Medtronic said Thursday preliminary trial results show its implantable, electric weight loss device failed to prove more effective than a placebo in helping patients lose excess weight.
said Thursday preliminary trial results show its implantable, electric weight loss device failed to prove more effective than a placebo in helping patients lose excess weight.
The medical device company said the one-year study on the company’s implantable gastric stimulation device was affected by “factors including variances in trial execution and unplanned treatment changes.”
The device is a pacemaker-like product that electrically stimulates the stomach to treat severe and morbid obesity.
“While we are disappointed in these preliminary findings, we believe gastric stimulation remains a potentially attractive, minimally invasive therapy for obesity,” said Dr. Richard Kuntz, president of Medtronic Neurological and Obesity Management.
Medtronic said the failed trial has no impact on another company study, which looks at the device’s effectiveness in treating obese patients with diabetes.
Medtronic said it plans to conduct further clinical research to improve its overall understanding of the therapy. The company said it also hopes to apply for regulatory approval for the product.
The failed trial was started by medical device company Transneuronix in May 2004. The company was acquired by Medtronic for $260 million in July 2005 (see Medtronic Buys Transneuronix). The purchase represented Medtronic’s first move into the obesity market.
Medtronic Buys TransneuronixMedtronic announced the trial results after market close. Shares fell $0.77 to $55.18 in after-hours trading on the New York Stock Exchange.
Limited Impact
According to Wall Street analysts the news will have limited impact on the company.
It’s a minor setback in Medtronic’s efforts to establish an obesity franchise, said Glenn Reicin, an analyst for Morgan Stanley, in a research note.
Morgan Stanley“Importantly, it appears that the trial may have failed due to poor administration, as opposed to the technology,” he wrote.