St. Jude Medical Portico Transcatheter Valve Demonstrates Promising Results in Feasibility Study
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the feasibility study results for the company's Portico™ Transcatheter Aortic Heart Valve, presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
- (1888PressRelease) November 15, 2011 - The results presented today by Dr. Ganesh Manoharan were part of a 10 patient feasibility study conducted at the Royal Victoria Hospital in Belfast, Northern Ireland. The objectives of the study were to determine the technical feasibility, safety and device deployment characteristics of the 23 mm Portico Transcatheter Aortic Heart Valve and transfemoral delivery system.
At 30 days, study results showed no device or procedure-related adverse events or death. Significantly, the results also demonstrated that a majority of patients had trivial or no paravalvular leak after 30 days. In heart valve replacement procedures, paravalvular leak typically results from a small opening around the outside of the valve.
"Based on our experience implanting the valve and the positive patient outcomes we have seen in these 10 patients, the Portico transcatheter valve technology looks very promising," said Dr. Manoharan. "The St. Jude Medical valve is proving to truly be a next-generation technology. Having the ability to resheath and reposition the valve allowed for accurate valve placement, which - combined with the valve's open cell stent design - likely contributed to the impressive results."
The Portico 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) allowing physicians to reposition the valve at the implant site or retrieve the valve, before it is released from the delivery system.
During the feasibility study, the valve was successfully resheathed twice. No patients in the study required implantation of a pacemaker, there were no clinical strokes, no vascular complications and no additional valves were implanted during the same procedure.
The St. Jude Medical Portico 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).
The European clinical trial for the Portico transcatheter aortic valve is expected to start before the end of 2011.
About TCT
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. Presented in partnership with the American College of Cardiology (ACC), TCT 2011 is the world's leading educational meeting specializing in interventional cardiovascular medicine and takes place November 7-11, 2011 in San Francisco. http://www.tctconference.com/.
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.
Forward-Looking Statements
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 July 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.
For more details, please contact:
Sukhmani
Gutenberg Communications
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