First CE Mark for Less-Invasive HVAD Implant Procedure

Medtronic plc has announced that its HVAD System left ventricular assist device (LVAD) received CE (Conformité Européenne) Mark for a less-invasive implant procedure in patients with advanced heart failure. The HVAD System is the only centrifugal LVAD approved in the European Union for implantation via this new thoracotomy procedure.
 
Compared to the standard LVAD surgical implant technique, the new approach uses a smaller incision^1,2, potentially lessens surgical bleeding^1,3 and related blood transfusions¹, potentially reduces the development of right heart failure^1,4, and may result in shorter hospital stays⁵. The thoracotomy implantation technique may allow the area around the heart to remain largely intact, potentially preserving the sternum for future procedures or a heart transplant.¹
 
“The HVAD System’s small size makes it well-suited for routine thoracotomy implantation,” said Jan Schmitto, M.D., Ph.D., director of the Mechanical Circulatory Support Program and cardiothoracic surgeon at Hannover Medical School, Hannover, Germany, which helped pioneer the new procedure. “This less-invasive implant procedure potentially enables faster patient recovery compared to the traditional approach, which may help improve patient outcomes.”
 
The HVAD System features the HVAD Pump, which is smaller than other commercially available devices, and which more easily enables implantation through a small, lateral thoracotomy incision between a patient’s ribs on the left side of the chest.
 
“The HVAD System is the only full-support, centrifugal LVAD approved in Europe for thoracotomy implantation, providing clinicians with greater freedom to choose the best surgical technique for each patient,” said David Steinhaus, M.D., vice president and general manager of the Heart Failure business, and medical director of the Cardiac Rhythm and Heart Failure division at Medtronic. “CE Mark for the thoracotomy procedure is a testament to the HVAD System’s flexibility and versatility, and may enable more patients to receive the life-sustaining benefit of the device for the treatment of advanced heart failure.”
 
A study of the thoracotomy HVAD procedure is underway in Canada and the U.S., where the implant procedure currently is not approved. The Lateral Study is the largest prospective clinical trial of a full-support ventricular assist device (VAD) to evaluate this implant technique. The study includes patients with end-stage heart failure who have not responded to standard medical management and who are eligible for heart transplantation.
 
The HVAD System features the world’s smallest, full-support centrifugal circulatory assist device, the HVAD Pump, which is designed to be implanted next to the heart in the pericardial space. The HVAD System received CE Mark in the European Union in 2009, and was approved by the U.S. Food and Drug Administration in 2012 as a bridge to cardiac transplantation for patients who are at risk of death from refractory end-stage left ventricular heart failure. Today, more than 11,000 patients with advanced heart failure have received the HVAD System.
 
The Medtronic heart failure portfolio includes leading cardiac resynchronization therapies, including the first MR-conditional CRT-defibrillators in the U.S., mechanical circulatory support therapy and impactful heart failure diagnostics and expert analysis through Medtronic Care Management Services.
 
References
¹ Schmitto, J. Implantation of a centrifugal pump as a left ventricular assist device through a novel, minimized approach: Upper hemisternotomy combined with anterolateral thoracotomy. J Thorac Cardiovasc Surg 2012;143:511-513.
² Deuse, T. and Reichenspurner, H. Do Not Touch the Sternum-Thoracotomy Incisions for HVAD Implantation. ASAIO Journal 2014;60:234-236.
³ Popov, AR. HeartWare left ventricular assist device implantation through bilateral anterior thoracotomy. Ann Thorac Surg 2012;93:674-6.
⁴ Meyer, AL.Minimal-invasive LVAD implantation, is it safe or even better? J Heart Lung Transplant 2013;32.
⁵ Rojas, S. Chronic ventricular assist device support: surgical innovation. Curr Opin Cardiol 2016;31:308-213.