Magenta Medical, developer of the world’s smallest heart pump, announced today the completion of enrollment to its FDA-approved Early Feasibility Study with the 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, St. Francis Hospital and Heart Center, and North Shore University Hospital. The Elevate™ Early Feasibility Study 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, and constitutes the first step in a clinical program intended to secure approval for the device in the US for this indication.
Dr. Samin Sharma, Director of Interventional Cardiology at the Mount Sinai Health System in New York City, performed the first US procedure and was also the top enroller in this series. “Having now used the system in nine complex, high-risk PCI cases, I can truly appreciate its advantages,” said Dr. Sharma. “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.”
Mechanical circulatory support is often necessary for high-risk patients with coronary artery disease undergoing a catheterization procedure to open blockages in the arteries feeding the heart to improve quality of life and reduce the risk of heart attacks. Since the duration of support for this indication is typically short (up to 6 hours), with patients ambulatory soon following the procedure, it is particularly important to limit the insertion profile of the device in order to minimize vascular access complications.
Having secured FDA Breakthrough Device Designation, Magenta Medical’s proprietary technology miniaturizes a powerful blood pump to fit an 8 Fr delivery system – the smallest crimping profile of any such device. The percutaneous Elevate™ heart pump is inserted over a guidewire through commercially available 10 Fr 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, making it the most powerful pump of its kind.
The last patient in this series was treated by Dr. Rajiv Jauhar, Chief of Cardiology, and Dr. Perwaiz M. Meraj, Director of the Cardiac Catheterization Laboratory – both at North Shore University Hospital (Northwell Health System). The patient had severe generalized atherosclerosis with an abdominal aortic aneurysm, 3-vessel coronary artery disease, and severely depressed left ventricular function. Dr. Jauhar performed prolonged and extensive rotablation of a sub-totally occluded, heavily calcified LAD that provided collaterals to a totally occluded right coronary artery, followed by stenting, and IVUS-guided lithotripsy.
Speaking about his experience, Dr. Jauhar said: “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 French 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 one hour.”
“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.”
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: high-risk percutaneous coronary intervention and cardiogenic shock.