Valve Repair While The Heart Beats

Heart valve repair without open heart surgery is moving closer to EU regulatory approval.

Valtech Cardio Ltd announced that 11 patients have been treated with the company’s transcatheter (transfemoral) Cardioband™ Annuloplasty System in three leading European medical centers.

A clinical update on the Cardioband study is scheduled to be presented at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium in San Francisco on October 30-31 (see details below).

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. 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 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 is to study 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.

Dr. Francesco Maisano, Valtech’s Chief Medical Officer, commented: “The safety profile of the device is impressive. Throughout these eleven procedures, the Cardioband device has demonstrated an excellent safety profile with no MACE to date.” Dr. Maisano added, “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 6 months follow-up demonstrating a stable improvement from severe MR to mild MR; while nine patients were discharged with mild or even no MR.

Prof. Vahanian, Principal Investigator at Bichat-Claude Bernard Hospital, Paris, who implanted five patients noted, “We have been waiting for a long time for a transcatheter treatment for mitral regurgitation that can reproduce an effective surgical technique. The preliminary results we now have with Cardioband suggest that the Cardioband can do it.”

Prof. Karl-Heinz Kuck, Principal Investigator at the Asklepios Klinik St. Georg Heart Center in Hamburg, said: “The Cardioband annuloplasty system provides an excellent alternative for patients who are at high risk to undergo surgery. 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 leading heart centers throughout Europe. Data from the trial will be used to support and obtain the CE Mark and other international regulatory approvals. Enrollment is expected to be completed in the first half of 2014.

The following sessions related to the Cardioband system will be presented during the TCT conference: Wednesday October 30, 2013: Room: Moscone North, Lower Level, Room 135 Session: Selected Translational Topics II. Catheter-Based Mitral Valve Intervention 10:24 a.m. Percutaneous Annuloplasty: The Valtech Cardioband Approach Francesco Maisano Thursday October 31, 2013: Room: Moscone North, Lower Level, Presentation Theater 4 Session: Edited Taped Cases III 10:00 a.m. – 10:30 a.m. Transfemoral Cardioband Mitral Annuloplasty System Francesco Maisano About Valtech Cardio Ltd. Founded in 2005, Valtech Cardio Ltd is a privately held company specializing in the development of devices for mitral valve repair and replacement. The company’s portfolio is based on established mitral valve treatments and includes both surgical and transcatheter-based solutions. The company’s products are designed to enable size adjustment under beating heart conditions for individualization of the repair. Valtech’s first surgical device, the Cardinal adjustable annuloplasty ring, was approved for commercialization in the European Union in 2011. Over 75 patients have been implanted with the Cardinal ring. The Cardioband Annuloplasty System is an investigational device, limited by applicable law to investigational use and not available for sale. For more information, visit the company’s website: http://www.valtechcardio.com or contact: Amir Gross at info@valtechcardio.com, +972-3-533-5959