ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced that its Trifecta™ biological pericardial aortic valve has demonstrated positive results in a new study published online in The Journal of Thoracic and Cardiovascular Surgery. The Trifecta valve was evaluated in patients who required aortic valve replacement surgery. The results highlight the outstanding hemodynamic performance of the Trifecta valve (the ability to maximize blood flow through the valve), further confirm safety, and describe its ease of use. This study is one of the largest, multi-center, prospective studies ever conducted on a surgical aortic heart valve.
Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta valve between 2007 and 2009 as part of a U.S. Food and Drug Administration (FDA) pre-market approval study. Data from the study was used to secure European CE Mark approval in 2010, FDA approval in 2011 as well as regulatory approval of the Trifecta valve in Japan in 2012.
A three leaflet tissue valve constructed from a polyester and tissue-covered titanium stent, the Trifecta valve serves as a replacement for the aortic valve, which is located between the heart's left ventricle and the aorta (the vessel which carries blood from the heart to the rest of the body). The valve features leaflets made of pericardial tissue that are attached to the exterior of the stent. This design allows the leaflets to open more fully and efficiently, mimicking the hemodynamic performance of a healthy aortic heart valve. It also limits tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact, which helps protect the valve against mechanical wear. A polyester sewing cuff connects the valve to the annulus of the aortic valve. Finally, the valve also features Linx™ AC Technology, an anti-calcification treatment designed to reduce tissue mineralization (hardening), which can lead to valve deterioration over time.
Dr. Joseph E. Bavaria, Roberts-Measey endowed professor and vice-chief of cardiovascular surgery at the University of Pennsylvania, served as lead author of the journal article.
“The Trifecta valve provides an exceptional hemodynamic profile and the strong clinical results support outstanding one-to-two-year performance data. Additionally, the valve has shown minimal leakage,” said Dr. Bavaria. “I have used this valve for more than five years and have found it easy to implant and very reliable, making it an excellent choice for managing patients who require valve replacement.”
Additional Findings:
- Uniformly low gradients (a reduction in pressure exerted on the heart as blood flows through the valve) indicates exceptional valve function across all sizes for a stented tissue heart valve.
- Favorable hemodynamics in the Trifecta valve led to a uniquely low incidence of severe prosthesis-patient mismatch (when the size of the valve’s flow area is too small in relation to the patient’s body size) with 94.8 percent of patients free from this condition at one year.
- Improved blood flow through the Trifecta heart valve leads to a significant decrease in left ventricular (LV) mass (or thickening of the heart muscle) over the course of one year. High LV mass is one of the most important predictors of heart failure, cardiovascular morbidity and mortality.
- An extremely low rate of paravalvular leak (blood leakage around the area where the valve is sewn in place) and minimal valve regurgitation (a backflow of blood from the aorta into the left ventricle) was reported.
- Despite the advanced age of patients and their high risk profile, study results demonstrated a survival rate of 94.5 percent at two years, which compares favorably to comparative technologies.
“The Trifecta valve was designed specifically to address some of the fundamental limitations of previous aortic valves,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “These outstanding study results offer additional evidence of the value these valves can have for patients with aortic heart disease.”
According to a frequently cited article in The Lancet by Nkomo et al., the prevalence of valve diseases in adults in the U.S. ranges somewhere between 4.2 and 5.6 million people based on adjusted numbers from the 2000 population census.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
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