Medtronic‘s HeartWare HVAD system, a left ventricular assist device, has been approved by the FDA as a “destination therapy” for those with advanced heart failure that cannot receive a transplanted heart. The HeartWare HVAD heart pump is a centrifugal flow device that augments blood from the left ventricle into the body, alleviating the natural heart from having to produce all the cardiac outpu on its own. Earlier this year we interviewed Dr. David Steinhaus, Vice President and General Manager of Medtronic’s Heart Failure division, about a recent trial of the device.
The device received approval from the FDA in 2012 as a bridge to heart transplantation, giving patients more time to wait for a heart to become available. It has already been used in more than 13,000 patients in almost 50 countries worldwide.
From Medtronic:
FDA approval is based on results from the ENDURANCE and ENDURANCE Supplemental trials, which enrolled nearly 1,000 destination therapy patients. The data support the safety and effectiveness of the HeartWare HVAD System for patients with advanced, refractory left ventricular heart failure as a bridge to cardiac transplantation (BTT), or myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned.
Flashbacks: Early Success in HVAD LATERAL Trial: Interview with Medtronic’s Dr. David Steinhaus, M.D., Vice President and General Manager…; HeartWare Ventricular Assist System Receives FDA Approval as Bridge to Heart Transplantation…; Medical Heart Pumps from HeartWare: HVAD, MVAD and PedVAD…; HeartWare Heart Pump Shows Positive Results in Clinical Study…; HeartWare LVADs Get FDA Nod for More Trials…
Product page: HeartWare HVAD…
Via: Medtronic…
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