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US: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.
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JenaValve Announces ALIGN-AR Pivotal Data to be Presented During the Late-Breaking Clinical Trial Sessions at TCT 2023

ALIGN-AR Trial Data to be Presented as Late-Breaker at TCT 2023

IRVINE, Calif., September 19, 2023 – JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that data from the ALIGN-AR Pivotal Trial will be presented by Dr. Vinod Thourani (Piedmont Heart Institute, Atlanta, GA) during the Late-Breaking Clinical Trial sessions at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Francisco, CA. The presentation will take place on Tuesday, October 24th, at 12:06 PM Pacific Time.

Prior to the data presentation, at 11:00 AM Pacific Time, a procedure using the CE Mark approved Trilogy THV System will be shown via broadcast from the University of Cologne. Additionally, a symposium focusing on the Trilogy THV System as a solution to address the unmet need in aortic regurgitation (AR) is scheduled for Thursday, October 26th at 2:15 PM Pacific Time.

The ALIGN-AR trial is a landmark prospective, single-arm investigation device exemption (IDE) study designed to assess the safety and efficacy of the Trilogy THV System in high-risk patients with symptomatic, severe AR. Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA). If approved, the Trilogy THV System would become the first and only transcatheter aortic valve replacement (TAVR) system in the U.S. indicated for the treatment of symptomatic, severe AR.

For additional information on the ALIGN-AR Trial or JenaValve, visit the JenaValve team at Booth #215 at TCT.

About JenaValve

JenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative THV solutions for the treatment of patients suffering from heart valve disease. The Company’s Trilogy THV System is a TAVR system designed to treat patients with symptomatic, severe AR and symptomatic, severe aortic stenosis who are at high surgical risk. The Trilogy THV System received CE Mark approval, providing European physicians with the first TAVR device with true dual-disease treatment capabilities.

JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, 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.

US: CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.

Additional information is available at www.jenavalve.com.

Investor Relations Contact:
Marissa Bych
marissa@gilmartinir.com

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The information in this Reimbursement Guide is provided for educational purposes only and is not intended to be coding or billing advice. This coding information is based upon publicly available information and is current as of April 1, 2026 and subject to change without notice. JenaValve Technology, Inc. cannot guarantee that any product or service billed with the codes listed will be covered or, if covered, the listed payment amount will be paid by any payer. It is the responsibility of the provider to select appropriate codes for each patient and to submit appropriate codes, charges, and modifiers for services rendered. Providers should contact insurers to verify correct coding procedures prior to submitting claims related to the use of JenaValve products. In all cases, providers must bill according to the rules, policies and procedures of individual payers. The medical record should document that the product or procedure was medically necessary and furnished or performed as reported. Clinical need, not reimbursement amount, should always drive clinical decision making. If you have any questions about appropriate billing for products or services, please consult your local payer. The information contained in this guide is provided to assist providers in understanding the reimbursement process. It is intended to assist providers in obtaining accurate and appropriate reimbursement for the healthcare services provided. It is not intended to increase or maximize reimbursement by any payer. It is strongly recommended that providers consult with their payer organizations with regard to local reimbursement policies. The information contained herein is provided for information purposes only and represents no statement, promise, or guarantee by JenaValve Technology, Inc. concerning levels of reimbursement, payment, or charge. Similarly, all CPT codes are supplied for information purposes only and represent no statement, promise, or guarantee by JenaValve Technology, Inc. that these codes will be appropriate or that reimbursement will be made. For additional information, please contact us at reimbursement.usa@jenavalve.com.