Valtech Cardio Ltd., a medical device company that develops solutions for the correction and replacement of mitral valves, has announced that two patients with the diagnosis of severe mitral regurgitation (MR) were successfully treated with the "transfemoral cardio Band " Annuloplastiesystem.

The cardio-band device makes an open heart surgery in MI patients unnecessarily. The device is implanted, without stopping the heart beat of the patient and the patient is connected to a cardiac bypass machine. Another advantage is that the size of the cardio bands can be adjusted with a beating heart, so the best results are obtained with the correction. It is also important that the form and function of the cardiovascular clinical Annuloplastieringen bands correspond to those which are now used by default in surgical treatments.

The first patients were treated at the San Raffaele Hospital in Milan, Italy, treated. They were from the heart specialist team led by Prof. Ottavio Alfieri , director of the Division of Cardiac Surgery, and Prof. Antonio Colombo , selected, Head of the Department of Cardiology. The procedure was performed by Dr. Francesco Maisano performed.

After a short, completely percutaneous method-Annuloplastiesystem decreased by the "cardio transfemoral band" the degree of difficulty to mild mitral regurgitation. The patients were discharged 48-72 hours after the procedure and check-ups after 30 days showed that it was still good to them.

"The implantation of the Cardio Bands is a simple intervention that could well become a routine procedure," said Dr Maisano.

Professor Colombo said: "Thanks to the cardio-band system is still the option of a future percutaneous or surgical valve replacement, thus it represents an ideal opportunity for the first interventional therapy."

Professor Alfieri added: "The Cardio-band system provides an excellent alternative for patients for whom surgery would be associated [open heart] with a high risk."

The cases of Dr. Francesco Maisano presented in the coming weeks at two conferences: at EuroPCR Conference in Paris , France, and the conference on Transcatheter Valve Therapies (TVT) in Vancouver , Canada.

"Being able to offer the surgical gold standard solution via a transfemoral introduction, is an important milestone," said Amir Gross , Founder and COO of Valtech Cardio. "We are delighted with this success and prepare now preparing to perform the implantations in large heart centers in Germany and France."

A multicenter study is currently underway in Europe's leading centers to evaluate the safety and efficacy of the transfemoral cardio band Annuloplastiesystems in patients with functional mitral regurgitation, for whom surgery would be associated [open heart] with a high risk.

Mitral or mitral insufficiency (MI) is a condition in which the mitral valve does not close properly, which is a considerable flow of blood from the left ventricle into the left atrium during systole. The prevalence of valvular this error increases dramatically with age and reached epidemic proportions in the elderly.

MI is in the United States the most common valvular pathology. About 6.8 million people suffer from this disease and it is diagnosed when other 250,000 patients annually. If MI is left untreated, it can lead to shortness of breath, decreased cardiac output, inability to exercise, congestive heart failure and death.

The control power for the surgical treatment of MI is an artificial ring to remove the mitral valve in order to stabilize the shape and size of the annulus.

The implantation of the Annuloplastierings requires open-heart surgery, where the patient is connected to a cardiac bypass machine and caused a cardiac arrest.

The open-heart surgery leaves many patients with early-or late-stage without a treatment alternative. Only 20% of patients with mitral regurgitation, due to the severity of their disease should be treated, the surgery.

The "Transfemoral Cardio band" Annuloplastiesystem combining an adjustable annuloplasty band, similar to a surgical tape, the implantation of a femoral vein. The connection of the tape with the Mitralklappenkranz is seamless through specially designed anchor. The implant is then adjusted with beating heart under echocardiographic control and until it rests perfectly.

The "cardio transfemoral band" Annuloplastiesystem allows a percutaneous, fully customizable, correction of mitral valve annuloplasty.

So far, the "cardio strip" was implanted in seven patients: two with transfemoral access and a five surgical access through the atrium.