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.
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 the heart.
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 Cardinal ring.