Magenta Medical announced today that it completed enrollment for the early feasibility study of its Elevate heart pump device.
The FDA-approved study evaluates the percutaneous left ventricular assist device (pLVAD) for high-risk percutaneous coronary intervention (HR-PCI). Investigators enrolled and successfully treated 15 study patients. Treatments took place at Mount Sinai Hospital, St. Francis Hospital and Heart Center and North Shore University Hospital.
Magenta won FDA approval to evaluate the safety and feasibility of Elevate in providing temporary mechanical support in HR-PCI procedures. It constitutes the first step in a clinical program aimed at securing approval for Elevate — the world’s smallest heart pump — in the U.S.
Dr. Samin Sharma, director of interventional cardiology at Mount Sinai, performed the first U.S. procedure. Sharma cited “three cardinal features” of Elevate — small insertion profile, ease of use and high pump flow. He said these enable surgeons to benefit many more appropriate selected complex PCI patients.
Sharma also noted the ability to navigate the device smoothly, despite hostile vascular environments.
More about the Magenta Medical miniature heart pump
Magenta’s high-flow, low-profile device holds a duo of FDA breakthrough device designations. The agency deemed it a breakthrough option for high-risk percutaneous coronary intervention and cardiogenic shock. Magenta completed a first-in-human study in Tbilisi, Georgia, and presented results last year.
The company now plans to launch clinical programs in the U.S., beginning with this early feasibility study. Earlier this year, Magenta raised $55 million in a financing round geared toward advancing these programs toward FDA approval.
The proprietary technology miniaturizes the powerful, percutaneous LVAD to fit an 8 Fr delivery system. Magenta says this marks the smallest crimping profile of any such device.
Inserted over a guidewire, through the aorta and across the aortic valve using 10 Fr introducer sheaths, the system offers ease of use, safety, physician access and vascular access closure. Once deployed, the speed of the pump can adjust to provide more than 5 L/min of mean blood flow at physiological blood pressures.
Magenta says that represents the full cardiac output of an adult. Its peak flows exceed 7 L/min, making it the most powerful known percutaneous pump.
“Magenta is honored to have partnered with top cardiology centers in the US to further validate its technology and provide cardiologists with a powerful tool to support their high-risk patients during complex procedures,” said Dr. David Israeli, CEO of Magenta Medical. “We are thrilled to have completed enrollment so quickly, which speaks to both the clinical need and the wonderful enthusiasm and support of our clinical partners. The Magenta team is looking forward to offering the advantages of the Elevate System to a wide range of complex cardiac patients in our expanding clinical program towards eventual market approval.”
