Valtech Cardio to present a clinical update on the Cardioband™
feasibility study at the TCT Symposium
OR YEHUDA, Israel, Oct. 24, 2013 /CNW/ - Valtech Cardio Ltd, a medical device company that develops solutions for mitral valve
repair and replacement, announced today that 11 patients have been
treated with the company's transcatheter (transfemoral) Cardioband™
Annuloplasty System in three leading European medical centers.
(Photo: http://photos.prnewswire.com/prnh/20130516/613819 )
A clinical update on the Cardioband study is scheduled to be presented
at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT)
Symposium in San Francisco on October 30-31 (see details below).
The Cardioband device enables transcatheter Mitral Regurgitation (MR)
repair, thereby avoiding open heart surgery and the use of cardiac
bypass machine. Another advantage is that the size of the Cardioband is
fitted while the heart is beating which optimizes the results of the
repair. Importantly, the form and clinical function of the Cardioband
closely replicates that of the annuloplasty rings that are today the
standard-of-care in surgery.
The patients were treated as part of an ongoing multi-center study at
the Asklepios Klinik St. Georg Heart Center in Hamburg, Bichat-Claude
Bernard Hospital in Paris and San Raffaele Hospital in Milan. The
objective is to study the safety of Valtech's Transfemoral Cardioband
Annuloplasty System in patients suffering from functional MR who are at
high risk for open heart surgery. The study focuses on the overall rate
of Major Cardiovascular adverse events (MACE) until hospital discharge
and at post-operative 30 days.
Dr. Francesco Maisano, Valtech's Chief Medical Officer, commented: "The
safety profile of the device is impressive. Throughout these eleven
procedures, the Cardioband device has demonstrated an excellent safety
profile with no MACE to date." Dr. Maisano added, "Cardioband is the
most promising valve repair technology. Early outcomes are extremely
favorable with profound reduction of MR in most patients."
All patients that have been implanted with the Cardioband system have
experienced a reduction in the mitral valve annular size and an
increase in coaptation length. To date, two patients have completed 6
months follow-up demonstrating a stable improvement from severe MR to
mild MR; while nine patients were discharged with mild or even no MR.
Prof. Vahanian, Principal Investigator at Bichat-Claude Bernard
Hospital, Paris, who implanted five patients noted, "We have been
waiting for a long time for a transcatheter treatment for mitral
regurgitation that can reproduce an effective surgical technique. The
preliminary results we now have with Cardioband suggest that the
Cardioband can do it."
Prof. Karl-Heinz Kuck, Principal Investigator at the Asklepios Klinik
St. Georg Heart Center in Hamburg, said: "The Cardioband annuloplasty
system provides an excellent alternative for patients who are at high
risk to undergo surgery. The procedure is safe and has the potential to
become the first-line interventional therapy."
Valtech Cardio plans to expand the study in the next few months by
recruiting additional leading heart centers throughout Europe. Data
from the trial will be used to support and obtain the CE Mark and other
international regulatory approvals. Enrollment is expected to be
completed in the first half of 2014.
The following sessions related to the Cardioband system will be
presented during the TCT conference:
Wednesday October 30, 2013:
Room: Moscone North, Lower Level, Room 135
Session: Selected Translational Topics II. Catheter-Based Mitral Valve
10:24 a.m. Percutaneous Annuloplasty: The Valtech Cardioband Approach
Thursday October 31, 2013:
Room: Moscone North, Lower Level, Presentation Theater 4
Session: Edited Taped Cases III
10:00 a.m. - 10:30 a.m. Transfemoral Cardioband Mitral Annuloplasty
About Valtech Cardio Ltd.
Founded in 2005, Valtech Cardio Ltd is a privately held company
specializing in the development of devices for mitral valve repair and
replacement. The company's portfolio is based on established mitral
valve treatments and includes both surgical and transcatheter-based
solutions. The company's products are designed to enable size
adjustment under beating heart conditions for individualization of the
repair. Valtech's first surgical device, the Cardinal adjustable
annuloplasty ring, was approved for commercialization in the European
Union in 2011. Over 75 patients have been implanted with the Cardinal
The Cardioband Annuloplasty System is an investigational device, limited
by applicable law to investigational use and not available for sale.
SOURCE: Valtech Cardio Ltd.
For further information:
For more information, visit the company's website: http://www.valtechcardio.com or contact: Amir Gross at firstname.lastname@example.org, +972-3-533-5959