Sweden Implants First CardioWest™ Temporary Total Artificial Heart

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease;  Medical Devices / Diagnostics
Article Date: 26 Oct 2008 - 0:00 PDT

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On Oct. 15, Dr. Lars Wiklund, chief of cardiothoracic surgery at Sahlgrenska University Hospital in Gothenburg, Sweden, led his surgical team in performing Sweden's first implant of the CardioWest™ temporary Total Artificial Heart into a 31-year-old male patient. Dr. Ulf Kjellman, head of the 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.

"Discharge drivers substantially reduce the costs associated with in-hospital care, while allowing stable CardioWest patients to shop, travel, visit friends and enjoy a quality of life comparable to people with human hearts," said Dr. Kjellman. (See video)

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% increase in the number of patients benefiting from the CardioWest artificial heart in the 24 months following regulatory approvals.

Sahlgrenska University Hospital is the largest hospital in northern Europe, with more than 2,700 beds and 140 departments. The implant marked the hospital's completion of the CardioWest certification training program, started Aug. 27, 2007. Sahlgrenska University Hospital is the 26th hospital in the world and the 13th hospital in Europe to become a CardioWest certified center.

Sweden joins Germany, France, Austria and Italy as the fifth European country with a hospital certified to implant the CardioWest artificial heart.

Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to human heart transplant for patients dying from end stage biventricular failure.

The CardioWest artificial heart is the first and only FDA, Health Canada and CE Mark approved temporary Total Artificial Heart in the world. There have been more than 750 implants of the CardioWest artificial heart, accounting for more than 140 patient years of life on the device.

The CardioWest