FOR IMMEDIATE RELEASE
Valtech Cardio to Present 6-Month Follow-Up Data at 2015 Joint Interventional Meeting
Professor Karl-Heinz Kuck, leading researcher in feasibility study, will speak on Cardioband surgical
efficacy with transcatheter annuloplasty
ROME, ITALY, February 12, 2015 – Valtech Cardio, Ltd., developer of the Cardioband Annuloplasty System,
today announced that it will be showcasing updated 6-month follow-up results of 20 patients in their
multicenter feasibility study at the upcoming 2015 Joint Interventional Meeting (Rome, Italy). Cardioband, a
transcatheter adjustable mitral annuloplasty system for patients with functional mitral regurgitation (FMR), is
about to receive its CE Mark and has shown considerable promise as a safe, efficacious, and doable
intervention option for FMR patients.
The Cardioband Annuloplasty System combines an annuloplasty implant, similar to the surgical annuloplasty
devices, with a transfemoral venous delivery system. Connection of the implant to the mitral annulus is
sutureless 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.
“The future of FMR treatment lies in the repair-and-replace paradigm,” commented Francesco Maisano, M.D.,
first user of the Cardioband procedure chairman and professor of cardiovascular surgery at The University
Hospital Zurich. “MR repair with Cardioband can be the first-line therapy for severe MR patients. Additionally,
early-stage repair can support ventricular reverse remodeling while keeping the options open for the patient,
supporting the technology’s use at earlier stages.”
The System is a fit for first-line interventional therapy that is reproducible and preserves the option for future
percutaneous or surgical solutions, including clip or neochord secondary or valve-in-ring replacement.
Additionally, it is delivered via a transfemoral delivery system, eliminating the need for open-heart surgery.
The technology has been clinically proven to cause significant annulus anatomy change followed by significant
reduction in MR, as shown in the results of a multi-center feasibility trial presented at this meeting.
“We are thrilled to highlight the positive results from the recent study conducted by Kuck and peers,”
commented Amir Gross, founder and CEO of Valtech Cardio. “Clinical experience to date demonstrates the
Cardioband’s safety and performance. Echo and fluoroscopy imaging supports a reliable and straightforward
implantation procedure in the hands of interventional cardiologists trained by the company. We’re confident
that as more physicians get hands-on experience with the technology, industry will recognize the value of
Cardioband as a first-line treatment option for FMR.”
Speaker Presentation by Karl-Heinz Kuck, M.D., Ph.D., Departement of Cardiology, Asklepios
Klinik St. George, Hamburg, Germany – February 13, 2015
“Transcatheter Annuloplasty With the Cardioband: Surgical Efficacy Delivered With Safety”
Objectives: To evaluate the feasibility, safety, and performance of a transcatheter adjustable mitral
annuloplasty system in patients with functional mitral regurgitation (FMR) in a multicentre study.
Background: Cardioband system enables percutaneous implantation of an adjustable “surgical-like” mitral
annuloplasty ring using a transseptal approach.
Method: Between February 2013 and November 2014, 30 high-risk patients with significant FMR were
enrolled at five sites in Europe. After a Heart Team evaluation, all patients were screened by echocardiography
and cardiac CT to assess feasibility. Echocardiographic data were analysed by an independent core-laboratory.
Conclusion: Transseptal direct mitral annuloplasty with an adjustable “surgical-like” ring is feasible with a
good safety profile. Effective reduction in MR severity is observed in most patients related to a significant
septo-lateral dimension reduction. MR reduction is stable and consistent at 6 months with clinical benefit.
About Valtech Cardio, Ltd.
Valtech Cardio Ltd, founded in 2005, is a privately held company specializing in the development of devices for
mitral 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. Valtech Cardio Ltd. is headquartered in Boston,
Massachusetts, and has R&D facilities in Or Yehuda, Israel.
Press Contact
Jessica Griffith
Pascale Communications, LLC
610.618.0013
Jessica@pascalecommunications.com