Healthcare Industry News:  USGI Medical 

Devices Surgery

 News Release - June 25, 2007

Dr. Lee Swanstrom, a Surgeon at The Oregon Clinic, has Performed the First Transgastric NOTES Gall Bladder Surgery in the US

The 'no scar' surgery is one of the first performed worldwide and introduces an entirely new way to operate on the gall bladder

PORTLAND, Ore., June 25 (HSMN NewsFeed) -- Today, The Oregon Clinic announced that Dr. Lee Swanstrom has recently performed the first transgastric endoscopic cholecystectomy in the US at Legacy Good Samaritan Hospital in Portland, Oregon. Since May, Dr Swanstrom and his surgical team have subsequently completed two additional procedures as part of an IRB (Institutional Research Board) approved research study. The procedure involves removing the gall bladder without making traditional incisions on the surface of the skin, which is expected to result in less pain, lower risk of infection and a reduced recovery time as compared to traditional surgery.

Natural Orifice Transluminal Endoscopic Surgery (NOTES), as this procedure has become known, involves passing flexible surgical tools and a camera through the patient's mouth to reach the abdominal cavity by an incision made in the stomach. Once the operation is over, the surgeon draws any removed tissue back through the patient's mouth and closes the hole in the stomach. Dr Swanstrom's team utilized a new surgical platform -- the EndoSurgical Operating System or EOS (USGI Medical, Inc.) to facilitate these procedures.

"The ability to manipulate, cut and sew tissue is especially challenging when working through the GI tract, which is both long and flexible, and is only possible with new technologies such as the USGI instruments," said Dr. Whiteford, Colorectal Surgeon at the Oregon Clinic and one of Dr Swanstrom's NOTES team.

"These initial cholecystectomy procedures are an important first step in the development of methods and devices to enable the widespread adoption of incisionless NOTES surgery," said Dr. Swanstrom, Director for The Oregon Clinic's Division of Gastrointestinal and Minimally Invasive Surgery (GMIS) and Director of Minimally Invasive Surgery at Legacy Health System. "In our first patients, we used two or three small laparoscopic ports to assess the safety of the procedure and to assist in the refinement of the technique. As we continue to gain experience, our protocol allows us to begin to eliminate these external ports."

As a founding member of NOSCAR, (Natural Orifice Surgery Consortium for Assessment and Research: a group formed in 2005 by leading endoscopic surgeons and gastroenterologists to focus on this emerging area, Dr. Swanstrom, has worked closely with USGI and other industry partners to develop the technology required to perform these procedures. The three recent NOTES cholecystectomies are the culmination of four years of laboratory research to refine this pioneering approach.

"I am happy to begin transitioning our research to direct patient care. The success of this surgery will have very positive implications for patients," states Dr. Swanstrom. "We hope it will reduce patient's recovery time due to the less invasive nature of this surgery, reduce their physical discomfort associated with traditional procedures, and leave them with no visible scarring following their surgery. Even with laparoscopic or "keyhole" surgery, patients stay off of work for several days, and have activity restrictions," explains Dr. Swanstrom. "With NOTES they could potentially go back to work the next day."

Much of the discomfort and recovery time after conventional surgery -- and even laparoscopic surgery -- is due to the incisions made in the abdominal wall, particularly the larger incision needed to remove the gallbladder. However, because NOTES surgeons reach the abdominal cavity through the mouth, there is potentially no need for an incision, allowing patients to be up and around rapidly and with no physical limitations. Although an incision is made in the stomach, this is relatively painless, because the stomach has almost no nerve fibers that register pain, unlike skin and muscle. In the future, the NOTES approach may even make it possible for procedures to be carried out under sedation, rather than general anesthetic. Going through the mouth will also eliminate the risk of post-operative wound infections or hernias because the skin is never cut. And while there is a risk of infecting the abdominal cavity with bacteria from the gastrointestinal tract, studies suggest that risk is small.

"This is truly history-in-the-making," states Dr. Lou Libby, Chief Medical Officer at The Oregon Clinic. "The results of this research study and this groundbreaking method will lay the foundation for conducting surgery more efficiently, reducing costs for the patient, provider and hospital."

"Operating through the body's natural orifices offers promise for faster healing times, less scarring and less pain which could lead to reduced hospitalization and quicker recovery," said David W. Rattner, M.D., co-chair of NOSCAR's ASGE/SAGES Joint Committee and Chief of General and Gastrointestinal Surgery, Massachusetts General Hospital, Boston. "These first successful transgastric gall bladder removals signify a major advance in the field and we congratulate Dr. Swanstrom and his team on this achievement. We are delighted to see the potential benefits of NOTES being investigated in an objective manner by one of the world's leaders in minimally invasive procedures in a responsible and ethical manner."

While Dr Swanstrom's three surgeries represent the first NOTES gall bladder surgeries to be done through the mouth in the United States, on March 21st of this year, a doctor at Columbia University in New York performed a similar procedure through a woman's vagina. Other groups have early experience with a variety of other, more minor, procedures. All of Dr. Swanstrom's patients have had no complications and reported a rapid recovery.

Patients interested in the research study and surgery can contact Dr. Lee Swanstrom at the Gastrointestinal and Minimally Invasive Surgery (GMIS) division of The Oregon Clinic.

About The Oregon Clinic

The Oregon Clinic is one of the largest private specialty physician practices in Oregon. An evidence-based, multidisciplinary organization, The Oregon Clinic provides the highest quality care using a team approach to address medical conditions in the areas of cardiology, gastroenterology, neurology, pulmonology, urology, podiatry, otolaryngology, radiation and medical oncology, cardiothoracic surgery, and general and minimally invasive gastrointestinal surgery. The Oregon Clinic is committed to provide the highest quality care, to practice data-driven medicine, to provide leadership for the healthcare community, and to offer respectful, compassionate service. It was founded in 1994 with the merger of several clinical groups in Portland, offering specialty care from Vancouver to Salem, and from Gresham to Astoria. The GMIS clinic is located at 1040 NW 22nd, Suite 560, Portland, OR 97210. Phone: 503-281-0561. Fax: 503-281-0575. Visit the website at

About Legacy Health System

Legacy Health System is an Oregon-based nonprofit, tax-exempt corporation that includes five full-service hospitals and a children's hospital. With more than 8,500 full- and part-time employees, the Legacy system provides an integrated network of healthcare services, including acute and critical care, inpatient and outpatient treatment, community health education and a variety of specialty services.

About USGI Medical, Inc.

USGI Medical Inc, based in San Clemente, California was founded in 2001 to develop technology for Incisionless EndoSurgery. Potential applications for Incisionless EndoSurgery include Obesity, NOTES (Natural Orifice Translumenal Endoscopic Surgery) and GERD (Gastroesophageal Reflux Disease).

Source: The Oregon Clinic

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