HTWR Heartware International, Inc. (MM)

OR YEHUDA, Israel, Oct. 9, 2015 /PRNewswire/ -- 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 12^th, 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, 3^rd 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

Cardioband Mitral Reconstruction System

The Cardioband System combines a reconstruction implant, similar to the surgical annuloplasty devices, with a transfemoral, transseptal delivery system. The sutureless connection of the implant to the mitral annulus is achieved using specially designed anchors. Reshaping of the mitral annulus to eliminate Mitral Regurgitation (MR) is done under physiological conditions and echocardiographic guidance for optimal results. Cardioband received CE Mark approval after clinical trial results demonstrated the device is a safe and efficacious intervention option for patients with functional mitral regurgitation (FMR).

About Valtech Cardio, Ltd.

Valtech Cardio, Ltd., founded in 2005, is a privately held company specializing in the development of devices for mitral and tricuspid valve repair and replacement. Valtech Cardio has full in-house development, manufacturing, and clinical research capabilities, and over 130 patents and patent applications. The company, comprised of multidisciplinary development teams, works in close collaboration with world-renowned heart specialists to provide the best possible therapy for mitral patients. Funded in part from investments made by HeartWare International, Inc. (Nasdaq: HTWR) and other private investors, Valtech Cardio, Ltd., is headquartered in Or Yehuda, Israel.  For more information, visit the company's website:  www.valtechcardio.com.

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SOURCE Valtech Cardio, Ltd.