JenaValve is first in receiving CE certification for a true second generation transapical TAVI system
US Media/Investor Contact:
Ronald Trahan, APR, Ronald Trahan Associates, +1-508-359-4005, x108
Results of the pivotal CE-mark trial of the JenaValve transapical TAVI system
are being presented for the first time, on October 3rd, at the 25th Annual Meeting of the
European Association for Cardio-Thoracic Surgery (EACTS) in Lisbon
MUNICH, Germany, Sept. 30, 2011 — JenaValve Technology GmbH, a German
medical device company specializing in the development of transcatheter heart
valve implantation systems, announced today that the Company has received CE
mark approval for its second-generation transapical TAVI system. This system is
used to treat severe aortic valve stenosis in elderly high-risk patients, especially in
patients for whom conventional open-heart surgery is not an option.
"After an exciting and suspenseful development period, we are now able to
commercially release our second generation TAVI system, firstly onto the
European market," said Helmut Straubinger, President and CEO of JenaValve
Technology. "Our transapical TAVI system is designed to offer patients and teams
of cardiac surgeons and cardiologists a significant advantage over currently
available transcatheter aortic valve implantation systems."
The pivotal CE-marking study is a prospective, multicenter, uncontrolled clinical
trial comprising 73 patients with severe symptomatic aortic valve stenosis, which
was held at seven German study sites between October 2010 and July 2011. The
primary endpoint of the trial was the 30-day mortality rate. The secondary
endpoints were the rate of successful implantation, as well as further parameters
for performance and safety of the prosthetic heart valve. The first results of the
study's primary endpoint are being presented at the preeminent EACTS scientific
meeting on October 3, 2011, in Lisbon.
In his podium presentation, cardiac surgeon Dr. Hendrik Treede from the
University Heart Center in Hamburg will present the study data ("Safety and
efficacy outcomes from the multicenter CE-mark study using the JenaValve™
second-generation transcatheter aortic valve implantation [TAVI] system"). The
presentation will take place at 11:45 in Auditorium 1 at the Lisbon Congress
Prof. Dr. Friedrich-Wilhelm Mohr, Medical Director of the Department of Cardiac
Surgery at the University of Leipzig Heart Center, is the Principal Investigator of
the multicenter study. "The study appears to be progressing very promisingly, and
the 30-day trial data support the safety and efficacy of the JenaValve system. Now
patients have access to a new generation system for transapical TAVI treatment.
The JenaValve design allows the cardiac surgeon and cardiologist to achieve
precise positioning and allows repositioning of the heart valve prosthesis with its
unique, patented positioning feelers. It is with these key features that the system
distinguishes itself from its competitors,” said Prof. Mohr.
The transapical TAVI system consists of both the Cathlete delivery system and
The JenaValve heart valve prosthesis. The product is available in three sizes and
covers aortic annulus diameters from 21 to 27mm.
Information on the JenaValve TAVI system
JenaValve has focused its product development on fundamental, patented design
- The JenaValve prosthesis with a low profile
- The unique positioning feelers
- The JenaClip anchoring mechanism
- The ability to reposition the prosthesis
About JenaValve Technology
JenaValve Technology is a medical device company focused on developing transcatheter-delivered aortic
valve systems to treat patients suffering from aortic valve disease. The company develops replacement
aortic valve systems for both transapical and transfemoral approaches (TAVI) to address the needs of
cardiac surgeons and cardiologists. JenaValve is backed by its committed investors: Atlas Venture, Edmond
de Rothschild Investment Partners, NeoMed Management, VI Partners, Sunstone Capital, Gimv. In Europe,
JenaValve Technology GmbH is headquartered in Munich, Germany; its holding company is JenaValve
Technology, Inc., Delaware, USA. Additional information is available at www.jenavalve.de.
JenaValve and JenaClip are trademarks of JenaValve Technology GmbH. JenaValve products are protected
by pending and granted patents as well as by design and utility model rights.
JenaValve Technology GmbH
Printable photos of products and the management team are available on request.