The Food and Drug Administration of the United States has approved VBLOC, the vagal blocking therapy of medical research company EnteroMedics, which will be administered through the company's Maestro System.
The therapy is for the treatment of adult patients suffering from obesity, and the Maestro System is the first new obesity-focused medical device that the FDA has approved in the past 10 years.
According to EnteroMedics, there is currently a significant need for the development of innovations in the treatment of the epidemic of obesity, which is happening worldwide. The VBLOC vagal blocking therapy of EnteroMedics looks to address the worldwide need, as obesity is contributing significantly to the ever-increasing costs of health care.
The therapy involves the human vagus nerve, which is tasked with the regulation of many processes in the body that affect digestion and stomach activities. Functions of the vagus nerve involve the enabling of several mechanisms in the human metabolic and gastrointestinal systems, including stomach expansion, stomach contraction, gastric acid release, stomach content release into the small intestine, digestive pancreatic enzyme secretion and the sensations of both hunger and fullness.
Early studies on the vagus nerve involved surgically removing the nerve, which was historically used to treat peptic ulcers. The results of such procedures typically resulted in weight loss and appetite reductions, but the effect was not sustainable due to the body compensating for the disruption in the human anatomy.
EnteroMedics designed the VBLOC therapy to be able to intermittently block the signals of the vagus nerve through the Maestro System, which is a pacemaker-like device that is implanted into the patient. The therapy minimizes the side effects of the surgical removal of the vagus nerve and eliminates the compensation the body will make for such a procedure.
The blocked signals by the VBLOC therapy will lead to reduced appetite levels and weight loss, with the reduction of stomach expansion and contraction. The therapy will also decrease calorie absorption through lower digestive enzyme secretion.
The Maestro System that delivers the therapy is implanted into the human body through a laparoscopic surgical procedure that is minimally invasive. The device is then non-invasively programmed by a physician to cater to the personal health needs of the patient.
The VBLOC therapy, as administered by the Maestro System, allows patients to address obesity without any restrictions to food intake and any adjustments to their lifestyle.
The Maestro System has a well-established safety record and has led to successful and sustainable weight loss. Patients that have received over 12 hours of VBLOC therapy daily through the device achieved more than 25 percent average excess weight loss over a period of 12 months.
Possible side effects, however, are connected to the minimal risks of any laparoscopic procedure, in addition to the possibilities of device malfunctions and allergic reactions to the device.
EnteroMedics expects the Maestro System to be released on limited availability in selected Bariatric Centers of Excellence in the United States within the year, but it will come with the hefty tag price of $15,000.
