ST. PAUL, Minn., Jun 07, 2011 (BUSINESS WIRE) -- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first human implant of its Portico(TM) transcatheter aortic heart valve. The procedure was performed by Dr. John Webb, director of cardiac catheterization and interventional cardiology at St. Paul's Hospital in Vancouver, British Columbia.
"The first human implant of the Portico transcatheter valve is a significant milestone for our transcatheter aortic valve replacement program and was built off of our 30-year legacy in surgical heart valves," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. "The valve is designed to resolve several key limitations associated with the first generation of transcatheter valves, and it demonstrated some of these benefits as it was recaptured and repositioned during its first implant procedure."
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.
"The St. Jude Medical transcatheter valve is a promising new technology that is likely to offer increased functionality for transfemoral and transapical implantation," said Dr. Makkar. "We are looking forward to offering an advanced, less-invasive treatment for patients at high risk for surgery."
The European clinical trial of the St. Jude Medical transcatheter aortic valve is expected to start in late 2011.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
SOURCE: St. Jude Medical, Inc.
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347 (Investor Relations)
Kate Stoltenberg, 651-756-6293 (Media Relations)