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Showing posts with label EnteroMedics. Show all posts
Showing posts with label EnteroMedics. Show all posts

Monday, September 5, 2011

EnteroMedics : Presentation of Maestro(R) RC System Clinical Data at the XVI World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders

09/02/11 -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases, and other gastrointestinal disorders, announced that data from the Company's VBLOC-DM2 ENABLE (DM2) trial evaluating the Company's second generation Maestro RC System in the treatment of obesity, diabetes and hypertension, was presented at the XVI World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), held August 31 to September 3 in Hamburg, Germany. The oral presentation, titled "Treatment of Obesity-Related Co-Morbidities with VBLOC Therapy," was delivered by Miguel Herrera Hernández, M.D., Instituto Nacional de la Nutrición, Mexico, an investigator in the DM2 trial.

EnteroMedics

DM2 trial results presented at IFSO reflect statistically significant, sustained improvement in glycemic control and blood pressure, as well as clinically meaningful weight loss in obese, diabetic patients using the Maestro RC System. The 18-month data presented at IFSO included: excess weight loss (EWL) of approximately 24.6% (n=22), a mean reduction in HbA1c of 1.2 percentage points from a baseline of 8.1% (n=13), a change in fasting plasma glucose of -38.4 mg/dl from a baseline of 151.4 mg/dl (n=12) and, in hypertensive patients (n=10), a reduction in mean arterial pressure of 13.0 mmHg from a baseline of 99.5 mmHg and a reduction in diastolic blood pressure of 15.9 mmHg from a baseline of 87.2 mmHg (n=10). Through 18 months, no change in mean arterial pressure was observed in patients that did not present with hypertension (n=10)... EnteroMedics' Press Release -

Wednesday, June 23, 2010

EnteroMedics : Data From VBLOC-DM2 ENABLE Study to Be Presented at American Society for Metabolic and Bariatric Surgery Meeting

EnteroMedics Jun 22, 2010 -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that updated clinical results from the Company's VBLOC-DM2 ENABLE (DM2) study will be presented on June 26, 2010 at 11:30 AM PT at the 27th Annual Meeting of the American Society of Metabolic and Bariatric Surgeons (ASMBS), being held June 21-26 in Las Vegas, NV. The Company also announced updated data from its EMPOWER(TM) study in obesity.

"The Maestro System has been studied in over 400 people to date, with some patients into their fifth year of follow-up," said President and CEO Mark B. Knudson, Ph.D. "Across a number of studies, we have observed clinically significant weight loss and control of obesity related co-morbidities as well as a safety profile that distinguishes this system from all other bariatric surgical procedures. We are particularly encouraged by the strong, positive feedback from the metabolic and bariatric surgery community."... EnteroMedics' Press Release -

Wednesday, July 23, 2008

EnteroMedics : ISO 13485:2003 Certification for the Maestro(TM) System

Jun 27, 2008 - EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that it has received ISO 13485:2003 certification from KEMA Quality B.V. for the design, manufacture and distribution of surgical implants and associated accessories for nervous impulse modulation for the purpose of regulating gastrointestinal and metabolic disorders. EnteroMedics is in pivotal testing of VBLOC(TM) vagal blocking therapy, delivered via the Maestro(TM) System, for the treatment of obesity... EnteroMedics' Press Release -

Monday, March 10, 2008

EnteroMedics, Expansion of EMPOWER Pivotal Study for Obesity to 300 Patients

Feb 26, 2008 - EnteroMedics Inc., (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that the Food and Drug Administration (FDA) has granted approval for the expansion of its pivotal clinical trial, known as the EMPOWER Study, from 220 patients to 300 patients. Full enrollment in the EMPOWER Study is expected in the first half of 2008, consistent with previous projections, despite expansion of the study.

The EMPOWER Study, which is currently enrolling patients at 10 of its projected 15 clinical sites, is a randomized, double-blind, placebo-controlled study being conducted to evaluate the safety and effectiveness of investigational VBLOC(TM) vagal blocking therapy using the Maestro(TM) System in obese patients. VBLOC Therapy is designed to empower weight loss by promoting earlier feelings of fullness and reduced hunger while minimizing the side effects and complications associated with existing surgical options and preserving the individual's normal anatomy... EnteroMedics' Press Release -

Wednesday, January 9, 2008

EnteroMedics, Nine-Month Clinical Results on Its VBLOC-RF2 Feasibility Study for Obesity Therapy

Jan 08, 2008 - EnteroMedics Inc. (NASDAQ:ETRM), a developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced interim clinical results for the company's Maestro(TM) RF2 System. The Maestro RF2 System is currently being evaluated in 33 obese patients outside the United States in the VBLOC-RF2 clinical feasibility study of the company's proprietary VBLOC(TM) vagal blocking therapy... EnteroMedics' Press release -