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Approval of new aortic valve allows use in thousands of CABG patients
In April, St. Jude Medical announced that its Trifecta valve was approved by the FDA for the replacement of diseased, damaged or malfunctioning aortic heart valves, addressing the roughly 90,000 patients who undergo CABG to replace their valves in the United States every year.
According to a press release, this new design includes a holder that has been developed to improve visibility and cuff access for suturing, as well as customized sizes that provide physicians with more control in choosing the appropriate replacement valve for each patient’s heart. The valve’s design allows the leaflets to open more fully and efficiently, mimicking the performance of a healthy aortic heart valve and limiting tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact.
 Vibhu R. Kshettry |
 Joseph E. Bavaria |
The Trifecta valve was designed using a polyester and tissue-covered titanium stent to ensure the structural integrity and features leaflets manufactured from pericardial tissue attached to the exterior of the valve stent. Also, to improve durability, the valve includes the St. Jude Medical patented Linx AC Technology, which is an anti-calcification treatment to reduce tissue mineralization, one of the primary causes of valve deterioration.
Besides being the principal investigator in a trial that tested the Trifecta valve, Vibhu R. Kshettry, MD, cardiac surgeon and professor of surgery at the University of Minnesota, has also made a surgical implant training video for the valve and commented to Cardiology Today about the ease of implantation of the device, adding that with the aging population, “use of tissue valves in aortic valve replacement continues to grow. Even patient’s younger than 60 years of age are requesting tissue valve options, and Trifecta will certainly provide a good option.”
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Source: St. Jude Medical |
“The Trifecta valve will continue the ongoing transformation of stented aortic valve replacement,” Joseph E. Bavaria, MD, Roberts-Measy director and vice chief of CV surgery at the University of Pennsylvania in Philadelphia, said in a press release. “While each new technology that extends the portfolio of tissue valve solutions for physicians is critical for enhanced patient care, the Trifecta valve is a significant step forward for cardiac surgeons in the United States. The valve is already becoming known for its exceptional hemodynamic performance, one factor that is particularly important for the treatment of patients with diseased aortic heart valves.”
The Trifecta valve joins the St. Jude Medical valve product portfolio, which includes mechanical heart valves, valve annuloplasty rings and porcine tissue valves.
The valve was first approved by regulatory authorities in Europe and Canada in 2010. – by Brian Ellis
Disclosures: Dr. Kshettry served as a principal investigator for the St. Jude Medical clinical trial for the Trifecta valve. Dr. Bavaria participates on the St. Jude Medical Advisory Board.