October 24, 2013 — Valtech Cardio Ltd., a medical device company that develops solutions for mitral valve repair and replacement, said 11 patients have been treated with the company's transcatheter (transfemoral) Cardioband Annuloplasty System in three European medical centers.
A clinical update on the Cardioband study will be presented at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium in San Francisco on Oct. 30-31.
The Cardioband device enables transcatheter mitral regurgitation (MR) repair, thereby avoiding open-heart surgery and the use of cardiac bypass machine. Another advantage is that the size of the Cardioband is fitted while the heart is beating, which optimizes the results of the repair. The form and clinical function of the Cardioband closely replicates that of the annuloplasty rings that are the standard-of-care in surgery.
The patients were treated as part of an ongoing multi-center study at the Asklepios Klinik St. Georg Heart Center in Hamburg, Bichat-Claude Bernard Hospital in Paris and San Raffaele Hospital in Milan. The objective was to study the safety of Valtech's Transfemoral Cardioband Annuloplasty System in patients suffering from functional MR who were at high risk for open-heart surgery. The study focused on the overall rate of Major Cardiovascular adverse events (MACE) until hospital discharge and at post-operative 30 days.
"The safety profile of the device is impressive,” said Francesco Maisano, chief medical officer, Valtech. “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 favorable with profound reduction of MR in most patients."
All 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 six months follow-up demonstrating a stable improvement from severe MR to mild MR while nine patients were discharged with mild or no MR.
"We have been waiting for a long time for a transcatheter treatment for mitral regurgitation that can reproduce an effective surgical technique,” said Alec Vahanian, principal investigator, Bichat-Claude Bernard Hospital, Paris, who implanted five patients. “The preliminary results we now have with Cardioband suggest that the Cardioband can do it."
"The Cardioband annuloplasty system provides an excellent alternative for patients who are at high risk to undergo surgery,” said Karl-Heinz Kuck, principal investigator, Asklepios Klinik, St. Georg Heart Center, Hamburg. “The procedure is safe and has the potential to become the first-line interventional therapy."
Valtech Cardio plans to expand the study in the next few months by recruiting additional heart centers throughout Europe. Data from the trial will be used to support and obtain the CE mark and other international regulatory approvals. The company expects to complete enrollment in the first half of 2014.
For more information: www.valtechcardio.com