OR YEHUDA, Israel, May 16, 2013 /CNW/ - Valtech Cardio Ltd., a medical
device company that develops solutions for mitral valve repair and
replacement, announced today that two patients diagnosed with severe
mitral regurgitation (MR) have been treated successfully with the
Transfemoral Cardioband™ Annuloplasty System.
(Photo: http://photos.prnewswire.com/prnh/20130516/613819 )
The Cardioband device replaces the need for open-heart surgery for MR
patients. The device is implanted without stopping the patient's heart
from beating and without putting the patient on a cardiac bypass
machine. Another advantage is that the size of the Cardioband can be
adjusted while the heart is beating to optimize 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 first patients were treated at the San Raffaele Hospital, Milan,
Italy. They were selected by the heart team led by Prof. Ottavio
Alfieri, Head of the Division of Cardiac Surgery and Prof. Antonio
Colombo, Head of the Division of Cardiology. The procedure was
performed by Dr. Francesco Maisano.
Following a short, fully percutaneous procedure, the Transfemoral
Cardioband Annuloplasty System reduced the degree of the mitral
regurgitation from severe to mild. The patients were discharged 48-72
hours after the intervention and follow-up after 30 days indicated that
they were continuing to do well.
"Implanting the Cardioband is a straightforward intervention that can
become a routine procedure," said Dr. Maisano.
Prof. Colombo commented: "The Cardioband system preserves the option for
future percutaneous or surgical valve replacement, which makes it the
ideal first-line interventional therapy."
Prof. Alfieri added: "The Cardioband system provides an excellent
alternative for patients who are considered at high risk for surgery."
The cases will be presented by Dr. Francesco Maisano at two conferences
in the next few weeks: the EuroPCR conference, in Paris, France and the
Transcatheter Valve Therapies (TVT) in Vancouver, Canada.
"Being able to deliver the surgical gold standard solution, via a
transfemoral approach is a major milestone," stated Amir Gross, Founder
and Chief Operating Officer of Valtech Cardio. "We are very pleased to
see these successful outcomes and are now preparing to undertake
implantations at major heart centers in Germany and France."
A multi-center study is currently ongoing in leading European centers to
study the safety and efficacy of the Transfemoral Cardioband
Annuloplasty System in patients suffering from functional mitral
regurgitation who are at high risk to undergo surgery.
About Mitral Regurgitation
Mitral valve regurgitation (MR) is a condition in which the mitral valve
leaflets fail to close properly, allowing significant backflow of blood
from the left ventricle into the left atrium during systole. Valve
disease prevalence rises dramatically with age, reaching epidemic
levels in the elderly.
MR is the most common valve pathology in the US. Over 6.8 million people
suffer from the disease and each year 250,000 patients are diagnosed
with MR. If untreated, MR can cause shortness of breath, decreased
cardiac output, intolerance to physical exercise, congestive heart
failure and death.
The standard-of-care in surgically treating MR involves placing an
artificial ring around the mitral valve to stabilize the shape and size
of the annulus.
Implanting the annuloplasty ring requires open heart surgery, which
involves putting the patient on a cardiac bypass machine and stopping
Open heart surgery leaves many early and late-stage patients without a
treatment alternative. Only 20% of the patients with mitral
regurgitation that should be treated because of the severity of their
disease undergo surgery.
About the Cardioband Annuloplasty System
The Transfermoral Cardioband Annuloplasty System combines an adjustable
annuloplasty band, similar to the surgical band, with a transfemoral
venous delivery system. Connection of the band to the mitral annulus is
sutureless, using specially designed anchors. The implant is then
adjusted, under beating heart conditions and echocardiographic guidance
for optimal results.
The Transfermoral Cardioband Annuloplasty System enables percutaneous,
fully adjustable, annuloplasty repair of mitral regurgitation.
To date, seven patients have been implanted with the Cardioband: two via
transfemoral access and five surgically, via transatrial access.
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 to date with the
SOURCE: Valtech Cardio Ltd.
For further information:
visit the company's web site: http://www.valtechcardio.com or contact: Amir Gross at email@example.com, +972-3-533-5959