HeartWare International, Inc. (HTWR)

[cjgaddy]

1-13-15: 1st Pt. Implanted in HVAD MEDIAN STERNOTOMY Trial
"HeartWare Begins HVAD LATERAL Study, A Clinical Trial Of Advanced Heart Failure Patients Implanted Via Less-Invasive Thoracotomy Technique"
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=2007206

FRAMINGHAM Jan. 13, 2015: HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced the first patient implant in the HVAD LATERAL Study, a U.S. Investigational Device Exemption (IDE) clinical trial in which the HeartWare Ventricular Assist System, featuring the HVAD Pump, is implanted through a less-invasive thoracotomy procedure in patients with end-stage heart failure who are awaiting a heart transplant.

The HVAD LATERAL Study is designed to study the clinical outcomes of this surgical technique. Currently, commercially available ventricular assist systems are only approved by the U.S. FDA for use with implantation via median sternotomy, a common surgical approach in cardiac surgery which utilizes a vertical incision through the center of the patient's chest. With the less-invasive thoracotomy approach, the HVAD® Pump, which is smaller than other contemporary devices, is implanted using a small lateral thoracotomy incision between the patient's ribs on the left side of the chest.

"The thoracotomy implant technique holds considerable promise for making implantation easier for the surgeon and better tolerated by the patient," said Ed McGee, M.D., head of the heart transplant and assist device program and a professor in the Dept of Thoracic and Cardiovascular Surgery at Loyola Univ. Chicago Stritch School of Medicine, and a Co-Principal Investigator for the HVAD LATERAL Study. "Implantation via thoracotomy allows for preservation of a sternotomy for a heart transplant, making that subsequent surgery less difficult for the bridge-to-transplant patient.". . .