EndoStim announced that Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) approved its Lower Esophageal Sphincter (LES) Stimulation System for Gastroesophageal Reflux Disease (GERD). EndoStim is currently available in Europe, Asia and several other countries in Latin America such as Chile and Colombia.
EnteroMedics reported that it has submitted its pre-market approval application for FDA review of its Maestro Rechargeable System’s VBLOC vagal blocking therapy as a treatment for obesity
This is an important step for an implantable device company that faced very tough times in 2009 after its US clinical trial failed to meet a critical effectiveness goal. EnteroMedics conducted a pivotal trial, and believes that the data are positive, leading it to submit the PMA application.
According to the press release, EnteroMedics president & CEO Mark Knudson said that “the Maestro System is a unique, neuroscience-based approach to the treatment of this epidemic disease, one which offers the potential to fill a significant gap in the obesity treatment spectrum. In the hundreds of patients treated to date, in addition to showing clinically meaningful weight loss, VBLOC Therapy has demonstrated an excellent benefit-to-risk profile; a criterion identified by the Agency as central to the review and approvability of new obesity treatment devices.”
Leptos Biomedical was founded in Fridley, MN in 2002 by Dr. John D. Dobak. Leptos intended to develop an implantable device to stimulate the greater splanchnic nerve, that was hoped would result in reduced food intake and increased energy expenditure.
In February 2010 Leptos announced its closure. Reasons were not provided, but it has been suggested that the decision was prompted by the 2009 announcement by competitor EnteroMedics’ that it had failed to meet the primary goals of its pivotal study. EnteroMedics’ Maestro device didn’t perform any better than a sham device. EnteroMedics is now conducting a new study with the device.
Click here for Leptos Biomedical’s patents.
Intrapace was founded in Mountain View, CA by Mir Imran in 2001 to develop an implantable system for the treatment of obesity. Once implanted and activated, the Abiliti system is designed to detect when a person consumes food or drink. When food or drink is detected, the system delivers a series of low-energy electrical impulses to the stomach intended to create a feeling of fullness.
In January 2011 Intrapace received the CE Mark for the Ability system.
The Ability IPG connects to the stomach via a lead that integrates the food sensor and stimulation electrodes. The sensor is able to detect food and drink and can trigger the abiliti stimulator device to create a feeling of fullness. These eating events, along with physical activity the patient engages in, are automatically recorded and available for downloading to a personal computer using the connect.abiliti Wand. Continue reading
Transneuronix, Inc. was founded in 1995 and was based in Mount Arlington, New Jersey. It was acquired by Medtronic in 2005.
Before its acqusition by Medtronic, Transneuronix developed the Transcend, an implantable gastric stimulator device for the treatment of obesity by electrical stimulation of the stomach. Later, Medtronic developed the Transcend II IPG. Continue reading
EnteroMedics Inc. was founded in St. Paul, MN in 2002 to develop a platform for vagus-nerve stimulation, primarily for obesity management. In March 2011 EnteroMedics received the CE Mark for its second-generation system – the Maestro RC.
The EnteroMedics Maestro RC device delivers VBLOC® vagal blocking therapy to through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. VBLOC Therapy is intended to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness. Continue reading