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May12FDA Clears Next-Generation Version of EndoGastric Solutions’ EsophyX Device


EsophyX® Z Fastener Delivery System requires fewer steps for Transoral Incisionless Fundoplication (TIF) procedures

 

REDMOND, Washington—EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EsophyX® Z device.

 

Designed for compatibility with the company’s existing 7.5 mm SerosaFuse® Implantable Fastener cartridges, EsophyX Z allows physicians to reconstruct the gastroesophageal valve and then secure tissue with a trigger-like handle, making the device similar to stapler like devices often utilized in surgery.

 

EsophyX Z will enter a limited release in the U.S. before full commercialization during the summer. Additionally, it is being used in the American Gastroenterological Association’s STAR Registry, which will provide the first real-world data comparing patient outcomes after traditional laparoscopic surgery and TIF with the EsophyX® device.

 

“The EsophyX Z design provides reduced, device operational steps,” said Darren Crow, General Manager, EndoGastric Solutions. “In addition to a reduction in fastener deployment steps, the stylet tips on exiting the device are now shrouded at the tip of the tissue mold.”

 

We gained significant insights from our physicians that aided in the roadmap for this product upgrade, and we are truly grateful for their contributions,” said Skip Baldino, President and CEO of EndoGastric Solutions. “The EsophyX Z clearance represents another proud milestone in EGS’ mission to provide physicians with the tools they need to more effectively treat the root cause of GERD and want a safe, proven, incisionless alternative to surgery.”

 

About EsophyX® technology

 

The original EsophyX device was cleared by the FDA in 2007. EGS launched the third generation EsophyX device, the EsophyX Z, in 2015. The technology has continued to evolve and is a clinically backed tool for physician use in the treatment of GERD. The 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. 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.

 

Indications:

 

The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease 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 gastroesophageal reflux disease.

 

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 another 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 PPI medications to control symptoms.

 

Over 17,000 TIF patients have been treated worldwide since EsophyX® device clearance in 2007. More than 60 peer-review papers from over 50 centers have been published documenting consistent outcomes on over 1,100 unique study patients. For more information, visit www.GERDHelp.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. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach are coated with a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.

 

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 people at least once per month in the U.S. 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 Current Procedural Terminology (CPT®)

 

CPT codes are a listing of descriptive terms and identifying codes for reporting medical services and procedures. The purpose of CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties. CPT® is a registered trademark of the American Medical Association.

 

The Federal Register has posted coding and payment information specific to the new CPT code, allowing patients to more easily receive access to treatment for GERD. Physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty and APC 5331 Complex GI Procedures for TIF procedures as of January 1, 2016.

 

In 2015, four primary GI societies — SAGES, AGA, ACG, ASGE — jointly sponsored an application to the American Medical Association for a new Category I Current Procedural Terminology (CPT®) code. CPT 43210: EGD esophagogastric fundoplasty.

 

About EndoGastric Solutions®

 

Based in Redmond, WA, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company focused on developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of gastroesophageal reflux disease (GERD). EGS has combined the most advanced concepts in gastroenterology and surgery to develop the Transoral Incisionless Fundoplication (TIF®) procedure — a minimally invasive solution that addresses a significant unmet clinical need.

 

Contacts:

 

Debbie Donovan
EndoGastric Solutions, Inc.
Phone: 408-621-0216
EGS eemail: ddonovan[at]endogastricsolutions[dot]com

 

Dawn Fallon
Lazar Partners, LTD
Phone: 646-871-8481 (direct)
dfallon[at]lazarpartners[dot]com