egnite, JenaValve Unite to Detect Trends in Aortic Regurgitation Care

egnite Inc. and JenaValve Technology Inc. have formed a strategic partnership to better understand the care paradigm and associated outcomes of aortic regurgitation (AR) patients. The partnership leverages egnite’s database to quantify prevalence and treatment patterns and has conservatively estimated there may be more than 500,000 U.S. patients diagnosed with moderate or severe AR.
 
“By utilizing cutting-edge analytics and JenaValve’s innovative transcatheter therapies, we hope to drive urgent change, provide improved treatment options, and ultimately save lives,” JenaValve Chief Medical Officer Duane Pinto, M.D., said, emphasizing the need for broader access to therapies. “These findings also provide valuable insights for healthcare providers and policymakers, encouraging further attention toward improving outcomes for patients suffering from AR.”
 
A study presented earlier this year at TVT: The Structural Heart Summit examined two-year treatment rates and outcomes for patients with AR using more than 1 million patients from 25 teaching and non-teaching cardiovascular programs throughout the United States from egnite’s database.
 
Despite high two-year mortality rates and guideline indications for treatment, patients with severe AR received low rates of specialist evaluations and treatment with aortic valve replacement, the study concluded. Data also demonstrated that patients diagnosed with moderate or severe AR and severe left ventricular dilation exhibited similar mortality rates, suggesting that some patients may benefit from earlier assessment by the heart team.
 
“This is one of the first artificial intelligence-driven studies providing critical insights into care patterns for patients with moderate or greater AR in the community,” stated Dr. Nicholas S. Amoroso, assistant professor at the Medical University of South Carolina. “The urgency for digital technologies to identify AR patients earlier and novel therapies to improve outcomes for this vulnerable patient population has never been greater.”
 
JenaValve Technology Inc. designs, develops, and commercializes transcatheter heart valve solutions for treating patients suffering from heart valve disease. The company’s Trilogy Heart Valve System is a transcatheter aortic valve replacement (TAVR) system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR) and symptomatic, severe aortic stenosis (ssAS) in high surgical risk patients. The Trilogy System received CE Mark approval in May 2021, providing European physicians with the first TAVR device with true dual-disease treatment capabilities. JenaValve received Breakthrough Device Designation from the U.S. Food and Drug Administration to facilitate the review of ALIGN-AR, a pivotal U.S. trial, as part of its PMA application for the Trilogy Heart Valve System for treating ssAR in high surgical risk patients. If approved, the Trilogy System would become the first and only U.S. TAVR system indicated to treat AR. JenaValve is headquartered in Irvine, Calif., with additional locations in Leeds, U.K.; and Munich, Germany. JenaValve is backed by Bain Capital Life Sciences, Andera Partners (formerly Edmond de Rothschild Investment Partners), Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.

egnite is a digital health company developing cardiovascular solutions. egnite uses AI-driven algorithms and big data to produce business intelligence for healthcare, elevating the role of data in critical decisions. The company partners with hospitals and life sciences organizations to transform care delivery for cardiovascular patients. The company is based in Aliso Viejo, Calif.