A Medical Device Daily

Ventracor (Sydney, Australia) reported that the FDA has approved the company’s request to allow home discharge of patients implanted with the VentrAssist left ventricular assist system under the U.S. feasibility trial.

“Until now, U.S. VentrAssist patients have been required to remain in hospital or an intermediate care facility until heart transplant,” said CEO Peter Crosby. “Removing this requirement makes participation in the U.S. feasibility trial more attractive to patients because they are able to return to their home once they are discharged by their physician. We expect this approval will be a catalyst for recruitment in coming weeks, and is a key step on the path towards meeting our previously announced milestone of commencement of enrollment in the U.S. bridge-to-transplant pivotal trial in early 2007.”

The FDA approval is conditional on the company making amendments to the labeling of the VentrAssist within 45 days; however, the ability for patients to be discharged home is immediate, the company said.

Ventracor is currently developing the VentrAssist as therapy for patients in end-stage heart failure.