FDA Approves Tendyne TMVR System for High-Risk Patients with Complex Mitral Valve Disease

Introduction

In a major regulatory milestone, the US Food and Drug Administration (FDA) has approved Tendyne, a transcatheter mitral valve replacement (TMVR) system developed by Abbott, for use in a carefully selected subset of high-risk patients with mitral valve disease. This landmark approval addresses a longstanding therapeutic gap for patients who are unsuitable for surgery and have anatomies unfavorable for transcatheter edge-to-edge repair (TEER).

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Tendyne: A New Option for a Difficult Population

The Tendyne system is now FDA-approved for patients with:

• Moderate-to-severe mitral regurgitation (MR)

• Severe mitral stenosis

• Moderate MR with moderate-or-greater mitral stenosis due to mitral annular calcification (MAC)

Importantly, these patients must be ineligible for surgery and have anatomy not suitable for TEER—a profile that has previously left clinicians with limited options.

The approval is supported by data from the SUMMIT trial, which evaluated outcomes in patients either randomized to Tendyne or to MitraClip-based TEER. The trial cohort notably included patients with extensive MAC, a calcific burden that renders traditional surgical and transcatheter repair approaches highly risky or technically infeasible.

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Why This Matters: The Clinical Challenge of MAC

Mitral annular calcification (MAC) significantly compromises the flexibility and function of the mitral annulus, leading to a complex spectrum of MR, stenosis, or mixed pathology. Patients with MAC are frequently elderly with multiple comorbidities, making them poor surgical candidates. As Dr. Paul Sorajja noted in the Abbott press release, “Many are considered too high risk for open-heart surgery.”

Until now, these patients had limited access to definitive therapy. TEER, while beneficial in many cases, requires favorable anatomy—something MAC often precludes due to leaflet rigidity and calcific extension.

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Guidelines: Bridging the Gap Between Evidence and Practice

• European Guidelines (ESC/EACTS 2021):

  • Primary MR: Surgical repair is the gold standard unless risk is prohibitive (Class I, Level B).

  • TEER: Considered for inoperable patients with suitable anatomy (Class IIb, Level B).

  • TMVR: May be considered in exceptional cases when neither surgery nor TEER is possible (Class IIb, Level C).

• US Guidelines (ACC/AHA 2020):

  • TEER: Reasonable for high/prohibitive risk patients with primary MR (Class IIa, Level B).

  • For secondary MR, TEER also has a Class IIa, Level B recommendation in selected symptomatic patients.

  • TMVR: Until now, it lacked formal guidance due to the absence of FDA approval.

With this new approval, Tendyne may soon be incorporated into future updates of the US guidelines, offering a lifesaving pathway for patients once considered beyond the reach of effective therapy.

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Global Context: Europe Leading the Way

Europe approved Tendyne five years earlier, based on the Tendyne Global Feasibility Study, allowing for real-world experience to accumulate in complex patients. The US approval will now enable similar progress domestically, offering physicians an expanded interventional toolkit.