St. Jude Medical Announces First Transapical Implant of Portico Transcatheter Aortic Heart Valve
New surgical approach represents continued expansion of company's less invasive heart valve program
ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYS: STJ) , a global medical device company, today announced the first patient implant of its 23 mm Portico™ Transcatheter Aortic Heart Valve using the Transapical Delivery System. In transapical valve delivery, a small incision is made between the patient's ribs and the valve is delivered through the apex (or lower tip) of the left ventricle of the heart. The transapical procedure was performed by Dr. Anson Cheung, associate professor of surgery and director of cardiac transplant at St. Paul's Hospital in Vancouver, British Columbia.
Made of bovine pericardial tissue, the Portico transcatheter heart valve is designed to increase physicians' control and placement accuracy during valve deployment. The Portico valve is the first valve that has the ability to be completely resheathed (the process of bringing the valve back into the delivery catheter) and repositioned at the implant site before being released from the delivery system. The resheathing feature also allows the physician to retrieve the valve, if necessary.
"The Portico heart valve offers additional options in terms of resheathing, retrieving or repositioning the valve which in turn facilitates more accurate placement," said Dr. Cheung. "The ability to implant a heart valve via the transapical approach provides an important alternative to treat patients who are considered high risk for conventional open-heart surgery."
Because the Portico heart valve can be implanted without placing the patient on cardiopulmonary bypass, where a machine takes over heart and lung function during surgery, this makes it an appropriate treatment option for patients with severe aortic stenosis. As an alternative to transapical delivery, Portico valves can also be delivered through a catheter inserted in the transfemoral artery, which is located in the leg.
"St. Jude Medical incorporates more than 35 years of heart valve experience into the design of the Portico valve and Transapical Delivery System," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. "The first patient implanted with the transapical delivery approach represents a significant milestone in our ongoing efforts to provide physicians a wide range of options to best treat their patients."
Recently, St. Jude Medical announced the CE Mark approval of its 23 mm Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System. The Portico Transcatheter Aortic Heart Valve, the Transapical Delivery System and the Transfemoral Delivery System are not yet approved for use in the United States.
For additional information about the Portico valve visit SJMPortico.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.
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 December 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 29, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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