The implantation, part of a European trial designed to examine less-invasive procedures such as hemi-sternotomy and left thoracotomy, was the 1st of a planned 10 surgeries, Pleasanton, Calif.-based Thoratec said.
“This achievement marks the latest step in our progress with HeartMate III, and will help build important clinical experience as we validate the surgical versatility of this exciting new technology,” president & CEO Keith Grossman said in prepared remarks.
The 1st mini-thoracotomy was performed by Drs. Ivan Netuka and Jan Schmitto at Prague’s Institute for Clinical and Experimental Medicine, Thoratec said.
“The pump design ensured elegant placement in a petite 70-year-old female with body surface area of 1.65 m2, and the patient has been discharged from the hospital in a normal post-operative manner. This demonstrates that HeartMate 3 can accommodate choice in surgical placement. We look forward to confirming an encouraging initial experience in this ongoing trial,” Netuka said.
“The ease of implant, combined with potential for improved clinical outcomes with HeartMate 3, provide for a very attractive next generation device capable of treating a wide range of patients,” Schmitto added.
In December 2014 Thoratec closed enrollment in a 50-patient clinical trial of its HeartMate III left ventricular assist device it hopes will lead to CE Mark approval in the European Union.
In April the FDA approved an expansion of a U.S. investigational device exemption trial for the HeartMate III device to as many as 1,028 patients at up to 60 sites.