FDA Approves Feasibility Study for Ventracor Heart Device in U.S.

International medical technology company Ventracor has received conditional approval from the FDA for a feasibility study of its cardiac assist device in the U.S.

"The FDA has given Ventracor conditional approval to begin a feasibility study at five transplant centers involving 10 bridge-to-transplant patients," said Ventracor CEO Colin Sutton. "The start of implants in the U.S. marks a major step toward the worldwide commercialization of our leading heart assist technology."

Ventracor's heart pump, the VentrAssist left ventricular assist system, is used for patients in cardiac failure. The company is focused on commercializing the VentrAssist and bringing it to global markets in record time. Approval for the study follows submission of and investigational device exemption application in December 2004.