News | January 31, 2011

First 27 mm Transcatheter Aortic Valve Deployed

January 31, 2011 – The first successful transcatheter implantation of a 27 mm transapical aortic valve prosthesis has been completed. The procedure was performed by Hendrik Treede, M.D., at the University Heart Center Hamburg using JenaValve’s transcatheter aortic valve implantation (TAVI) system.

It was part of the company’s ongoing pivotal CE mark trial

"The procedure was very straightforward and uneventful," said Treede. "Our experience with the JenaValve system is that it provides a stable platform for cardiac surgeons to carefully position and release the prosthesis. JenaValve's technology represents a noteworthy clinical and technical achievement allowing us to expand the use of life-enhancing TAVI procedures."

Current CE-certified transapical TAVI products are indicated for annular sizes up to 25 mm. With the availability of a transapical aortic prosthesis for sizes up to 27mm, the market for TAVI patients will be significantly expanded, providing life-saving therapy to patients previously left untreated. According to Helmut J. Straubinger, CEO of JenaValve, more than 30 percent of all patients with symptomatic severe aortic stenosis (SAS) are not referred or are contraindicated from current surgical valve replacement.

The company is in the midst of a multicenter CE-mark pivotal study to evaluate the safety and effectiveness of its transapical TAVI system. The primary endpoint of the trial is the 30-day mortality rate. Secondary endpoints are procedural success, valve performance and safety.

JenaValve expects to enter the European market with its transapical TAVI system in 2011.

Aortic stenosis, the most prevalent heart valve disease in Western countries, is increasing steadily with an aging population. The decision to surgically replace a diseased aortic valve is problematic in elderly patients due to associated high mortality and morbidity risks. In fact, elderly patients with severe aortic disease symptoms are not often considered candidates for surgery.

For more information: www.jenavalve.de

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