June 17, 2013 — Valtech Cardio Ltd. announced that two patients diagnosed with severe mitral regurgitation (MR) have been treated successfully with its 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 Professor Ottavio Alfieri, head of the division of cardiac surgery and Professor 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 Maisano.
Colombo commented, "The Cardioband system preserves the option for future percutaneous or surgical valve replacement, which makes it the ideal first-line interventional therapy."
"The Cardioband system provides an excellent alternative for patients who are considered at high risk for surgery," said Alfieri.
The cases were presented by Maisano at the EuroPCR conference 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.
For more information: www.valtechcardio.com