Magenta Medical’s Elevate Early Feasibility Study Completes Enrollment

August 31, 2023—Magenta Medical recently announced the completion of enrollment to its FDA-approved early feasibility study (EFS) with the company’s Elevate percutaneous left ventricular assist device (pLVAD) for the high-risk percutaneous coronary intervention (HR-PCI) indication. All 15 study patients were enrolled and successfully treated at Mount Sinai Hospital in New York, New York; St. Francis Hospital and Heart Center in Roslyn, New York; and North Shore University Hospital in Manhasset, New York.

According to the company, the Elevate EFS, which commenced enrollment in June 2023, was approved by the FDA to evaluate the safety and feasibility of the Elevate system in providing temporary mechanical circulatory support during HR-PCI procedures. The study constitutes the first step in a clinical program intended to secure approval for the device in the United States for this indication.

Magenta Medical stated that its 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 that require a small puncture in the groin. The flow of the pump is adjusted based on the clinical circumstances of the patient, with the ability to surpass 5 L/min of mean flow. Elevate is an investigational device, limited by Federal law to investigational use only. The technology received Breakthrough Device designation from the FDA for two indications: HR-PCI and cardiogenic shock, advised the company.

The first procedure in the Elevate EFS was performed by Samin Sharma, MD, Director of Interventional Cardiology at the Mount Sinai Health System. Dr. Sharma was the top enroller in this series.

The last patient in this series was treated at North Shore University Hospital by Rajiv Jauhar, MD, Chief of Cardiology, and Perwaiz M. Meraj, MD, Director of the Cardiac Catheterization Laboratory.

“Having now used the system in nine complex, HR-PCI cases, I can truly appreciate its advantages,” commented Dr. Sharma in the company’s press release. “As I see it, 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. Elevate is advanced over the wire, fully crimped and covered. This makes it possible to navigate the device smoothly even through hostile vascular environments, which is very important, as atherosclerosis affects the entire arterial tree.”

In the last case performed at North Shore, the patient had severe generalized atherosclerosis with an abdominal aortic aneurysm, three-vessel coronary artery disease, and severely depressed left ventricular function.

Dr. Jauhar performed prolonged and extensive rotablation of a sub-totally occluded, heavily calcified left anterior descending artery that provided collaterals to a totally occluded right coronary artery, followed by stenting and intravascular ultrasound-guided lithotripsy.

In Magenta Medical’s press release, Dr. Jauhar state, “This was a very challenging case, and I strongly feel that without Elevate’s support, it would not have been possible to perform the procedure safely. This device is very easy to use, is delivered through a true 10-F sheath, and provides terrific support. We were able to safely pass the aneurysm, quickly position the device, and perform extensive revascularization, employing a variety of lesion-appropriate treatment modalities under full hemodynamic support, and all in under 1 hour.”