Regulators have approved Irvine-based Allergan Inc.’s Lap-Band weight-loss device for more patients.
The move expands the use of the surgically implanted adjustable silicon stomach band to patients who are overweight but aren’t morbidly obese by federal guidelines.
Under new Food and Drug Administration rules, Lap-Band could be used for someone with a body mass index of 35, or even 30 for those with complications from diabetes and other conditions.
That expands Lap-Band’s use from people with a body mass index of at least 40, or 35 with other conditions.
A body mass index of 20 to 25 is considered optimal. Some 70% of American adults are considered overweight or obese by body mass standards.
“I absolutely remain convinced that Lap-Band’s going to be a very big product,” Allergan Chief Executive David Pyott told the Business Journal earlier this month. “People certainly aren’t getting any thinner.”
Lap-Band, which is widely promoted by doctors on billboards and TV, generated $243 million of Allergan’s $4.9 billion in 2010 sales.
The company is being cautious in its projection for Lap-Band sales this year, even with expanded use.
2011 sales of the device could come in at $220 million to $240 million, according to Allergan, which issued an overall conservative yearly forecast earlier this month.
Most Lap-Band procedures still are paid for by patients themselves, prompting Allergan to be cautious about sales.
Lap-Band surgery costs about $12,000 to $20,000.
Getting more insurers to pay for Lap-Band is “something we have got to work on,” Pyott said.
Preferred-provider organization plans, which usually require members to shoulder a greater percentage of healthcare expenses, now cover some but not all of the costs of the surgery.
The device faces other challenges.
In recent weeks, Lap-Band has come under some regulatory and media scrutiny after several deaths were linked to the surgery.
Allergan acquired Lap-Band through its $3 billion buy of Santa Barbara’s Inamed Corp. in 2006.
