Edwards Acquires JenaValve and Endotronix

July 25, 2024—Edwards Lifesciences announced it has entered into an agreement to acquire JenaValve Technology, which is focused on transcatheter treatment of aortic regurgitation (AR). Additionally, Edwards announced it has exercised its option to acquire Endotronix, a developer of heart failure (HF) management solutions.

Edwards noted that JenaValve presented positive results of the United States ALIGN-AR pivotal trial of its Trilogy transcatheter heart valve (THV) system last year.

Vinod Thourani, MD, from the Piedmont Heart Institute in Atlanta, Georgia, delivered the ALIGN-AR data during a late-breaking clinical trial session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California. In March 2024, the company announced the study findings were published by Torsten P. Vahl, MD, et al in The Lancet (2024; 403:1451-1459).

Edwards anticipates FDA approval of the JenaValve Trilogy THV system in late 2025.

The company stated that the acquisition of Endotronix, which builds on an investment made in 2016, will expand Edwards’ structural heart portfolio into a new therapeutic area to address the needs of patients with HF.

Edwards stated that in June Endotronix announced FDA approval for the implantable Cordella implantable pulmonary artery pressure sensor allowing early, targeted therapeutic intervention. A national coverage determination from the Centers for Medicare & Medicaid Services is expected in early 2025.

The aggregate upfront purchase price for these strategic investments is approximately $1.2 billion. The acquisitions are subject to the satisfaction of certain closing conditions, including the receipt of required antitrust and foreign investment approvals, advised the company.

“These acquisitions expand our opportunities to address the unmet needs of aortic regurgitation and heart failure patients around the world,” commented Edwards CEO Bernard Zovighian in the press release. “We are pleased to enter these structural heart therapeutic areas with innovation, world-class science and clinical evidence to provide access to life-saving technologies for patients around the world.”