News | September 29, 2014

Results of First-In-Human Study of Trinity TAVR Devices Reported

trinity, transcatheter technologies

Trinity Aortic Valve

September 29, 2014 — Transcatheter Technologies GmbH has announced that results of a first-in-human clinical study of its Trinity system have been published ahead of print publication in the July issue of the peer-reviewed medical journal EuroIntervention. The article is titled, “Trinity heart valve prosthesis — a novel repositionable and retrievable transapical transcatheter aortic valve system.”

 

Principal investigator for the study was Christian Hengstenberg, a cardiologist at German Heart Centre, Munich. (The implantation of the device was performed in Caracas, Venezuela.)  Hengstenberg’s patient was a 74-year-old female suffering from severe, symptomatic aortic stenosis. At six-month follow-up, her mean pressure gradient was reduced from 59 mmHG at the start of the study to just 22 mmHG at six months post-implantation. Equally important, there was no paravalvular leak (PVL) and no atrio-ventricular (AV) block, which would have necessitated a pacemaker implantation.
 
“The Trinity aortic valve is designed to be positioned precisely or even repositioned after full implantation, in a safe and simple manner,” said Hengstenberg. “In our study, Trinity’s novel sealing cuff continues to provide outstanding follow-up results without PVL, which is a frequent complication of TAVI. Equally important, the TRINITY aortic valve is designed to reduce the risk of atrio-ventricular (AV) block significantly through supra-annular positioning of the Trinity valve.”
 
“There are several self-expanding TAVI devices claiming repositionability during the implantation process,” said Wolfgang Goetz, M.D., Ph.D., CEO and cardiac surgeon. “The problem with these second-generation TAVI systems is that they cannot be truly repositioned once fully implanted. Trinity, on the other hand, is designed to solve this critically important issue and thereby potentially reduce the undesirable side consequences of PVL.”
 
“With Trinity, once our valve is completely expanded and anchored above the annulus, a cardiologist can fully evaluate the valve’s function to determine whether it needs to be repositioned, retrieved, or kept in the same position,"  added Goetz. "This feature and its supra-annular anchoring are absolutely unique to Trinity, which is why we have positioned Trinity as a Third-Generation TAVI System.”
 
For more information: www.transcatheter-technologies.com

Related Content

Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
News | Cardiac Diagnostics| September 12, 2017
Contracting shingles, a reactivation of the chickenpox virus, increases a person’s risk of stroke and heart attack,...
Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study in Denmark

Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study. Photo credit: Lisbeth Hasager Justesen, Viborg Hospital.

News | Cardiac Diagnostics| September 12, 2017
September 12, 2017 — A new screening program for vascular disease saves one life for every 169 men assessed, accordin
News | Pharmaceuticals| September 12, 2017
September 12, 2017 — Inclisiran lowers low-density lipoprotein (LDL, or “bad”) cholesterol for up to one year in pati
Overlay Init