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JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System

JenaValve

IRVINE, Calif., October 14th, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the first commercial implants with the Trilogy Heart Valve System in Europe. The procedures, which included treatment of both aortic regurgitation1 (AR) and aortic stenosis1 (AS), took place in multiple centers in Germany, marks the official start of the European commercial launch of Trilogy.

The Trilogy Heart Valve System is the first and only transfemoral TAVR system in the world indicated for the treatment of aortic regurgitation. In addition, The Trilogy system is also CE-Mark approved for aortic stenosis, providing European physicians, for the first time, a device with true dual-disease treatment capabilities.

“We are clearly thrilled about the first commercial implants of the Trilogy Heart Valve System in Europe. Our first commercial implants marked a major milestone accomplishment for JenaValve, but more importantly, there is now a minimally invasive option for patients with severe, symptomatic aortic regurgitation who are not candidates for open-heart surgery and medical management has become ineffective,” said John Kilcoyne JenaValve’s CEO.

“The Trilogy Heart Valve System is a highly innovative treatment option for AR patients, as legacy AS valves offered suboptimal treatment for AR symptoms,” said Prof. Dr. Stephan Baldus, principal investigator for AR in Europe. “JenaValve’s Trilogy System is an effective solution for AR patients that historically had very few options for treatment.”

Prof. Dr. Hendrik Treede, Principal Investigator for AS, also stated, “The Trilogy Heart Valve offers a new option for patients suffering from AR who previously did not have a sufficient treatment option. In addition to the significant advancement to treat patients with AR is, the Trilogy System offers benefits for patients with AS as well.”

About Trilogy

The Trilogy Heart Valve System is a next-generation TAVR device indicated for the treatment of both AR and AS. Its unique design, highlighted by our proprietary locator technology, large open-cells for coronary accessibility, and advanced sealing ring, addresses a significant unmet need in the marketplace for patients suffering from AR. Trilogy is currently the only CE-Mark-approved TAVR system indicated for the treatment of both AR and AS. Beyond approval in the EU, JenaValve is actively enrolling in The ALIGN-AR Clinical Trial to demonstrate the safety and effectiveness of the Trilogy system in the United States. Based on clinical and commercial experience to date, we believe the Trilogy System has the potential to become the standard of care for patients with AR.

About JenaValve

JenaValve Technology, Inc., with locations in Irvine, California, Leeds, U.K. and Munich, Germany, develops and manufactures transcatheter aortic valve implantation (TAVI) systems to treat patients suffering from aortic valve disease.

JenaValve is backed by Bain Capital Life Sciences and Cormorant Asset Management as well as European and Asian investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv (Euronext: GIMB), Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners.

Additional information is available at www.jenavalve.com.

Contact:
Matt Bacso, CFA
matt.bacso@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.