St. Jude Medical Furthers the Company’s Legacy of Heart Valve Excellence With US Launch of the Trifecta Surgical Valve With Glide Technology
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the U.S. launch of the company’s most advanced tissue valve — the Trifecta™ valve with Glide™ Technology (GT) — for the treatment of patients diagnosed with unhealthy, damaged or malfunctioning aortic heart valves. Designed with feedback from a cohort of international physicians, the Trifecta GT tissue valve offers patients the benefit of enhanced valve delivery to ease implantation in challenging anatomies and during minimally invasive surgical approaches.
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The launch comes as St. Jude Medical celebrates its 40th anniversary , affirming the company’s commitment to providing the most advanced technology available to patients. To date, more than 3 million patients globally have received a St. Jude Medical™ valve. As the latest addition to the St. Jude Medical valve portfolio, the Trifecta GT tissue valve continues the company’s legacy of leadership and builds upon the proven best-in-class hemodynamic (circulatory) excellence of the Trifecta™ tissue valve.
“The new tissue valve offers enhancements that will only make the implantation process smoother, providing a solution to patients with even the most challenging of cases,” said Dr. Trey Pluscht, a cardio-thoracic surgeon at Cardio-Thoracic and Vascular Surgical Associates, P.C., of Alabama. “I welcome the opportunity to offer patients the life-changing benefits we’ve come to expect from this family of valves.”
Tissue aortic valve replacement can improve quality of life for patients suffering from valve-related heart failure symptoms and help patients with damaged or diseased native heart valves live longer lives. The original Trifecta valve provided patients a tissue valve that was proven to function in a similar way as their native aortic valve. Now, the Trifecta GT tissue valve has improved upon the original, and provides physicians a tissue valve option that is easier to implant while retaining its optimal hemodynamic performance.
Engineered to reduce wear and deterioration over time, the Trifecta GT stented tissue valve offers improved tissue-to-tissue contact when the leaflets open and close. Additionally, the valve is treated with the St. Jude Medical™ Linx™ AC Treatment, an anticalcification treatment designed to reduce tissue mineralization (hardening). The valve’s fatigue-resistant titanium stent provides a supportive frame within a patient’s heart for added durability.
“Founded as a pioneering manufacturer of implantable bi-leaflet mechanical heart valves, St. Jude Medical has dedicated significant resources to develop best-in-class heart valve replacement options while refining our devices based on physician feedback and clinical outcomes,” said Dr. Mark Carlson, chief medical officer and vice president of global medical affairs at St. Jude Medical. “The Trifecta GT tissue valve is a true testament of our commitment to the cardiac surgery community and the patients they treat by improving the ability to implant the valve when encountering challenging anatomies and during minimally invasive surgical approaches.”
The Trifecta GT tissue valve received FDA approval in April 2016, further expanding the St. Jude Medical valve product portfolio, which includes market-leading mechanical heart valves, aortic and mitral tissue valves, valve repair annuloplasty rings and the Portico™ TAVR valve available currently in Europe. The Trifecta GT tissue valve is CE Mark approved and available in Europe.
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media .
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 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2016. 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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