Medical Device Daily

Medical device companies looking for case study examples of how devices can penetrate the drug market, and at the same time save lives, might well consider the progress of Barrx Medical (Sunnyvale, California).

Barrx is the developer of the Halo³⁶⁰ System offering a treatment of Barrett's esophagus, a preemptive approach targeting a condition identified as a precursor to esoph-ageal cancer (adenocarcinoma). And too often Barrett's is poorly served - sometimes fatally so – by drug regimens.

Barrett's begins as gastrointestinal reflux disease (GERD) – that is, heartburn – a nagging problem that individuals tend to treat primarily with over-the-counter medications such as the purple pill and other proton pump medications.

Over an extended period of time, however, GERD segues into a breakdown of esophageal tissues that is a precursor to cancer. And when Barrett's is not controlled, it can then become a cancer that has a discouraging 90% fatality rate, and the interventions are highly invasive.

Targeting the treatment of Barrett's, the Halo³⁶⁰ System provides increasing evidence of successful treatment of this condition, and Barrx recently hailed publication of a new study, “Thin Layer Ablation of Human Esophageal Epithelium Using a Bipolar Radiofrequency Balloon Device,“ as demonstrating the safety and efficacy of the system. Specifically, the study, appearing in the January issue of Surgical Endoscopy, the journal of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES; Chicago) demonstrated the ability of Halo to kill the precancerous cells without damaging healthy tissue. Significantly, this allowed the re-growth of normal cells.

Thirteen male patients aged 49-85, all diagnosed with esophageal adenocarcinoma, were enrolled in this study intended to determine the optimal energy density and treatment parameters to achieve the complete removal of human esophageal epithelium. The study was designed as a pilot trial leading up to the use of this device in patients with Barrett's.

Patients underwent randomization into three groups, with each group receiving slightly different energy doses when treated with the HALO³⁶⁰ System. Endoscopy was performed, followed by positioning of the HALO³⁶⁰ ablation catheter within the esophagus.

The procedure is performed without incisions, under conscious sedation, and requires an average of less than 30 minutes to complete. The physician first uses a HALO³⁶⁰ sizing balloon catheter to dilate the esophagus and determine its inner diameter. An ablation catheter is then inflated within the diseased area and the system's energy generator then delivers to the area a less than one second burst – which the company has described as a “flash burn“ not producing a great deal of heat – to the area, removing less than a 1 mm layer of diseased tissue.

New healthy tissue replaces the ablated Barrett's tissue in three to four weeks for most patients, according to the trial results.

In this particular study, the treatment was followed by a total esophagectomy (removal of the esophagus) as indicated by the cancer diagnosis – a part of the stomach pulled up and used as a substitute esophagus in a highly invasive procedure (but necessary without any other treatment available). Pathological evaluation was performed on the ablated segments to determine the ablation depth and completeness of epithelial removal.

Results confirm that the HALO³⁶⁰ System is capable of removing the esophageal epithelium without causing untoward injury to the underlying structures. Some patients have minor discomfort which is managed with medication, and following treatment patients may resume acid suppression therapy.

Brian Dunkin, MD, associate professor of surgery and chief of the division of laparoendoscopic surgery at the University of Miami Miller School of Medicine, and his colleagues did most of the procedures and provided oversight of all of the pathology.

He told Medical Device Daily that the HALO³⁶⁰ system offers the opportunity of a “preemptive strike“ vs. eso-phageal cancer that is “extremely easy to use, [the effects] extremely reproducible and very well controlled.

“The data basically allowed us to choose the proper energy setting,“ with 10 joules and 12 joules being the most efficient, Dunkin said.

He noted that other systems tend to offer “point and shoot“ approaches. Rather than “pointing and cooking,“ HALO³⁶⁰ treatment is extremely uniform, he said. And some of these systems produce “strictures“ within the esophagus, a loss of elasticity and difficulty in swallowing, he added.

The HALO³⁶⁰ System was FDA-approved in 2001 but not commercialized until late 2004, with 2005 sales of about $1 million, according to the president of Barrx, Greg Barrett, whose name, of course, resonates rather ironically in this context.

“What we have been doing is pursuing a number of clinical studies to validate the technology as to both safety and efficacy, and we really wanted to understand better how the technology works,“ Barrett said, with the sale of a second-generation device now in full ramp-up.

“What we are trying to do is ablate this condition at a very early stage, and even at the late stage, to avoid an esophageal cancer. We have gone through exhaustive studies to demonstrate that we can successfully remove Barrett's esophagus and these studies are really a culmination.“

This most recent study, he said, “specifically was intended to validate the depth of penetration of the tissue as a result of applying the energy to the esophagus. It further validated [that] the energy penetrated the tissue to between 700 microns and 100 microns and did not penetrate the sub-mucosal tissue. “

In the largest study conducted (AIM-II Trial), 70% of patients were Barrett's-free at one year follow-up. Clearly, key to the success for Barrx will be the more rapid diagnosis of Barrett's esophagus and the awareness of clinicians that they can avoid prescribing a drug-only solution.

The opportunity to take share from a pharmaceutical regimen is huge. Barrett's is estimated to affect about 3.3 million adults in the U.S. with about 86,000 cases newly diagnosed each year. “Boomers“ especially may be at risk since the condition increases with age until a plateau is reached in the 60s, according to Barrx.

The company last presented three studies demonstrating the technology at Digestive Disease Week 2005 (MDD, May 19, 2005), and Barrett promised an increased number of HALO³⁶⁰ studies at Digestive Disease Week 2006, scheduled for May 20-25 in Los Angeles.