Sistem Endoskopi SRS Memperoleh Persetujuan FDA atas Pengobatan Gastroesophageal Reflux Disease (GERD)

AsiaNet 49449

OMER, Israel, 24 Mei/ PRNewswire-AsiaNet/ —

Sistem SRS oleh Medigus, menawarkan pengobatan endoluminal untuk salah satu
kondisi kronis yang paling umum

Medigus Ltd [http://www.medigus.com ] (TASE: MDGS) mengumumkan telah
memperoleh persetujuan FDA 510(k) atas pemasaran sistem endoskopi SRS-nya.

(Foto: http://photos.prnewswire.com/prnh/20120524/533495 )

(Logo: http://photos.prnewswire.com/prnh/20120524/533495-logo )

Perangkat SRS ditujukan untuk pengobatan endoluminal invasif minimal GERD.
Endoskopi SRS dimasukkan ke dalam kerongkongan (esofagus) melalui mulut dan
tidak memerlukan sayatan pada rongga perut. Endoskopi ini berisi kamera video
mini, pemandangan ultrasonik, dan perangkat stapel yang memungkinkan operator
melakukan fundoplikasi sebagian (parsial).

Pemasaran perangkat ini diiizinkan oleh Badan Pengawasan Obat dan Makanan
(Food and Drug Administration) Amerika Serikat di jalur 510(k), setelah
berhasil memenuhi kriteria keamanan dan kemanjuran selama uji coba klinis di
banyak pusat (multi-center) di lima negara dan tiga benua. Selain izin FDA,
Medigus telah memiliki tanda CE untuk sistem SRS.

Menurut beberapa sumber, termasuk Pasar Perangkat Endoskopi
Gastrointestinal di AS untuk tahun 2011 & 2012, iData Research, taksiran pasar
potensial perawatan endoskopik GERD di Amerika Serikat adalah 33 miliar dolar
AS, dan jumlah pasien yang menderita GERD di antara penduduk dunia berkisar
antara 5%-17%.

GERD disebabkan oleh asam lambung atau empedu yang seringkali mengalir
kembali ke esofagus. Ini mengiritasi esofagus, sehingga menyebabkan refluks
asam, nyeri ulu hati dan kondisi parah lainnya.

Tentang Medigus Ltd.

Medigus [http://www.medigus.com/Default.aspx ] adalah perusahaan perangkat
medis yang khusus mengembangkan prosedur dan perangkat endoskopi inovatif.
Medigus adalah pengembang pelopor perangkat endoskopi eksklusif unik untuk
pengobatan GERD. Medigus memiliki platform teknologi canggih yang mencakup
unsur-unsur yang diperlukan untuk mengembangkan berbagai prosedur endoskopi.
Platform ini mencakup kamera video CCD dan CMOS terkecil di dunia, stapler
endoskopi, serta jajaran perangkat ultrasonografi (USG) dan endoskopi.

Kontak:

Dr. Yaron Silberman
yaron@medigus.com
Tel: +972-52-6511122

SUMBER: Medigus Ltd


SRS Endoscopic System Receives FDA Clearance for Treatment of Gastroesophageal Reflux Disease (GERD)

OMER, Israel, May 24, 2012 / PRNewswire-AsiaNet/ —

The SRS system by Medigus, offers endoluminal treatment for one of the most common chronic conditions

Medigus Ltd. [http://www.medigus.com ] (TASE: MDGS) announced that it has received FDA 510(k) marketing clearance for its SRS endoscopic system.

(Photo: http://photos.prnewswire.com/prnh/20120524/533495 )

(Logo: http://photos.prnewswire.com/prnh/20120524/533495-logo )

The SRS device is intended for minimally-invasive endoluminal treatment of GERD. The SRS endoscope is inserted into the esophagus through the mouth and does not entail incisions into the abdominal cavity. The endoscope contains a miniature video camera, ultrasonic sights, and a stapling device that enables the operator to perform partial fundoplication.

The device was cleared for marketing by the U.S. Food and Drug Administration in the 510(k) pathway, having successfully met safety and efficacy criteria during a multi-center clinical trial in five countries and three continents. In addition to the FDA clearance, Medigus already possesses a CE mark for the SRS system.

According to several sources, including the US Market for Gastrointestinal Endoscopic Devices 2011 & 2012, iData Research, the estimated potential market for endoscopic treatment of GERD in the United States is 33 billion US dollars, and the number of patients suffering from GERD among the global population ranges between 5%-17%.

GERD is caused by stomach acid or bile frequently flowing back into the esophagus. This irritates the esophagus, causing acid reflux, heartburn and other severe conditions.

About Medigus Ltd.

Medigus [http://www.medigus.com/Default.aspx ] is a medical device company that specializes in developing innovative endoscopic procedures and devices. Medigus is a pioneer developer of a unique proprietary endoscopic device for the treatment of GERD. Medigus has an advanced technology platform that includes the necessary elements for developing a wide range of endoscopic procedures. The platform includes the smallest CCD and CMOS video cameras in the world, endoscopic staplers, ultrasound and endoscopy suites.

Contact:
Dr. Yaron Silberman
yaron@medigus.com
Tel: +972-52-6511122

SOURCE: Medigus Ltd