Two patients diagnosed with severe mitral regurgitation (MR) have been treated successfully with Valtech Cardio's Transfemoral Cardioband annuloplasty system. The Cardioband device replaces the need for open-heart surgery for MR patients.
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. As well as being implanted under beating conditions 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 optimise the results of the repair. Importantly, the form and clinical function of the Cardioband closely replicates that of the annuloplasty rings that are currently the standard-of-care in surgery.
The first patients were treated at the San Raffaele Hospital, Milan, Italy. Following a short, fully percutaneous procedure, the Transfemoral Cardioband annuloplasty system reduced the degree of the MR from severe to mild. The patients were discharged 48 to 72 hours after the intervention and follow-up after 30 days indicated that they were continuing to do well. The cases are scheduled to be presented at the EuroPCR conference, being held from 21st to 24th May 2013, in Paris, France, plus Transcatheter Valve Therapies (TVT) 2013, to be held from 12th to 15th June 2013, in Vancouver, Canada.
A multi-centre study is currently ongoing in leading European centres to study the safety and efficacy of the Transfemoral Cardioband annuloplasty system in patients with functional MR who are at high-risk for undergoing surgery. To date, seven patients have been implanted with the Cardioband: two via transfemoral access and five surgically, via transatrial access.