Unica™

Advancing TR Treatment
with Cross-caval Innovation

Expanding Care
to the 'Still Forgotten' Population

Unica™ introduces a heterotopic solution that simplifies tricuspid valve replacement by targeting the caval system rather than the valve itself. This innovation sidesteps the complexities of tricuspid valve anatomy and physiology. Thus, paving the way for a simple, safe, and effective treatment option available to all TR patients — including those previously considered untreatable.

Leveraging the success of Trillium™, Unica™ is extending the spectrum of care to an even broader patient population by keeping the RA fully accessible and increasing the anatomical fit.

Technical Excellence for Comprehensive Care

Unica™ meets the unique challenges of tricuspid valve therapy by offering a scalable solution for diverse patient anatomies. By securing and sealing at the SVC and IVC, Unica™ delivers care without interfering on the native valve structure, ensuring no limitation in future clinical options.

Migration Resistant

A single device anchored to two
apposing anatomies (SVC & IVC),
provides reliable anchoring and full
migration resistance.

Mechanically Durable

Designed for long-term fatigue
resistance. Durable for decades of
cardiac function.

Flexible Hinge

Designed to allow angulation in
various challenging anatomies

Broad Anatomical Reach

Engineered to fit a wide
spectrum of anatomical sizes

SVC Skirt

The fabric skirt is specifically designed to seal against the compliant SVC

Two valves

Two tri-leaflet biological tissue valves developed to establish unidirectional flow into the RA. Both valves are designed to accommodate future off the shelf ViV (Valve-in-Valve) if ever needed

IVC Skirt

Large flange sealing skirt creates a secure seal that fits a wide range of anatomies, while allowing the necessary hepatic vein flow

Low Profile Delivery System

26 Fr delivery system for venous transfemoral approach

Recruiting Unica™ Clinical Experience

Vast compassionate use experience

The Unica™ demonstrates unique capabilities in treating high-risk patients who were previously found ineligible for other therapies.
The Unica’s large compassionate use experience, shows compelling clinical results.
Compassionate use of the Unica™ device is available in Canada, Europe and The Middle East.

Dr. Neil Fam
ST. Michael’s Hospital, Toronto, Canada

Dr. Marino Labinaz
University of Ottawa Heart Institute, Ottawa, Canada

Dr. Rodrigo Estevez Loureiro
Ospedale Universitario Álvaro Cunqueiro,
Vigo, Spain

Dr. Didier Tchétché
Clinique Pasteur, Toulouse, France

Dr. Omar Abdul-Jawad Altisent
Hospital Clinic de Barcelona, Barcelona, Spain

Dr. Marco De Carlo
Azienda Ospedaliero Universitaria Pisana,
Pisa, Italy

Dr. Augustin Coisne
Pharmacie Centrale Secteur Essais Cliniques
CHRU de Lille, Lille, France

Dr. Stefan Verheye
ZAS Middelheim, Antwerp, Belgium

Dr. Jozef Bartunek
AZORG Hospital Aalst, Aalst, Belgium

Dr. Philipp Lurz
Universitätsmedizin Mainz, Mainz, Germany

Dr. Leor Perl
Rabin Medical Center, Petah Tikva, Israel

Ongoing FIH trial

The Unica™ is currently available at selected geographies through a First-In-Human (FIH) study, and enrollment completion is anticipated by the end of 2026. The results from the First-In-Human (FIH) study combined with the many compassionate use case performed, will serve as the basis for the approval of a global study in the near future.

Unica™ Publications

01/01/2024

UNICA − a novel single-stent, double-valve, heterotopic, cross-caval approach for severe tricuspid insufficiency

We present an 85-year-old female patient in New York Heart Association (NYHA) Functional Class III, with preserved left ventricular ejection fraction, who experienced recurrent valvular heart failure hospitalisations and cardiac decompensation due to severe, torrential tricuspid regurgitation (TR) with a large coaptation defect (grade 5/5, 16 mm gap) (Figure 1A, Moving image 1). She also […]

28/12/2023

First-in-Human Treatment of Severe Tricuspid Regurgitation Using a Novel Cross-Caval Heterotopic Device

A 79-year-old woman, previously surgically treated for mitral and aortic valve replacement, experienced recurrent torrential tricuspid regurgitation after 2 transcatheter edge-to-edge repair procedures. Heart team assessment deemed the patient high risk for redo surgery and excluded transcatheter edge-to-edge repair and orthotopic replacement. The patient was then scheduled for a novel cross-caval device implantation.