Healthcare Industry News:  neuromodulation 

Devices Interventional Cardiology

 News Release - December 13, 2011

St. Jude Medical Announces First Implant in European Clinical Trial Studying Portico Transcatheter Aortic Heart Valve

Company remains on track for limited European launch in 2012

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced the first implant of its Portico™ transcatheter aortic valve implant (TAVI) in a European clinical trial to support CE Mark approval. The trial will study the safety and effectiveness of the Portico heart valve for patients with severe symptomatic aortic stenosis (narrowing of the aortic heart valve), who are at high risk for conventional open-heart valve replacement therapy.

The trial is a non-randomized study that will take place at five European centers, and will enroll a minimum of 30 patients who will be followed for one year. The primary endpoint is 30-day all-cause mortality, with secondary safety and effectiveness endpoints. Dr. Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K. is the principal investigator for the trial.

“Based on our experience implanting the valve during our feasibility study, and the positive patient outcomes we have seen in those patients, we are looking forward to studying the use of this next-generation technology with additional patients,” said Dr. Manoharan, who implanted the first patient in the trial.

The Portico valve, with leaflets 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, an advancement over current-generation transcatheter valves.

The 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. While the trial will study the 23 mm Portico valve and transfemoral delivery system, both transfemoral (delivered via the femoral artery) and transapical (delivered via a small incision in the apex of the left ventricle) approaches are ultimately expected to be possible with the Portico valve portfolio.

“With the initiation of our European pivotal trial, we continue to make strides toward the commercialization of our Portico transcatheter heart valve,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “We remain on track to begin a limited launch of this product in Europe before the end of 2012.”

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.


Source: St. Jude Medical

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