HeartWare International has completed the enrolment of patients in the Lateral study of the HeartWare ventricular assist system (HVAD system).
Lateral is a US investigational Device Exemption (IDE) prospective clinical trial that will evaluate the clinical outcomes of patients withend-stage heart failure who are awaiting a heart transplant, and are implanted with the HVAD pump through a less-invasive thoracotomy procedure.
It is a prospective, multicenter and single-arm clinical trial, which was designed to recruit around 145 patients at about 30 hospitals in North America.
HeartWare president and CEO Doug Godshall said: "The Lateral study represents one of our key initiatives to leverage the versatility of the HVAD pump’s compact size into clinical benefits for the physician, patient and payer.
"We would like to thank the investigators, coordinators and entire heart team at each hospital site participating in this trial, as well as the cardiovascular surgeons for investing the resources necessary to learn and implement a new, promising surgical implant technique."
The HVAD system includes HVAD pump that allows implantation through a small and lateral thoracotomy incision between the patient’s ribs on the left side of the chest.
HeartWare system secured CE mark approval in the European Union in 2009, approval from 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.
In addition, the device is currently the subject of a US clinical trial for destination therapy.
Image: Lateral is a US IDE prospective clinical trial that will assess the clinical outcomes of patients with end-stage heart failure. Photo: courtesy of dream designs / FreeDigitalPhotos.net.