Edwards Lifesciences has announced further expansion of its structural heart portfolio, after entering into agreement to acquire Jenavalve Technology and exercising an option to acquire Endotronix.
These acquisitions come shortly after the company announced it would acquire Innovalve Bio Medical, an early-stage transcatheter mitral valve replacement (TMVR) company, whilst also signing agreements with Affluent Medical relating to the company’s mitral valve technologies.
JenaValve is the developer of the Trilogy transcatheter aortic valve implantation (TAVI) system, a transfemoral transcatheter aortic valve implantation (TAVI) system which carries a CE mark for the treatment of aortic regurgitation (AR) and aortic stenosis (AS).
The device is seen as meeting an unmet need for the treatment of AR, particularly among patients who are deemed to be at too high risk for surgery. Edwards anticipates US Food and Drug Administration (FDA) approval of the Trilogy system in late 2025.
Results of the ALIGN-AR pivotal trial of Trilogy, which is intended to support the a premarket approval submission to the FDA, were presented at the 2023 TCT meeting (23–26 October, San Francisco, USA) demonstrated a favourable performance in terms of the efficacy of the device, determined by the rate of all-cause mortality at one year, with a rate of 7.8% reported by investigators compared against a 25% prespecified historical control, as well as safety.
Trilogy will join Sapien 3 in the Edwards TAVI portfolio. The balloon-expandable Sapien family of devices are among the most widely used TAVI platforms across the globe for the treatment of AS, with approvals across a range of risk profiles.
Further to the JenaValve transaction, Edwards has exercised its option to acquire Endotronix, the developer of the Cordella pulmonary artery (PA) sensor, an implantable heart failure patient management platform, which received FDA premarket approval last month.
Edwards first invested in the company in 2016, and in a press release said that the acquisition will expand its structural heart portfolio into a “new therapeutic area to address the large unmet needs of patients suffering from heart failure”.
“These acquisitions expand our opportunities to address the unmet needs of aortic regurgitation and heart failure patients around the world,” said Bernard Zovighian, Edwards’ CEO. “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.”
The spate of acquisitions have been spurred by Edwards’ sale of its Critical Care product group to BD in June. At the time the company said that this would fund strategic growth investments in technologies for aortic, mitral, tricuspid and pulmonic patients, as well as new therapeutic areas for interventional heart failure.
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.
