St. Jude Medical (NYSE:STJ) today marked its 40th birthday with the U.S. launch of its Trifecta GT replacement aortic valve after winning FDA approval last month.
The Little Canada, Minn.-based medical device company was founded in 1976 by medtech legend Dr. Manny Villafaña to make surgical, bi-leaflet replacement valves. Today the company said more than 3 million patients have been implanted with its valves, including the Trifecta GT, which launched in Europe last month after winning CE Mark approval there in February.
The valve’s titanium stent is covered with tissue to improve tissue-to-tissue contact during the leaflets’ motion. St. Jude said the Trifecta GT also features its Linx anti-calcification treatment.
“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,” chief medical officer Dr. Mark Carlson said in prepared remarks. “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 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,” added Dr. Trey Pluscht of Alabama’s Cardio-Thoracic & Vascular Surgical Assoc. “I welcome the opportunity to offer patients the life-changing benefits we’ve come to expect from this family of valves.”
