News | November 01, 2012

First Results From Medtronic Engager TAVI Device Demonstrate Positive Outcomes

Data demonstrate high procedural success in late-breaking trials session at European Association for Cardio-Thoracic Surgery Annual Meeting

Engager TAVI Device Medtronic Inc Heart Valve Repair Clinical Study

November 1, 2012 — Medtronic Inc. announced promising data from the Engager European Pivotal Trial for the investigational Medtronic Engager transcatheter aortic valve implantation (TAVI) system. The first results from the multi-center trial support the safety and clinical performance of the valve, which uses a transapical delivery approach to treat patients with severe aortic stenosis who were at high or extreme risk for surgical aortic valve replacement (SAVR).

The positive clinical outcomes, presented during a late-breaking trials session at the European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting, revealed that the Engager system was deployed in the anatomically correct position in all 60 patients. The Engager valve demonstrated strong hemodynamic performance with low transvalvular gradients, and no patients experienced greater than trace paravalvular leak at 30 days as measured by an independent echocardiography core lab. There were no procedures requiring a second valve, and no occurrences of valve embolization, coronary obstruction or device malposition. The 30-day all-cause mortality rate was 9.9 percent, the cardiovascular mortality rate was 8.3 percent, and the incidence of stroke was 1.8 percent.

“Results from the European Pivotal Study indicate that the Engager valve’s design facilitates precise positioning and reduces paravalvular regurgitation, improving two of the most important clinical challenges faced in transcatheter aortic valve implantation. The Engager valve is a valuable new technology and will allow heart teams to meet the varying needs of patients with severe aortic stenosis,” said Hendrik Treede, M.D., Engager Pivotal Trial investigator, University Heart Center Hamburg in Hamburg, Germany.

The Engager transapical valve is designed for minimally?invasive delivery via a catheter inserted in the apex (the lower, pointed end) of the heart. The valve is comprised of bovine tissue leaflets and a self?expanding nitinol frame designed to aid in valve positioning. The valve also is designed to promote annular sealing to minimize paravalvular leak, and to provide anatomical alignment with the coronary arteries.

The Engager valve is not available for use outside this Pivotal Trial and is currently being reviewed for CE mark in Europe.

For more information:

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init