Healthcare Industry News:  Incisionless Operating Platform 

Devices Surgery Regulatory

 News Release - March 30, 2010

USGI Medical's Incisionless Operating Platform(TM) (IOP) Receives CE Mark

IOP Tools Allow Physicians to Operate Without External Incisions

SAN CLEMENTE, Calif., March 30, 2010 -- (Healthcare Sales & Marketing Network) -- USGI Medical, Inc. (USGI) announced today that European regulatory authorities have granted the CE Mark to the instruments that make up its Incisionless Operating Platform(TM) (IOP).

The IOP consists of the Transport(TM) Multi-lumen Access Platform, the g-Lix(TM) Helical Endoscopic Tissue Grasper, the g-Prox(R) Grasping/Tissue Approximation Device, and the g-Cath(TM) Tissue Anchor Delivery Catheters with Expandable Tissue Anchors(TM). Each instrument received individual CE Mark certification.

"Gaining CE Mark approval is a significant step forward in our commercialization of the IOP," said USGI Medical President and CEO Eugene Chen. "We look forward to building long term relationships with European physicians, much like those we have developed with leading surgeons, surgical endoscopists and gastroenterologists in the U.S. We plan to leverage the versatility of the IOP and the durability of the IOP Expandable Tissue Anchors in various incisionless procedures, with an initial focus on bariatrics in Europe."

USGI has developed the first durable suturing system for use in Incisionless Surgery. Recent publications confirm that the Expandable Tissue Anchors exceed surgeons' expectations for tissue remodeling, long-term tissue compatibility and durability. The lack of a proven durable endolumenal suturing technology had limited the growth of incisionless surgery.

"I've been using USGI's Expandable Tissue Anchoring system for over three years, both in the lab and clinically. It is a superb technology and by far the most durable available for endoscopic tissue approximation," said Dr. Lee Swanstrom, Professor of Surgery at Oregon Health Sciences University and Director of the Legacy Institute of Surgical Education and Innovation. "In my view, this is an essential tool for advanced endoscopists interested in the future of minimally invasive surgery, answering many of the remaining questions about secure endolumenal wound closure and permanent tissue remodeling."

The instruments that make up the IOP have previously received 510k clearance from the U.S. Food and Drug Administration and have been used in hundreds of incisionless procedures in the U.S.

About Incisionless Surgery

Incisionless Surgery is the next wave in minimally invasive surgery and is rapidly becoming an option demanded by patients and healthcare providers for its potential to minimize pain, shorten hospital stays, lower treatment costs and eliminate visible external scars. Incisionless Surgery, which encompasses Natural Orifice Translumenal Endoscopic Surgery (NOTES), endolumenal and single-port techniques, can be applied to bariatric surgery, cholecystectomy, appendectomy, GERD (Gastroesophageal Reflux Disease), gastrointestinal cancer and urological and gynecological procedures.

About the USGI Incisionless Operating Platform(TM) (IOP)

USGI Medical designed the Incisionless Operating Platform(TM) (IOP) to enable Incisionless Surgery. Combining the flexibility of endoscopy with the therapeutic benefit of laparoscopy, the IOP offers a stable operating platform, access for multiple, robust, flexible surgical tools and durable tissue anchors to approximate and permanently affix tissue -- important requirements for Incisionless Surgery that traditional endoscopes and endoscopic instruments do not provide. The IOP incorporates the TransPort(TM) Operating Platform and instruments for cutting, suturing and grasping tissue.

About USGI

USGI Medical, Inc., is the leader in Incisionless Surgery technology. The Incisionless Operating Platform(TM) has been designed as one essential surgical platform for translumenal, endolumenal and single-incision procedures.

Source: USGI Medical

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