Valtech's CE Mark-Approved Cardioband® for Transcatheter Mitral Valve Repair to Be Highlighted at the 2015 Transcatheter Cardiovascular Therapeutics Annual Meeting
OR YEHUDA, Israel,
Valtech Cardio, Ltd.,
an innovator in the development of surgical and transcatheter devices for
mitral and tricuspid valve repair and replacement, announces planned activities
at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting
being held October 11-15, 2015, at the Moscone Center in San
Francisco, California. A series of presentations and events will center on the
company's Cardioband® Mitral Reconstruction System,
(Cardioband), a proprietary implantable mitral reconstruction device with a
transfemoral, transseptal delivery system for mitral valve repair, which
recently earned CE Mark approval.
"The recent CE Mark approval of Cardioband represents a significant milestone for this technology, and, ultimately, for patients with heart failure. The designation by the European regulatory body signifies that Cardioband is a safe treatment option for patients with mitral regurgitation, and recent clinical trial data demonstrate its efficacy," said Amir Gross, founder and CEO of Valtech Cardio. "We look forward to demonstrating at the TCT meeting how Cardioband provides a significant addition to the armamentarium of heart surgeons to facilitate mitral valve repair in a first-line setting while preserving the ability to perform future percutaneous or surgical valve repair and/or replacement."
In a multicenter feasibility trial including over 50 patients, Cardioband was shown to significantly reduce annular size, with significant improvement in mitral regurgitation (MR). After 6 months of follow-up, 80% of patients (n = 25) were categorized in NYHA Class I-II, with significant improvement of quality of life as measured with the Minnesota Living With Heart Failure Questionnaire score of 38 to 18 [p<0.05] and had six-minute walk test score of 241 to 326 [p<0.05]). At 12 months' follow-up, 95% of patients (n=17) had sustained MR </= 2+.
"The Valtech Cardioband is a safe and easy to use device that helps to reduce functional mitral regurgitation in patients with heart failure and impaired left ventricular function. Patients can receive early intervention with the Cardioband, meaning a better chance of left ventricular remodeling, and, thus, a higher probability of a successful clinical outcome. Finally, in my experience, I have found the system is easy to learn due to a well-structured training," said Alec Vahanian, M.D., Head of the Department of Cardiology, Bichat Hospital, Paris, France.
Several sessions and lectures at TCT will highlight Valtech's technologies, including Cardioband and CardioValve™:
On Monday, October 12th, Prof. Francesco Maisano will present "Valtech Cardiovalve: Novel Design Features and Clinical Updates" at 4:24 pm during the Transcatheter Mitral Valve Replacement: Devices and Early Experiences session, held from 3:09 pm – 5:10 PM pm, in room 3014-3018 of Moscone West, 3rd floor
On Wednesday, October 14th, during the Transcatheter Mitral Annuloplasty and Ventriculoplasty session, held from 3:48 pm - 5:30 pm, in room 3014-3018 of Moscone West, 3rd Floor, Prof. Karl-Heinz Kuck, MD, will present, "Cardioband: Device Description, Latest Data, and Future Directions" at 4:04 pm followed by Prof. Alec S. Vahanian, who will present "Cardioband: Case in a Box" at 4:14 pm, and Prof. Paul A. Grayburn, MD, who will present "Cardioband Mechanism of Action: Echocardiographic Insights (2-D and 3-D)" at 4:20 pm.
On Thursday, October 15, in room 104 of Moscone South, Prof. Vahanian will present "Up-to-1-Year Follow-up Results of the Transcatheter Annuloplasty Ring Multicentre Trial" during the TCT Award-Winning Oral Abstracts. Dr. Vahanian is scheduled to speak at 1:00 pm
Source: Valtech Cardio, Ltd.
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