Magenta Medical has advanced a step closer to regulatory approval for its Elevate heart pump system, after the company announced it had completed enrolment in an early feasibility study for the device.
Elevate – dubbed by Magenta as the ‘world’s smallest heart pump’ – was used in 15 patients to provide temporary mechanical circulatory support during high-risk percutaneous coronary intervention (HR-PCI) procedures. Magenta’s percutaneous Left Ventricular Assist Device (pLVAD) is inserted over a guidewire through sheaths via the groin. According to the Israel-based company, it has developed technology that “miniaturises a powerful blood pump to fit an 8 Fr delivery system – the smallest crimping profile of any such device”.
The size of Magenta’s device means it can be applied less invasively, compared to the larger traditional LVADs which usually require open heart surgery.
The US Food and Drug Administration (FDA) approved the use of the Elevate in an Early Feasibility Study, which commenced in mid-June 2023.
The trial (NCT05727059) is a prospective, single-arm, multi-centre, interventional study. Primary outcome measures are the rate of major device-related adverse events and how successful the device is in providing haemodynamic support. Both these outcomes are assessed from device insertion to removal, a period of up to six hours.
Analysis by GlobalData estimates that the LVAD device market will reach $2.24bn by 2033, as heart failure prevalence continues to rise.
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Dr. Samin Sharma, Director of Interventional Cardiology at the Mount Sinai Health System in New York City, who performed the first US procedure, said: “Having now used the system in nine complex, high-risk PCI cases, I can truly appreciate its advantages.”
“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 May 2023, the company raised $55m to help fund clinical programmes for the device.