Irish medical technology firm Medtronic has received CE mark approval for its HVAD System left ventricular assist device (LVAD) for a less-invasive implant procedure in patients with advanced heart failure.
The HVAD system is claimed to be the only centrifugal LVAD approved in the European Union for implantation through new thoracotomy procedure.
Featuring HVAD pump, the system allows implantation through a small and lateral thoracotomy incision between a patient's ribs on the left side of the chest.
The new approach uses smaller incision compared against the standard LVAD surgical implant technique, as well as reduces surgical bleeding and related blood transfusions. It also helps to reduce the development of right heart failure.
The company is currently carrying out a study on the thoracotomy HVAD procedure in Canada and the US. It is claimed to be the largest prospective clinical trial of a full-support ventricular assist device (VAD) to evaluate this implant technique.
The study is comprised of patients with end-stage heart failure who have not responded to standard medical management and who are eligible for heart transplantation.
HVAD, which first secured CE mark approval in 2009, was also approved by the US 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.
Medtronic heart failure business general manager and vice president Dr David Steinhaus said: "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.
“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."