Will Magenta Medical’s Elevate Disrupt the MCS Market?Will Magenta Medical’s Elevate Disrupt the MCS Market?

Magenta Medical wants to disrupt the mechanical circulatory support (MCS) market with the Elevate Percutaneous Left Ventricular Assist Device (pLVAD).

The Kadima, Israel-based company is developing Elevate, which would go head-to-head with Johnson & Johnson’s Impella heart pump – the most dominant player in the space. New Brunswick, NJ-based Johnson & Johnson inherited the Impella heart pump when it acquired Abiomed in 2022 for $16.6 billion. (Editor’s note: Abiomed acquired the device when it agreed to buy Impella CardioSystems in 2005.)

“[Johnson & Johnson’s Abiomed] is the benchmark for competition and market size,” David Israeli, MD, Magenta’s CEO, told MD+DI. “It’s a very significant market and it has a lot of room to grow.”

Elevate has the potential to stand out from Impella because of the smaller insertion size and the higher flow.

“There’s always room for ‘me-too’ devices, but this isn’t the Magenta story – it’s anything but,” Israeli said. “We set out to disrupt the field, and we’re doing this with two main advantages: insertion size and blood flow. When interventional cardiologists insert devices into the patient’s circulation, they really want to make sure that they are using the least invasive technique possible, i.e., they try to minimize the size of the puncture in the main artery of the groin. This, in turn, would translate into less complications and less bleeding events. Minimizing access site complications is really impactful for the clinician as an operator, and, obviously, it’s very impactful to the patient from a safety profile perspective. The Magenta Elevate device is compatible with any number of commercially available 10 Fr introducer sheaths, whereas Abiomed’s ‘workhorse’ (Impella CP) is rated at 14 Fr.”

Related:Abiomed to Acquire Impella

How Elevate Works

Magenta said the Elevate pump is first folded and then inserted percutaneously through a small puncture in the groin to accommodate a commercially available 10 Fr introducer sheath. The pump is delivered into the heart fully sheathed, over a guidewire, through the aorta, and across the aortic valve.

Employing standard catheterization techniques and equipment for placement provides important advantages in terms of ease-of-use, safety, physician access, and vascular access closure.

Before activation, the device self-expands inside the heart, and the flow through the pump is adjusted based on the clinical circumstances of the patient, up to the entire cardiac output of an adult (> 5 L/min of mean flow at physiological blood pressures). This allows the heart to rest and the patient to recover.

Related:Johnson & Johnson to Buy Abiomed for $16.6B

Investors Understand Magenta’s Assignment

The company said last month that it closed a $105 million financing round led by Novo Holdings. New investors Viking Global Investors and RA Capital Management, and existing investors OrbiMed, New Enterprise Associates (NEA), JVC Investment Partners, and ALIVE - Israel HealthTech Fund, also participated in this round.

"Magenta's technology stands at the forefront of innovation in the MCS field and has the potential to significantly improve outcomes in patients with severe cardiovascular conditions," said Eric Snyder, Partner, Venture Investments, Novo Holdings US. "We look forward to supporting Magenta's team in bringing better care to even more patients in need of mechanical circulatory support."

The company said the financing would be used to support FDA approval for Elevate in patients undergoing high-risk percutaneous coronary interventions and advancing clinical trials with the cardiogenic shock indication.

“Elevate is a new participant in the temporary MCS market, and this space is essentially split into two major indications,” Israeli said. “One currently approved indication is high-risk percutaneous coronary interventions (PCI), and it includes patients who are referred for high-risk cardiac catheterization procedures. There are more than a million of these procedures every year in the United States, and about 10% to 15% of those are characterized as high-risk based on disease burden, or the extent of the disease in the coronary tree.”

Israeli added, “When these patients are referred to a cardiac catheterization procedure - if they meet the high-risk criteria, then they would be eligible to receive a pump on a temporary basis to provide circulatory support for the heart while arteries are being opened as part of the procedure. This is the first indication that Magenta is pursuing.”

Israeli said, “On the heels of this indication, we’re going to pursue the second approved indication, which requires longer support. Patients admitted with cardiogenic shock - meaning acute, abrupt reduction in left ventricular function - typically require immediate mechanical circulatory support as a life-saving measure until their heart recoups to the point when they can be weaned from the pump and discharged home with their native heart. This usually takes several days.”

Magenta completed a U.S. Early Feasibility Study with the high-risk PCI indication in 2023. The results were presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco by Dr. Perwaiz Meraj of North Shore University Hospital.