St. Jude Medical has just announced the first successful human implantation of the company’s Portico transcatheter aortic heart valve in a patient with aortic stenosis. The procedure was performed by Dr. John Webb, director of cardiac catheterization and interventional cardiology at St. Paul’s Hospital in Vancouver, British Columbia. We hear that St.Jude is working hard to make sure the device is safe and secure, so things like perivalvular leaks and valve displacements do not happen during or after implantation. Furthermore, the company is looking into ways to develop both transapical and transfemoral deliveries for the valve. And, in addition, the device, when it is finally approved, might feature the company’s proprietary Linx anticalcification technology that might actually prolong the life of the device and/or prevent calcium buildup and things like embolizations.
Check our exclusive images of the device, and here’s more info about it from the announcement:
The valve, which is made of bovine pericardial tissue, is designed to increase physicians’ control and placement accuracy during valve deployment. The Portico transcatheter heart valve can be completely resheathed (the process of bringing the valve back into the delivery catheter) and retrieved before it is released from the delivery system, allowing physicians to reposition the valve at the implant site. No transcatheter valve currently on the market has the ability to be re-sheathed, repositioned, or retrieved.
The St. Jude Medical transcatheter heart valve was designed for the estimated 400,000 patients with severe aortic stenosis who are considered to be high risk or inoperable for conventional open-heart valve replacement therapy. Two delivery methods will be available for the Portico valve, transfemoral (delivered via the femoral artery) and transapical (delivered via a small incision in the apex of the left ventricle).
Commenting on the first implant, Dr. Gregory Fontana, professor and vice chairman, Department of Surgery at the Cedars-Sinai Heart Institute in Los Angeles, Calif., said, “Many of the shortcomings of first generation devices have been addressed with the next generation St. Jude Medical Portico transcatheter valve.”
In February 2010, St. Jude Medical announced that Dr. Fontana, and Dr. Raj Makkar, director of the Interventional Cardiology and Cardiac Catheterization Laboratory at the Cedars-Sinai Heart Institute, will be the principal investigators in the company’s transcatheter aortic valve implantation (TAVI) clinical trial. The study will evaluate the safety and efficacy of the St. Jude Medical transcatheter aortic valve for patients who experience severe aortic stenosis and who may be at an elevated risk for open-heart surgery.