Officials at World Heart Corp. (NSDQ:WHRT) officially pulled the plug on clinical trials of the company’s Levacor ventricular assist device (VAD) technology and laid off nearly half its workforce.
The Salt Lake City-based company will layoff 21 of its 50 employees, according to World Heart CFO Morgan Brown, as it looks to reorganize its efforts behind a new device called the MiFlow, which Brown told MassDevice is essentially an adult-sized version of the company’s PediaFlow, a small, magnetically levitated, rotary pediatric ventricular assist device that is intended for use in newborns and infants.
The company is working with a consortium consisting of the University of Pittsburgh, Children’s Hospital of Pittsburgh, Carnegie Mellon University and LaunchPoint Technologies Inc. to develop the PediaFlow, which received a Humanitarian Device Exemption from the Food & Drug Administration in February 2011.
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Brown said World Heart had been conducting clinical trials of its Levacor devices, a magnetically levitated, bearingless, implantable centrifugal pump up until February 2011, when the company decided to pause enrollment of the study to make refinements to the device based on initial clinical experience.
However, the company warned investors in May that in light of ongoing communications with the FDA, “the timeline for implementation of these refinements is dependent on review and approval by the FDA.”
Brown said it was apparent in the company’s conversations that as the company went through the process with the FDA that internal timelines were not going to be met.
“It became increasingly clear that as we went down process timelines we were hoping for were not going to be achieved and we were going to be delayed significantly,” Brown told us.
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He added that given the competitive landscape and the unclear timelines, company officials felt that “moving away [from Levacor] was the best course of action.
Brown said he expected the MiFlow to be in animal studies by early 2012 and in human clinical trials in Europe by 2013.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
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