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FDA premarket approval · JenaValve Technology · Cardiology

Trilogy Transcatheter Heart Valve

The first transcatheter valve with a dedicated aortic regurgitation indication.

CompareJenaValve press release
Approved · PMA

Trilogy Transcatheter Heart Valve

JenaValve Technology · Cardiology · First US transcatheter valve for aortic regurgitation

Type
Implant
FDA route
Premarket approval (PMA)
Bottom line for your practice
50s read

Patients with symptomatic, severe aortic regurgitation who are at high or greater surgical risk now have a transcatheter valve with a dedicated U.S. indication. The company plans to launch first at participating clinical study sites, then at new hospitals.

What it is
A transcatheter heart valve built for aortic regurgitation. Three radiopaque locators attach directly to the native aortic leaflets to anchor the valve without relying on calcium, and the open-cell nitinol frame is designed to preserve future coronary access.
Indicated for
Patients with native, symptomatic, severe aortic regurgitation who are judged by a Heart Team to be at high or greater risk for surgical aortic valve replacement.
What changes
The company says conventional TAVR valves rely on annular calcification for anchoring, which is typically absent in aortic regurgitation, while Trilogy anchors with locators on the native leaflets. The supporting ALIGN-AR trial was single-arm, with no comparison group.
Evidence
Single-arm studyALIGN-AR Pivotal TrialThe release says the approval is supported by successful results from the ALIGN-AR Pivotal Trial but gives no numeric results or enrollment figure.No randomized comparison group: the result is judged against historical expectations.
Watch for
The evidence is a single-arm study in high-surgical-risk patients, and the release reports no outcome figures, adverse events, contraindications or warnings.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
Premarket approval (PMA). The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.

Clinical summary

Approved for symptomatic, severe aortic regurgitation in patients a Heart Team judges to be at high or greater risk for surgical valve replacement. Where earlier TAVR valves rely on annular calcium to anchor, Trilogy clips onto the native leaflets, so it can be implanted in non-calcified valves. Approval rests on ALIGN-AR, a single-arm study with no randomized surgical comparator.

From the source 7

JenaValve press release

The JenaValve press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of the Trilogy THV System for the treatment of patients with symptomatic, severe AR who are at high or greater risk for surgical aortic valve replacement (SAVR).

    Backs · Pathway: PMA; indication

  2. This approval makes the Trilogy THV System the first and only transcatheter device in the United States with a dedicated indication for eligible patients.

    Backs · First claim

  3. The Trilogy THV System is the first and only transcatheter heart valve in the United States indicated for native, symptomatic, severe aortic regurgitation in patients who are judged by a Heart Team to be at high or greater risk for surgical aortic valve replacement.

    Backs · Indication with Heart Team

View all 7 lines

  1. The PMA approval is supported by successful results from the ALIGN-AR Pivotal Trial, a prospective, multicenter, single-arm Investigational Device Exemption (IDE) study which assessed the safety and efficacy of the Trilogy THV System in high-surgical-risk patients with symptomatic, severe AR.

    Backs · Single-arm ALIGN-AR trial

  2. which is typically absent in AR patients — the Trilogy System features three proprietary radiopaque locators that attach directly to the native aortic leaflets, enabling secure and stable implantation even in the absence of calcium.

    Backs · Three locators

  3. The system’s large, open-cell nitinol frame is designed to preserve future coronary access.

    Backs · Nitinol frame, coronary access

  4. JenaValve intends to commence launch activity for the Trilogy System immediately with participating clinical study sites, followed by new hospitals across the country.

    Backs · Launch plan

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