EndoGastric Solutions Launches EsophyX® Z Technology for the TIF® 2.0 Procedure in Europe

Early Access Program starts in Italy with CE-marked device to meet reflux treatment demand

EsophyX® Z Device (Photo: Business Wire)

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REDMOND, Wash.--()--EndoGastric Solutions®, Inc. (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), announced today that the company has launched its international Early Access Program in Europe with a limited release of the EsophyX® Z device used in the transoral incisionless fundoplication (TIF®) 2.0 procedure, expanding availability of this reflux treatment for patients outside the U.S.

“Entering the European market with this innovative technology is an important company milestone as we continue the critical work of improving access to the TIF procedure,” said Skip Baldino, President and CEO, EndoGastric Solutions. “To meet the needs of GERD patients and their health care professionals, this treatment option fills a gap between medications and traditional surgery.”

The EsophyX Fastener Delivery System first received CE Mark – European regulatory approval – on April 24, 2006, and was cleared by the U.S. Food and Drug Administration in 2007. The EsophyX Z model – the third generation EsophyX device – was initially launched in the US in 2015.

As part of its international expansion, EGS will partner with ab medica s.p.a., Italy’s leading company in the production and distribution of medical technologies, for the limited release of the EsophyX Z device in select markets.

“As a cutting-edge distributor of specialized medical and surgical technologies, we are delighted to work with EGS in establishing a strong market presence for the EsophyX Z device through this Early Access Program,” said Filippo Pacinotti, Business Director, ab medica s.p.a. “We are excited to build a foundation for European expansion so that GERD patients here can have access to the TIF 2.0 procedure.”

For more information on the EsophyX Z device, the TIF 2.0 procedure and the international early access program, visit EndoGastricSolutions.com.

About GERD

Gastroesophageal reflux disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 80 million Americans at least once per month. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g., diet, scheduled eating times and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum-dose usage of prescription medications has been linked to a variety of other health complications.

About Transoral Incisionless Fundoplication (TIF®) procedure for reflux

Performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Studies show that for up to three years after the TIF procedure, esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily medications to control symptoms.

More than 18,000 TIF patients have been treated worldwide since the EsophyX® device was launched. In the past ten years, more than 70 peer-reviewed papers from over 50 centers have been published documenting consistent outcomes on over 1,200 unique study patients. For more information, visit www.GERDHelp.com.

About EsophyX® technology

The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The original EsophyX device was cleared by the U.S. Food and Drug Administration in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes – including low profile and larger high-definition models — to treat the underlying anatomical cause of GERD.

Indications

The EsophyX device with SerosaFuse® fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract and is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic GERD.

About EndoGastric Solutions®

Based in Redmond, WA, EndoGastric Solutions, Inc. (http://www.endogastricsolutions.com), is a medical device company focused on developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp, Facebook: GERDHelpcom and Google+: GERDHelp.

About ab medica s.p.a.

ab medica, founded in 1984 through the initiative of Aldo Cerruti, the President of the company, develops and distributes innovative medical products in the fields of robotics, minimally invasive surgery, vascular and heart surgery, cardiac interventions, anaesthesia, radiosurgery and interventional radiology and neuroradiology. The mission of ab medica is to make minimally invasive and non-invasive technologies available to the greatest number of people, enabling more precise interventions, faster and less painful post-operative recovery. Since 2004 ab medica is also a production centre and an R&D scientific park, engaged in the design and realization of a vast range of products and projects.

Contacts

EndoGastric Solutions®, Inc.
Debbie Donovan, 408-621-0216
ddonovan@endogastricsolutions.com
or
Edelman
Sara Dever, 404-460-9659
Sara.Dever@edelman.com

Release Summary

EndoGastric Solutions has launched its international Early Access Program in Europe with a limited release of the EsophyX® Z device used in the TIF 2.0 procedure.

Contacts

EndoGastric Solutions®, Inc.
Debbie Donovan, 408-621-0216
ddonovan@endogastricsolutions.com
or
Edelman
Sara Dever, 404-460-9659
Sara.Dever@edelman.com