Our Vast Clinical Experience

Our innovation stands on a solid foundation of extensive
clinical experience, including our First-in-Human (FIH) clinical
trial in Europe, numerous compassionate use procedures,
and the ongoing Early Feasibility Study (EFS) in the US.

OngoingTrillium™ Early Feasibility Study (EFS)

Prospective, single arm, multi-center, Early Feasibility Study (EFS) to assess the safety and performance of Trillium™
in the treatment of severe or greater tricuspid regurgitation (TR).

Inclusion Criteria:

Patient has clinically significant TR graded as severe or greater
Peak central venous pressure of ≥ 15mmHg
Patient has NYHA functional classification of III or IV
Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic

Seattle, WA, USA

Thousand Oaks, CA, USA

Rochester, MN, USA

Detroit, MI, USA

Cincinnati, OH, USA

Nashville, TN, USA‏‎

Wynnewood, PA, USA

New York, NY, USA

Stony Brook, NY, USA

Mainz, Germany

Leipzig, Germany

Berlin, Germany

Exclusion Criteria:

Patients will be excluded from participation if ANY of the
following criteria apply:

Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC
Non-suitable anatomy according to CT scan
Systolic Pulmonary Artery Pressure > 65mmHg
Moderate or more mitral valve stenosis
Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation
Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis
Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher)
Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3) within 14 days of the index procedure
In the opinion of the Investigator or the study eligibility committee, the patient’s life expectancy < 12 months

Completed enrollmentTrillium™ First-in-Human (FIH) Study

Innoventric has completed the Trillium™ First-in-Human (FIH) study, a prospective, single-arm, multi-center trial designed to assess the safety and performance of the Trillium™ device. This study involved twenty patients across nine investigational sites. We have followed the enrolled patients at multiple intervals: initially at baseline, then during the procedure, at discharge, and subsequently at 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years post-procedure. Our team is currently finalizing the collection of this extensive data and analyzing it. We anticipate publishing results soon to share the significant advances and insight gained.
Lead PI: Dr. Philipp Lurz

Dr. Jozef Bartunek, Dr. Marc Vanderheyden
OLVZ, Aalst, Belgium

Dr. Stefan Verheye
ZNA, Antwerp, Belgium

Dr. Volker Rudolph
Heart & Diabetes Center NRW, Bad Oyenhausen, Germany

Dr. Philipp Lurz
Leipzig Heart Center, Leipzig, Germany

Dr. Mohammad Sherif
Herzzentrum der Charité (DHZC), Berlin, Germany

Dr. Rodrigo Estevez-Loureiro
Hospital Alvaro Cunqueiro, Hospital Universitario de Vigo, Spain

Dr. Ignacio Cruz Gonzales
Hospital Universitario de Salamanca, Spain

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

Dr. Ran Kornowski
Rabin Medical Center, Petah Tiqva, Israel

Europe

Saving Lives While Gaining Clinical Expertise

Our clinical experience extends beyond clinical trials, with compassionate procedures demonstrating our ability to provide quality care even to patients currently deemed untreatable.

With many successful procedures in Belgium, Spain, Germany, Georgia, and Canada, we have improved patients’ lives while showcasing the capabilities of our entire portfolio: Trillium™, Koala™, and Unica™.