Medical Device Daily Contributing Writer

SAN DIEGO — If the least-invasive surgical procedure, gastric banding, produces enough weight loss for improvement mentally and physically, then why aren’t more patients having bariatric surgery?

Marc Bessler, MD, surgical director at Columbia University (New York), said he feels that “many of them are afraid of the surgery.” In the “Emerging Endolumenal Technologies in the Treatment of Obesity” workshop that he moderated at last month’s annual meeting of the American Society for Bariatric Surgery (ASBS; Gainesville, Florida) here, several new approaches were presented that address patients’ fears of going under the knife.

One new group of procedures is that of endolumenal suturing, in which the suturing instrument is introduced through the esophagus — avoiding an abdominal incision — and is used primarily for stomach remodeling or gastrectomy.

These include Ethicon Endosurgery ’s (Cincinnati) Bariatric Edge Spiderman, which has a curved needle for stomach reduction. USGI ’s (San Clemente, California) G-Prox reduces the size of both the stoma and the gastric pouch. C.R. Bard ’s (Murray Hill, New Jersey) Endocinch can reduce the size of the stomach and the company also is developing a “quilt-like” approach to reducing stomach size.

Other than the latter approach, all of these are revisional surgeries designed for correcting a failed surgery as opposed to a primary procedure.

The next category of new procedures uses the endolumenal placement of a device. ValenTx (Wilson, Wyoming) uses “T” fasteners to attach a sleeve in the esophagus that then runs into the small bowel in order to avoid hormonal feedback that sends hunger signals back to the brain. Satiety (Palo Alto, California) uses endoscopic staples to produce a sleeve gastrectomy and has early results in humans showing a 20% to 25% excess weight loss at six months. GI Dynamics (Newton, Massachusetts) has placed its implanted sleeve endoscopically in both animals and humans and has found no migration and no complications so far.

When asked to predict what will become a winning strategy for these new products, Bessler said, “Durability and data will drive usage of new products. Durability will be an issue. Will staples outlast an artificial sleeve inside the gut? Data will drive the usage of anything new.”

When asked how good the data will have to be, he replied, “Everything is a trade-off. Thirty percent excess weight loss is good at two years out, but will some of these products still be inside the patient at the two-year mark? Durability, weight loss and tolerable side effects are all variables — it is all a matter of risk vs. benefit and the patient determines much of that equation. Patients have more and more input into their healthcare decisions, which is why so many of them choose not to have the life-saving surgery.”

Bessler prophesized that patients in the future may have repeat less-invasive procedures performed serially; or that many of these newer procedures could be used in tandem with each other, or with current devices such as the Lap-Band which is made by Allergan (Irvine, California). “There will be many choices for many patients, and it will be up to them to decide which fits best with their profile,” he said.

Barriers to entry into the bariatric surgery space are low, since even a modest weight loss results in resolution, even partially, in the associated co-morbidities. Patient expectations are satisfied with a modicum of success because it improves their quality of life. The numbers of treatable patients exceeds most other medical markets in terms of size, and even with a modest market share, a company should be able to enjoy profitable returns. There is enough of this giant pie to go around. For these reasons, as well as humanitarian ones, many new companies are developing non-surgical approaches to treat obesity.

Although the ASBS focuses on healthcare and medical necessity — not cosmetics—the real opportunity may lie in the consumer market, often referred to as “Lifestyle Medicine.” Not to be overlooked is the fact that Americans spend $30 billion annually on weight loss programs, pills and nutritional supplements in order to manage their weight.

With this as a backdrop, one wonders how much would an overweight person spend to lose weight if he or she could get a minimally invasive, reversible or temporary procedure done in an office or outpatient setting? It is not inconceivable that with some of the newer devices that avoid major surgery and can be performed in an office or outpatient setting, patients could self-pay and have a weight loss procedure by choice before they become obese.

Lifestyle medicine is one of patient demand over medical necessity, and is predicted to be one of the fastest-growing areas of healthcare investment today, primarily due to the large group of baby boomers who have discretionary income. Boomers could expand this already huge market to include the overweight and not just the obese.

In just a few years, it may be possible for a moderately overweight mother to elect to have an intragastric balloon placed in her stomach six months before her daughter’s wedding, as insurance that she looks her best — and thinnest — on that most important day.