Trilogy Demonstrates Superior Technical and Device Success Over Off-Label TAVR in Aortic Regurgitation: Findings from the PURPOSE Study

Aug 26, 2024 22:15 CST Updated 22:15

JenaValve

Developer of Transcatheter Heart Valve Solutions

JenaValvePublish an article aboutTrilogyTreatment of AortaClinical Research on Valve Regurgitation ---《Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study》。

This study is a retrospective study. JenaValve collected clinical data from 18 centers. A total of256 patients with aortic regurgitation, of whom 168 patients (66%) in the control group (treated with commercially available TAVR products), and 88 patients in the experimental group (Accept TrilogyTreatment).Primary endpoint: Technical and device success rate, 1-year all-cause mortality, and the composite of 1-year mortality and heart failure rehospitalization rate.

Specific Research Data

Technical success rate: 98% in the experimental group and 81% in the control group, P<0.001
Device Success Rate: 95% in the experimental group, 73% in the control group, P<0.001
The success rate of the experimental group was higher than that of the control group, mainly due to a significantly reduced incidence of embolism in the experimental group (1.1% in the experimental group vs. 15% in the control group, P<0.001), and the need for valve re-implantation also decreased significantly (The experimental group 1.1%, while the control group 11.%，P<0.004), and moderate residual AR also decreased (Experimental group 1.1%, while control group 10%）；
The permanent pacemaker implantation rates were comparable between the two groups and increased in both (22% in the trial group vs. 24% in the control group; P=0.007).
At the 1-year postoperative follow-up, there were no significant differences in mortality (HR:0.99; P=0.980) and composite endpoint (HR:1.5; P=0.355).

Globally, except for JenaValve'sTrilogy(In addition to JenaValve's J-Valve TF (approved for CE marking) and Jenesis' J-Valve TA (approved by NMPA), all other TAVR products currently on the market...)Is the treatment of aortic stenosis. According to "Chinese Expert Consensus on Transfemoral Aortic Valve Replacement for Pure Aortic Regurgitation 2023》The number of reflux patients in the United States is significantly lower than that of stenosis patients, but in China, there are more reflux patients than stenosis patients. Although the number of reflux patients in the U.S. is lower than that of stenosis patients, the patient population is already very large.

With the aortic valveAs competition in the narrow market becomes increasingly fierce, the reflux market is becoming the key to success in the future TAVR field. Therefore, Edwards made a bold move by acquiringJenaValveTheTrilogyJenaValve's J-Valve, two of the world's best reflux TAVR products.

Trilogy

TrilogyIt is the world's first and currently the only FDA-approved TAVR for the treatment of severe symptomatic aortic regurgitation or aortic stenosis delivered via the femoral artery.TrilogyComposed of a valve and delivery system, the implantation can be completed in three steps: valve positioning, clamping occlusion, and stable release.

TrilogyThe positioning feature enables the valve to be securely anchored on the native leaflets, even in the absence of calcium, while ensuring commissural alignment.

TTrilogy's Valve

TrilogyThe proprietary positioning device not only enables anchoring in non-calcified conditions but also achieves commissural alignment with the native valve leaflets. Additionally, its supra-annular valve design and extra-large outflow mesh design facilitate subsequent long-term hemodynamic performance and PCI interventions. The valve uses porcine pericardial leaflets, with a 24-high-density mesh design at the inflow end to provide annular compliance and sealing effects.

Trilogy Delivery System

The outer diameter of the delivery system is equivalent to 18F, enabling intraoperative bending adjustment and rotational positioning functions.

Trilogy Demonstration

JenaValve

JenaValveFounded in 2006, JenaValve Technology, Inc. is a pioneer in the global TAVR therapy field. Its patented alignment technology enables the artificial valve to align with the natural anatomy and form a natural seal by clipping the leaflets.TrilogyReceived FDA Breakthrough Device Designation in January 2020.