Medical devices major – St. Jude Medical made an online release of a new study about its Trifecta pericardial aortic stented tissue valve in The Journal of Thoracic and Cardiovascular Surgery. The device is used as a replacement for the damaged or malfunctioning aortic heart valve, which controls blood flow from the heart through entire body.
The Trifecta valve, which has been constructed using a polyester and tissue-covered titanium stent, is designed to offer improved hemodynamic performance and durability. It offers a number of novel features that improve the implant ability, thereby offering surgeons more flexibility in selecting the appropriate replacement valve for each patient’s heart.
The encouraging results published online re-emphasized the easy-to-implant and safe Trifecta valve’s efficiency in hemodynamic performance. St. Jude conducted this large-scale study as a part of the U.S. Food and Drug Administration (FDA) pre-market approval study. The study was held across 31 centers in the U.S., Europe and Canada and evaluated 1,041 patients between 2007 and 2009. The results helped the company obtain the European CE Mark approval in 2010, FDA clearance in 2011 as well as a nod from the Japanese regulatory body in 2012.
Dr. Bavaria, the lead author of the article, is impressed by the excellent performance data collected over a span of 1-2 years and the minimal risk of valve leakage evident from the strong clinical results. He has used the product for 5 years and is extremely satisfied with the outstanding hemodynamic support provided by the Trifecta.
The Trifecta valve further strengthens St. Jude’s market-leading heart valve franchise. The Trifecta product line led to a 3% increase in sales in St. Jude’s structural heart products business in 2012. The overall sales volume of tissue heart valves grew 20% in 2012, which is encouraging. The company’s key competitors in the heart valve market are Edwards Lifesciences (EW - Free Report) and Medtronic (MDT - Free Report) and Sorin CarboMedics.
St. Jude has a Zacks Rank #3 (Hold). While we remain on the sidelines regarding STJ due to the prevailing softness in the core Cardiac Rhythm Management (“CRM”) business, medical products company like Nuvasive (NUVA - Free Report) , with a Zacks Rank #1 (Strong Buy), warrants a look.