JenaValve Technology
JenaValve Technology, based in Irvine, California, develops the Trilogy Heart Valve System, a medical device for treating severe aortic regurgitation.
Overview
JenaValve Technology develops innovative medical device solutions targeting patients with structural heart disease. Headquartered in Irvine, California, the company also has locations in Munich, Germany, and Leeds, United Kingdom. JenaValve is dedicated to advancing transcatheter aortic valve replacement (TAVR) technologies.
Products
JenaValve Technology offers the Trilogy Heart Valve System, a TAVR solution designed specifically for treating severe aortic regurgitation. The system represents a significant advancement in the management of heart valve diseases, providing a less invasive alternative to traditional surgical methods.
Regulatory Approval
The Trilogy Heart Valve System by JenaValve Technology has received CE mark approval, indicating that it meets the health, safety, and environmental protection standards for products sold within the European Economic Area. This approval is a key milestone in making the system accessible to patients and healthcare providers in Europe.
Clinical Trials
JenaValve Technology participated in the ALIGN-AR Pivotal Trial, a significant clinical trial to evaluate the efficacy and safety of the Trilogy Heart Valve System for patients with severe aortic regurgitation. The results from this trial were published in The Lancet, a leading medical journal, demonstrating the importance and credibility of the study.
Partnerships
JenaValve Technology has established a partnership with the American Society of Echocardiography to enhance the detection and diagnosis of aortic regurgitation. This collaboration aims to leverage echocardiographic expertise to improve patient outcomes and advance the understanding of structural heart disease.