St. Jude Medical, 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.
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.