October 23, 2008 - SynCardia announced that on Oct. 15, Dr. Lars Wiklund, chief of cardiothoracic surgery at Sahlgrenska University Hospital in Gothenburg, Sweden, led a surgical team in implanting the CardioWest temporary total artificial heart into a 31-year-old male patient, making it the first Swedish implant of the device.
Dr. Ulf Kjellman, head of the hospital’s ventricular assist device (VAD) program, performed the implant.
“If it weren’t for the CardioWest artificial heart, this patient would have died,” said Dr. Kjellman. “Both sides of his heart were failing. He needed a heart transplant to survive, but no donor heart was available. His only option was for us to implant the CardioWest artificial heart as a bridge-to-transplant. The artificial heart will make him a stronger and healthier transplant candidate while he waits for a matching donor heart.”
In some countries in Europe, artificial heart patients can wait up to two years for a matching donor heart. Since July 16, 2006, stable CardioWest patients in Europe have been able to recover at home thanks to the CE-approved portable driver.
During Q4 2008, SynCardia will apply to the FDA to conduct an IDE clinical study of the Companion Driver System in the U.S. and will also apply for CE approval in Europe. The Companion Driver is designed for use in both the hospital and at home. SynCardia projects a 400 percent increase in the number of patients benefiting from the CardioWest artificial heart in the 24 months following regulatory approvals.
Sweden joins Germany, France, Austria and Italy as the fifth European country with a hospital certified to implant the CardioWest artificial heart.
For more information: www.syncardia.com