A Medical Device Daily

WorldHeart (Oakland, California), a developer of mechanical circulatory support systems, reported that the first patient implanted with its ventricular assist device (VAD) went home last week. He was discharged from the hospital after the VAD was explanted, having recovered sufficient cardiac function to restore him to a good quality of life.

In early March, the rotary VAD was implanted into the 67-year-old man with end-stage, Class IV heart failure, as part of an operation that included heart repair and VAD support. The surgery, performed at St. Luke's Hospital (Thessaloniki, Greece), marked the start of the feasibility clinical trial of WorldHeart's next-generation rotary VAD.

Since then, a second patient has been successfully implanted with the rotary VAD and continues to recover.

“The very positive clinical outcome for the first patient more than met our expectations for the trial,” said Dr. Antonis Pitsis, principal investigator from St. Luke's Hospital. “While supported by the VAD, he regained cardiac functionality such that he no longer requires mechanical ventricular assistance.”

WorldHeart President and CEO Jal Jassawalla said, “We are extremely pleased with the way our device is performing in this European feasibility trial, and look forward to initiating a United States trial currently planned for early next year.”

WorldHeart's strategy is to provide reliable, long-term mechanical circulatory support to the broadest population of heart failure patients. The company is developing both pulsatile VADs, which mimic the action of the natural heart, as well as the continuous flow rotary VAD, which is smaller and more easily implanted.

The rotary VAD is the only bearingless, fully magnetically levitated implantable centrifugal rotary pump in clinical trials. It is an advanced, next-generation, continuous-flow pump that uses magnetic levitation to fully suspend the spinning impeller, its only moving part, inside a compact housing.

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