Valtech Cardio Ltd

2013/10/24 15:30


AsiaNet 54747

共同JBN 1269 (2013.10.24)


*Valtech CardioがTCTシンポジウムでCardioband(商標)の実行可能性研究の臨床アップデートを報告へ

僧帽弁修復、置換用のソリューションを開発している医療機器会社のValtech Cardio  (http://www.valtechcardio.com)Ltdは24日、11人の患者が欧州の有力な3医療センターで同社の経カテーテル(経大腿)Cardioband僧帽弁形成システムによる治療を受けたと発表した。




患者は現在行われているマルチセンター研究の一環として、ハンブルクのアスクレピオス・クリニック・ザンクト・ゲオルグ(Asklepios Klinik St. Georg)心臓センター、パリのビシャクロード・ベルナール(Bichat-Claude Bernard)病院、ミラノのサンラファエレ(San Raffaele)病院で治療を受けた。研究の目的は開胸手術のリスクが高い機能性MRにかかっている患者でValtechの経大腿Cardioband僧帽弁形成システムの安全性を調べることである。研究は退院までと手術後30日間の主要心臓血管有害事象(MACE)全体の発生率に集中している。





Valtech Cardioは欧州各地で有力心臓センターを追加募集して今後数カ月で研究を拡大する計画である。試験データはCEマークなど国際的な規制の承認のサポートや取得のために使われる。患者募集は2014年前半に完了する見込みである。



部屋: Moscone North, Lower Level, Room 135


午前10時24分 経皮的僧帽弁形成:ValtechのCardioband手法、フランチェスコ・メサノ


部屋:Moscone North, Lower Level, Presentation Theater 4


午前10時-10時30分 経大腿Cardioband僧帽弁形成システム、フランチェスコ・メサノ

▽Valtech Cardio Ltdについて

2005年に創立されたValtech Cardio Ltdは株式非公開会社で、僧帽弁の修復、置換機器の開発専門会社である。同社のポートフォリオは確立された僧帽弁治療法に基づいており、外科的ソリューションと経カテーテル・ベースのソリューションが含まれている。同社の製品は修復の個人化のため心臓拍動中の条件下でサイズ調整が可能なように設計されている。Valtechの最初の外科機器であるCardinal調整可能僧帽弁形成リングは2011年に欧州連合(EU)で商業化が承認された。これまでに75人の患者がCardinalリングをインプラントされている。


詳しい情報は同社ウェブサイト(http://www.valtechcardio.com)または問い合わせ先(Amir Gross at info@valtechcardio.com、+972-3-533-5959)へ。

ソース:Valtech Cardio Ltd

Eleven Patients Treated with the Cardioband Annuloplasty System for Transcatheter Mitral Repair Show Promising Preliminary Results


OR YEHUDA, Israel, Oct. 24 / PRN=KYODO JBN/ --

   - Valtech Cardio to present a clinical update on the Cardioband(TM)

feasibility study at the TCT Symposium

    Valtech Cardio [http://www.valtechcardio.com ] Ltd, a medical device

company that develops solutions for mitral valve repair and replacement,

announced today that 11 patients have been treated with the company's

transcatheter (transfemoral) Cardioband(TM) Annuloplasty System in three

leading European medical centers.

    (Photo: http://photos.prnewswire.com/prnh/20130516/613819 )

    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


    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,


SOURCE: Valtech Cardio Ltd