SYDNEY, Australia, Dec. 18 /PRNewswire/ -- Key points: points: * Achievement of major milestone toward global commercialisation of the VentrAssist * Strategic marketing plan underway to drive acceptance and develop European sales * Three new centres report first VentrAssit implant
Ventracor today announced the British Standards Institute (BSI) has approved CE Marking for the VentrAssist left ventricular assist device (LVAD).
CE Mark approval allows Ventracor to market and sell the VentrAssist throughout Europe.
Ventracor Chief Executive Officer Peter Crosby said: "We are very excited that we have achieved a major milestone, and the VentrAssist is now commercially available throughout the whole of Europe.
"Regulatory approval is a very important first step towards market acceptance. We will continue our drive to develop strong clinical data published in reputable scientific journals by key opinion leaders, which is essential to build market acceptance that will drive future sales.
"Now we have CE Mark approval for the VentrAssist, we will back that up with outstanding field, clinical and technical support and we look forward to growing our business in Europe," Mr. Crosby said.
"An important part of our strategy is building partnerships with key opinion leaders through the BRACE study, which maintains the momentum with the CE Mark clinical trial," Mr. Crosby said.
Three new centres have enrolled their first VentrAssist patients, taking the total VentrAssist clinical experience to nearly 80 patients at 12 centres worldwide.
In France, the Hospital Cardiologique Louis Pradel in Lyon, and the Institute du Thorax in Nantes, treated patients under the BRACE Clinical Study.
In the US, the University of Minnesota Hospitals and Clinics in Minneapolis treated a patient under the US Feasibility Trial.
About Ventracor
Ventracor is a global medical device company which has developed an implantable blood pump, the VentrAssist left ventricular assist device (LVAD), as therapy to improve the lives of heart failure patients and their families. Ventracor is dedicated to building partnerships with healthcare professionals to make the VentrAssist the standard-of-care worldwide.
Further information, please visit www.ventracor.com or contact: Peter Crosby, Chief Executive Officer or Graeme Fallet Chief Financial Officer Ventracor Limited +61 2 9406 3100 info@ventracor.com.
VentracorCONTACT: Peter Crosby, Chief Executive Officer, or Graeme Fallet, ChiefFinancial Officer, Ventracor Limited, +61-2-9406-3100, info@ventracor.com
Web site: http://www.ventracor.com/
