In the first step towards securing FDA approval, Israel-based device maker Magenta Medical is commencing an early feasibility study with its Elevate percutaneous Left Ventricular Assist Device (pLVAD) for high-risk percutaneous coronary intervention (HR-PCI).
Being the world’s smallest heart pump, it provides temporary mechanical circulatory support during HR-PCI procedures.
Patients with coronary artery disease often need a catheterisation procedure to open the arteries feeding the heart. In more serious, high-risk cases there may be instability during coronary intervention. In these cases, mechanical circulatory support is beneficial to preserve systemic blood pressure and maintain perfusion of vital organs, including the heart itself. Limiting the insertion profile of the device is particularly important to minimize vascular access complications.
Traditional LVAD devices are relatively large and require open heart surgery to be installed. However, the Elevate device can be inserted via a small puncture in the groin to be expanded when it reaches the heart’s left ventricle. The flow of the pump can be adjusted according to the needs of the patient up to 5 L/min of mean flow.
The first patient enrolled in the study by Dr. Samin Sharma, Director of Interventional Cardiology for the Mount Sinai Health System in New York City, underwent a high-risk procedure for severe three-vessel disease and received hemodynamic support by the Elevate system throughout the procedure.
“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 due to larger insertion sizes,” said Sharma.
The second patient enrolled by Dr. Richard Shlofmitz, Chairman of Cardiology at St. Francis Hospital and Heart Center in New York, underwent a complex PCI involving multiple vessels, resulting in a complete revascularization of the coronary tree. Robust hemodynamic support was provided throughout the procedure and weaning from the Elevate system was successfully performed in the catheterization laboratory.
In May, the company received $55m for its clinical programs.
“Magenta is proud to partner with top cardiology centers in the United States to further the validation of its technology and provide cardiologists with a powerful tool to support their high-risk patients during complex procedures,” said Magenta Medical CEO Dr. David Israeli. “We are looking forward to a speedy recruitment process and favourable study outcomes that would allow us to take the next step in the clinical program towards ultimate market approval.”