FOR IMMEDIATE RELEASE
Valtech Cardio to Present 1-Year Follow-Up Data of 10 patients at 2015 American College of
Cardiology Meeting
Professor Georg Nickenig, leading researcher in feasibility study, will speak on Cardioband surgical
efficacy with transcatheter annuloplasty
SAN DIEGO, CA March 9, 2015 – Valtech Cardio, Ltd., developer of the Cardioband Annuloplasty System, today
announced that it will be showcasing updated results of its multicenter feasibility study, including initial 1-year
follow-up of 10 patients, at the upcoming 2015 American College of Cardiology Meeting (San Diego, CA).
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.
“We have extremely convincing results with the treatment of 10 patients thus far,” commented Georg
Nickenig, M.D., Ph.D., chairman and professor of the department of cardiology, University Hospital Bonn,
Germany. “Cardioband has proven its efficacy by significantly reducing MR in each patient. In addition, its
safety profile is also proven and this is true for centers across the board. Cardioband is a very exciting,
innovative and novel technique.”
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 see 38 patients already included in our multi-center clinical study with 10 patients reaching
1-year follow up showing positive results,” commented Amir Gross, founder and CEO of Valtech Cardio.
“Clinical experience to date demonstrates the Cardioband’s safety and performance. As more physicians
experience the procedure, we have received consistent feedback of a reproducible and straightforward
implantation procedure. We’re confident that as we continue to gain experience, physicians will recognize the
value of Cardioband as a first-line treatment option for FMR.”
Speaker Presentation by Georg Nickenig, M.D., Ph.D., Department of Cardiology, University
Hospital Bonn, Germany – Monday, 16th of March, 9:15AM Room 11A
“Percutaneous Mitral Valve Direct Annuloplasty With a ‘Surgical-Like’ Ring: Results From MultiCenter First-in-Man Feasibility Trial”
Objectives: To evaluate the feasibility, safety, and performance of a transcatheter adjustable mitral
annuloplasty system in patients with 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 January 2015, 35 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 1 year 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