Apollo Endosurgery concludes Lap-Band FDA post-approval study
The HERO Study was prospective, multi-center and non-randomized. It involved 652 patients from Canada and the U.S. The goal was to observe patients who removed the system five years after they completed the surgery.
The lower explant rate was at 39.4 percent, meeting criteria for the researchers’ primary endpoint.
“Results demonstrated in the HERO Study are consistent with what we see at bariatric practices who have appropriately tailored and prescriptive follow-up programs for their patients,” Todd Newton, CEO of Apollo Endosurgery, said. “We remain confident that the Lap-Band System is a great option for patients seeking medically relevant weight loss results at bariatric practices where these tailored follow-up programs are in place.”
The study started in June 2009 when the FDA granted conditional approval of the new Lap-Band System for patients living in the U.S.
“This study demonstrates that continued patient interaction and adherence to good Lap-Band aftercare principles by the surgeon’s practice will produce an effective, safe and durable outcome for patients who suffer from obesity,” Dr. John Olsofka, a lead investigator, said.
Organizations in this story
Apollo Endosurgery, Inc. 1120 S Capital of Texas Hwy Austin, TX 78746