St. Jude Medical Announces First Implant of Portico Transcatheter Heart Valve

June 7, 2011—St. Jude Medical, Inc. (St. Paul, MN) announced the first human implant of its Portico transcatheter aortic heart valve. John Webb, MD, performed the procedure at St. Paul's Hospital in Vancouver, British Columbia.

Gregory Fontana, MD, and Raj Makkar, MD, are the national Principal Investigators in the company's United States transcatheter aortic valve implantation clinical trial, which will be conducted under an investigational  device exemption from the US Food and Drug Administration. The trial will evaluate the device's safety and efficacy for patients who experience severe aortic stenosis and who may be at an elevated risk for surgery. The European clinical trial of the device is expected to start in late 2011.

According to the company, the Portico transcatheter heart valve is designed for patients with severe aortic stenosis who are considered to be at high risk or inoperable for surgical valve replacement therapy. It will be available for delivery via transfemoral and transapical approaches. The Portico valve is composed of bovine pericardial tissue and is engineered to increase control and placement accuracy during valve deployment. The valve can be completely resheathed and retrieved before it is released from the delivery system, allowing repositioning of the valve at the implant site.

“The St. Jude Medical transcatheter valve is a promising new technology that is likely to offer increased functionality for transfemoral and transapical implantation,” commented Dr. Makkar. “We are looking forward to offering an advanced, less-invasive treatment for patients at high risk for surgery.” Dr. Fontana added, “Many of the shortcomings of first-generation devices have been addressed with the next-generation St. Jude Medical Portico transcatheter valve.”