Abbott Laboratories has received CE mark approval for its Tendyne transcatheter mitral valve implantation (TMVI) system, the first such device approved for use in Europe and the world. The system is intended for patients with leaky mitral valves that are beyond repair and those at high risk for open heart surgery.

The CE mark strengthens Abbott position in the mitral valve space, opening the door to a population of mitral regurgitation (MR) patients not eligible for valve repair with its hugely successful Mitraclip. In 2019, Mitraclip had worldwide sales of $700 million.

Each year, more than 5 million Americans are diagnosed with heart valve disease, and about 25,000 die from the condition. Transcatheter valve procedures utilize catheter technology to access the heart and treat valve disorders without the need for open heart surgery.

The Tendyne system is a minimally invasive treatment for MR, the most common form heart valve disorder in which blood flows backward through a leaky mitral valve. Comprised of a porcine tissue value stretched over a stent-like framework of nitinol memory wire, the self-expanding device comes in multiple sizes and is fully repositionable and retrievable during implantation.

‘A new choice’

Securing European approval to treat high-risk patients “provides the clinical community with a new choice in how we approach correcting a leaking mitral valve,” said Hendrik Treede, professor of cardiac surgery at University Hospital Bonn, Germany.

The CE mark approval was based on a global, prospective, single-arm, multicenter feasibility study to evaluate Tendyne in patients with symptomatic, severe MR and severe mitral annual calcification. The results showed that 98.9% of Tendyne patients were MR-free at discharge, and the results were sustained through one year. A postapproval study of the therapy is underway.

“The launch of the Tendyne device builds upon our history of developing groundbreaking therapies that offer new treatment options for people with serious structural heart conditions who have limited treatment options,” said Michael Dale, senior vice president of Abbott’s structural heart business. “The availability of Tendyne as a treatment option in Europe provides physicians with an additional tool that has been shown to completely correct MR in very ill patients, and it adds to Abbott’s portfolio of life-changing and life-saving treatments.”

Controlled launch

Mary Kokkinen, an Abbott spokesperson, said the company plans a controlled rollout of Tendyne in Europe. “We’re working with hospitals and physicians to ensure high-quality training support, procedural success and patient safety,” she told BioWorld.

Abbott is conducting a pivotal trial in the U.S. to support FDA approval of the Tendyne TMVI system. The 958-patient SUMMIT study, which got underway in 2018, is assessing Tendyne vs. the latest treatment options for people with primary MR. “The study is designed to make the Tendyne therapy available to the widest range of patients who would benefit most from eliminating their MR,” Kokkinen said.

U.S. availability of Tendyne is still a way off, however, According to Clinicaltrials.gov, the study’s estimated primary completion date is June 2022.

Growing field of players in TMVR

Abbott signaled it was stepping up its game in the transcatheter mitral valve replacement (TMVR) space with it purchase of Cephea Valve Technologies in January 2019. The Santa Clara, Calif.-based company is developing a mitral valve replacement that is intended for femoral artery delivery. Abbott acquired Mitraclip in 2009 when it bought Evalve Inc. for $410 million.

Abbott’s structural heart business has been a strong performer, with sales up 17% to $376 million in the fourth quarter of 2019, compared with the same period the prior year. Overall, medical device sales grew nearly 11.5%, led by double-digit growth in diabetes care (33.7%), electrophysiology (10.8%) and heart failure (12.5%), in addition to structural heart. Worldwide sales across all business segments increased 7.1% to $8.3 billion.

Competition in the TMVR space is heated. Edwards has two candidates, the Evoque system, acquired with Cardiaq Valve Technologies in 2015, and the Sapien M3 unit. Boston Scientific Corp. snapped up Millipede Medical Inc. in late 2018, developer of the Iris transcatheter annuloplasty ring, and has predicted the mitral valve repair and replacement market could hit $1 billion by 2021.

Meanwhile, Medtronic plc’s Apollo trial is assessing the Intrepid system in patients with severe, symptomatic MR, as well as an early feasibility study of Intrepid using a minimally invasive transfemoral transseptal approach. Other contenders in the space include Livanova plc and Highlife SAS.

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