For over a decade, EndoGastric Solutions has been providing support for surgeons treating gastroesophageal reflux disease (GERD). It was in 2007 that the manufacturer first received clearance for their EsophyX system.

The third generation of that device — the EsophyX Z — was introduced in the U.S. in 2015 and was recently launched in Europe for use with the TIF 2.0 procedure.

To learn more about the EsophyX Z device and the TIF 2.0 procedure, Surgical Products interviewed Peter Janu, MD, general surgeon with Affinity Health Services in Appleton, Wisconsin.

What has been your experience with the TIF 2.0 procedure?

My background is basically as a general surgeon with a big health system. At one of the hospitals that I go to — the critical access hospital where I’m the de facto general surgeon, vascular surgeon, gastroenterologist, basically jack of all trades —  there were some patients with reflux issues. One of them had somehow come across this procedure and asked me if I was interested in learning about it so that he could be my first patient. This was back in 2010, and reflux wasn’t necessarily a point of interest or a niche or anything like that for me at the time.

Through some contacts that I knew, I ultimately wound up taking the training, and that’s how I started this journey. And after a couple good outcomes, word of mouth spread. If you’re the only one doing a certain procedure in an area, people gravitate towards you pretty quickly.

So now reflux and treatment of reflux has basically become the bulk of my practice — probably in the 60 percent range. I began right when there was transition from the 1.0 to the 2.0 technique, so I’ve gotten to see the iterations of these different devices through the years, from the initial devices to this latest technology. 

(Image credit: EndoGastric Solutions)

What features of the new EsophyX Z device are most notable to you?

With the original device, the procedure was a little bit tactile, its success depending on how well you could see something endoscopically, a little bit of how well you could use your hands and whatnot. This new EsophyX Z device has compacted the bulk of the finesse aspect of the procedure into a very simple dual fastener trigger-fired delivery method.

It used to be that you’d have to kind of individually fire fasteners and have a guidewire needle that would penetrate through the tissue. You’d have to watch the fastener as it’s deployed. Now, it’s just a single squeeze and two fasteners are fired, so you just end up deploying it in different positions. That’s made it very easy to use.

The EsophyX Z is designed in a way that’s very similar to a lot of other instruments that surgeons are used to using, like stapling devices — especially laparoscopic staplers, it’s almost identical to those. And it’s safer because the stylets are now protected and covered.

The other thing is that the shaft of the device was redesigned so that it’s a little less cumbersome and a little bit more streamlined, which makes the introduction a little bit easier than it was with the prior device. It just goes over a standard gastroscope that most people use in their endoscopy practices, so you don’t necessarily have to upgrade to some type of special or fancy infrastructure.

Is it an intuitive process to learn the EsophyX Z model device?

Absolutely. I would liken it to a phone number in the sense that a phone number is a bunch of numbers, but you remember phone numbers as a set of seven, as a unit. The previous procedure had each step as one little unit. Over time, as you get it down, it becomes one unit. But now, for people who are learning, it’s basically this one big unit and you just fire so all seven steps happen at the same time with a simple pull of the trigger. 

Peter Janu, MD
General Surgeon, Affinity Health Services in Appleton, Wisconsin.

What should surgeons be looking for with individual patients to determine patients are a good match for the TIF 2.0 procedure?

Over time what we found was that matching the patient to the appropriate treatment option are the keys to success both from a surgeon standpoint and from a patient standpoint. Because the patient and the surgeon both want to be satisfied with the results. So the idea is to try to avoid failures and pick the patients that are best for the specific procedure.

This is certainly not some kind of panacea that is going to replace medical therapy or traditional laparoscopic surgery by any means. It’s a piece or a tool that might fit some patients better.

It’s designed more for patients who have an earlier disease state, where they don't have horrible ulcers or pronounced inflammation. They’re not going to be a good match if the valve mechanism or the structure anatomically has completely disappeared or disintegrated. It’s basically a tool to reconstruct the proper anatomic geometry rather than reconstructing the entire anatomy.

I still do the traditional laparoscopic surgeries for people that have more severe disease or larger hiatal hernias. The product is designed for patients that don’t have hiatal hernias greater than 2 cm. However, the device recently received clearance to be used on patients whose hiatal hernias larger than 2cm have been laparoscopically repaired in the same anesthesia session. Our group in Wisconsin in conjunction with another group in Indiana, studied this sequence of procedures and we will be presenting the data at the American College of Gastroenterology meeting in October.

There’s such a huge spectrum of symptoms that people experience from reflux. It doesn’t necessarily have to be heartburn — it can be regurgitation symptoms or even coughing, asthma, hoarseness, or sore throat. Those are the regurgitation-related aspects that pills won’t really cover up as well. And this is what can fix those.

When patients have that early disease state, they just want to be better. You don’t want to bring a bazooka — which would be traditional laparoscopic fundoplication — to a knife fight. If the TIF procedure fixes the problem, it’s a very simple, straightforward way for patients to achieve symptom control. The other advantage is that because there’s no anatomical dissection, all other GERD treatment options can be considered if there’s a recurrence of symptoms years later. GERD is a chronic, progressive disease so treatments are designed to control symptoms for as long as possible.

Anything else you’d like to add?

The other facet from a surgical standpoint is that it really adds a nice piece for treatment options for a relatively prevalent disease. In as much as every single patient that walks in your door isn’t necessarily going to be a perfect candidate for this, what it allows is that by offering an alternative option that it brings patients in to at least discuss it. And patients these days, everybody’s looking for options. They don’t want to be told what they do; they want to discuss all these options.

It provides this low risk profile and equivalent efficacy, based on the published stuff and randomized trials. It’s basically as effective as traditional standard-of-care treatments right now, but has less risk and morbidity to it. It provides at least something to discuss with patients. They may still go on to have a traditional surgery or other options, but the unique TIF procedure advantages gives them encouragement to investigate their options. So it becomes a nice little practice tool from a hospital or physician standpoint to expand the practice or the service line.