Israel-based Valtech Cardio has announced 11 patients with severe mitral regurgitation (MR) have been treated using its transfemoral Cardioband annuloplasty system in three European medical centres.
The 11 patients that have been implanted with the Cardioband system have experienced a reduction in the mitral valve annular size and an increase in coaptation length.
To date, two patients have completed a six months follow-up indicated that they were continuing to do well, while nine patients were discharged with mild or even no MR.
Valtech chief medical officer Dr Francesco Maisano said: "Throughout these 11 procedures, the Cardioband device has demonstrated an excellent safety profile with no MACE to date.
"Cardioband is the most promising valve repair technology. Early outcomes are extremely favourable with profound reduction of MR in most patients."
Participating patients were treated as part of an ongoing multi-centre study at the Asklepios Klinik St Georg Heart Center in Hamburg, Bichat-Claude Bernard Hospital in Paris and San Raffaele Hospital in Milan.
The aim of the study is to evaluate the safety of Valtech’s Transfemoral Cardioband Annuloplasty System in patients suffering from functional MR who are at high-risk for open heart surgery.
The study focuses on the overall rate of major cardiovascular adverse events (MACE) until hospital discharge and at post-operative 30 days.
Valtech plans to expand the study in the next few months by recruiting additional heart centers throughout Europe and enrolment is expected to be completed in the first half of 2014.
It is planning to use the results from the trial to support and obtain the CE Mark and other international regulatory approvals.
The Cardioband device is an adjustable annuloplasty band designed for mitral valve repair by a minimally invasive transfemoral procedure that replaces the need for open-heart surgery for MR patients.
The system has the flexibility to adjust the size while the heart is beating and it can be implanted without disturbing the patient’s heartbeat and without any need for a cardiac bypass machine for the treatment.
According to GlobalData estimates, the cardiac valve repairs market in Europe was valued at $38.9m in 2012 and is expected to grow at a CAGR of 3.7% to reach $50m by 2019.
Image: The Transfemoral Cardioband Annuloplasty System. Photo: courtesy of Valtech Cardio Ltd/ PR Newswire.
