two indications: HR-PCI and cardiogenic shock.