The Trilogy System
The valve that makes TAVR
for AR possible
Introduction
A transcatheter solution for aortic regurgitation has been impossible—until now
Other TAVI valves rely on calcification in and around the annulus for anchoring and stability. In patients with aortic regurgitation, there is often no calcification for the TAVI to hold onto, leaving patients with aortic regurgitation no treatment options other than surgery.
The Trilogy Valve
future coronary access
expanding nitinol frame
allows alignment with
native anatomy
and annular conformability
Features
- Large, open cell design enables future coronary access
- Porcine pericardial tissue
- Supra-annular, self-expanding nitinol frame
- Locator technology allows alignment with native anatomy
- Sealing ring provides sufficient anchoring and annular conformability
The Trilogy Delivery System
The delivery system has been engineered specifically for precise and reliable single-action valve deployment within the patient anatomy. It utilizes a catheter deflection mechanism to center the valve above the annulus and integrated rotation and axial positioning for simple and straightforward commissural alignment.
Features
- Single action deployment through a simple advancement mechanism
- Integrated rotation allows for simple and straightforward commissural alignment
- Catheter deflection allows the centering of the Trilogy valve above the annulus
through a simple
advancement mechanism
allows for simple and
straightforward
commissural alignment
allows the centering of
the Trilogy valve above
the annulus
The Trilogy Introducer Sheath
The Trilogy Sheath is an 85cm working length pre-shaped sheath that protects valve and patient anatomy into the ascending aorta, up until valve alignment and positioning.
Features
- The Trilogy sheath facilitates safe vascular access and deliverability of the Trilogy Delivery System
- 85cm working length pre-shaped sheath that provides protection all the way to the ascending aorta, down to the sinotubular junction
vascular access and deliverability
of the Trilogy Delivery System
sheath that provides protection all
the way to the ascending aorta,
down to the sinotubular junction
See the Trilogy System in action
AR is different.
So is our valve.
In 58 patients with aortic regurgitation**
30-day outcomes in
real-world patients
Improvements in NYHA
functional class
At 30 days, patients showed marked improvements in symptoms with 91% of patients in NYHA I/II (vs 74% in NYHA III/IV at baseline).
See how the Trilogy System
is designed to treat severe
AR patients
Learn more about the
causes, symptoms, and
treatment of AR
Get in touch today to learn more about JenaValve and the Trilogy System
*Indications: The JenaValve Trilogy Heart Valve System is indicated for use in patients with native symptomatic, severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are judged by a Heart Team (including a cardiac surgeon), to be at high or greater risk for surgical aortic valve replacement (AVR), with an STS score ≥ 8% at 30 days, or other comorbidities (e.g., porcelain aorta, frailty, chest wall irradiation) that are not captured by the STS risk calculator.
Contraindications: The JenaValve Trilogy Heart Valve System is contraindicated for use in patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication, or who have active bacterial endocarditis or other active infections.
US: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.
**Moderate-severe/severe
†n=49
1Tamm, A. Jenavalve Trilogy TAVR System for the Treatment of Aortic Regurgitation Real-World Results from a Multicenter Cohort. Presented at TCT 2022, Sept. 18, 2022, Boston, MA.