EsophyX(TM) receives FDA clearance
REDMOND, Wash., Sept. 21 /PRNewswire/ -- EndoGastric Solutions announces that the EsophyX(TM) device for performing Transoral Incisionless Fundoplication (TIF(TM)) surgery for treating gastroesophageal reflux disease has received FDA clearance. Patients have already been treated at two leading U.S. medical centers in Portland, Oregon and Columbus, Ohio. Three procedures were completed yesterday under general anesthesia, transoral, incisionless, without any external skin incisions or internal dissections and without laparoscopic assistance. These landmark procedures define the launch of the third generation of surgery -- the era of natural orifice surgery (NOS).
Dr. Scott Melvin, Director of the Center for Minimally Invasive Surgery, and Dr. Dean Mikami, Assistant Professor of Surgery, at Ohio State University (OSU), performed the procedures with the EsophyX(TM) device to treat two patients, and Dr. John Hunter, Mackenzie Professor and Chairman of Surgery, and Dr. Blair Jobe, Associate Professor of the Department of Surgery, at Oregon Health & Science University (OHSU), performed a TIF(TM) procedure using the EsophyX(TM) device in one patient, who was originally scheduled for laparoscopic antireflux surgery.
Thierry Thaure, Chief Executive Officer of EndoGastric Solutions, stated, "We are very excited to launch our second product in the U.S. market." StomaphyX(TM) was launched in the U.S. earlier this year. Both products are already on the market in Europe. Before the availability of EsophyX(TM) and StomaphyX(TM), most patients did not have the opportunity to obtain an anatomical repair, because despite the fact that surgery offers a more durable solution to disease, the invasiveness dissuaded many patients and their referring and treating physicians. "These new incisionless procedures expand the therapeutic window." Laparoscopy, performed with three to six trocar holes in the abdomen offers significant advantage over open surgery, which involves a long incision on the abdomen, but both are still very invasive. Internal incisions to dissect organs and to perform procedures are similar between open surgery and laparoscopy. With EsophyX(TM) and StomaphyX(TM), external and internal incisions have been eliminated.
Dr. John Hunter of Oregon Health & Science University remarked, "I expect EsophyX(TM) to become quite successful because the ELF and TIF(TM) procedures are based on many years of proven surgical concepts and techniques but with access converted to a transoral approach. The EsophyX(TM) procedures lower the hurdle for having surgery and more closely resemble the continuum of care that is familiar to patients. The TIF(TM) procedure fits nicely between pharmaceutical therapy and laparoscopic Nissen fundoplication, and is much more than just a replacement for the Laparoscopic Nissen because of the broader group of patients who can potentially benefit from it."
"There are a staggering number of patients who suffer from reflux with almost 30 million Americans diagnosed with chronic reflux disease who are dependant on medication," states Dr. Scott Melvin of Ohio State University. "EsophyX(TM) offers patients a front line surgical procedure that is incisionless, reversible and repeatable, which is important because it keeps future treatment options open. This is a benefit over laparoscopy, and is particularly important for young patients because reflux is a chronic, progressive disease."
"The EsophyX(TM) device and TIF(TM) procedure have the potential to significantly change the treatment algorithm for reflux disease. We are well on our way to bringing minimally invasive procedures to many patients suffering from this disease, who currently live their lives from pill-to- pill," states Dr. Stefan Kraemer, Founder and Vice President of Procedure Development for EndoGastric Solutions. "Surgical know-how and our European experience have enabled us to fine-tune procedures and training programs. Thanks to our U.S. FDA clearance we are now ready to teach U.S. surgeons and gastroenterologists on the new procedures."
About EndoGastric Solutions
EndoGastric Solutions (EGS) is a pioneer in developing incision-less transoral procedures for the treatment of upper gastrointestinal diseases, including gastroesophageal reflux disease (GERD) and other gastrointestinal disorders. EGS's mission is to utilize current wisdom in the fields of Gastroenterology and Surgery to develop new trans-oral procedures and products to address the largest unmet needs in treating gastrointestinal diseases. EGS designs and manufactures single use instruments for use in incision-less procedures, and focuses on clinically based products for use by gastroenterologists and surgeons.
EGS is a privately held corporation located in Redmond, Washington. Investors include Chicago Growth Partners, DeNovo Ventures, MPM Capital, Advanced Technology Ventures, Foundation Medical Partners, and Oakwood Medical Investors.
For more information about EndoGastric Solutions, Inc., EsophyX(TM) and StomaphyX(TM), please visit:
In the US: http://www.endogastricsolutions.com
In the EU: http://www.egseurope.eu
Other locations throughout the globe: http://www.egsglobal.net
Vice President, Marketing
Chief Financial Officer
U.S. Customer Contact:
Larry K. Fulton
Senior Director of U.S. Sales
EndoGastric Solutions, Inc.
European Customer Contact:
Vice President, Education
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|SOURCE EndoGastric Solutions, Inc.|
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