Most recent update: Thursday, November 30, 2017 - 11:56

Bariatric News - Cookies & privacy policy

You are here

VBLOC Therapy

VBLOC Therapy demonstrates blood pressure reduction

Maestro System is nearing CE Mark certification
Data presented from a subgroup analysis of the EMPOWER trial

Data presented at the American Heart Association's 2012 Scientific Sessions, Los Angeles, has demonstrated that VBLOC vagal nerve stimulation therapy can reduce blood pressure in obese subjects.

The data comes from a subgroup analysis (Table 1) of the EMPOWER trial, a randomised, double-blind, controlled pivotal study designed to evaluate the safety and efficacy of the Maestro System using VBLOC Therapy in 294 obese subjects.

"The results of this sub study analysis are remarkable, in that VBLOC Therapy has demonstrated a clinically meaningful, non-pharmacologic, immediate and sustained reduction in blood pressure in obese subjects with hypertension," said Dr Robert M Carey, professor, Division of Endocrinology and Metabolism, University of Virginia Health System. "This effect suggests that VBLOC Therapy may offer the first, non-pharmacologic intervention for hypertension in obese subjects, a clinical outcome that, with available obesity surgical treatments, has never before been achieved."

Hypertension was defined as elevated blood pressure at baseline by JNC-7 guidelines (n=37, Group A) or history of hypertension (n=58, Group B) at baseline. The analysis was performed in a subset of subjects who had nine hours or more of therapy delivered per day to 12 months. The changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline can be seen in Table 2.

Table 1: Subject demographics

Group   A
  (Elevated Blood   Pressure)

Group   B
  (History of   Hypertension)

# of   Subjects

37

58

BMI (kg/m2)

41±1

41±1

Age (Years)

50±1

51±1

Female/Male  

31/6

47/11

 

Table 2: Changes in SBP and DBP from baseline

Group   A (Subjects with Elevated Blood Pressure) (P < .001)

Baseline

Week 2

Week 4

12 Months

SBP (mmHg)

145±2

-17±3

-17±3

-18±3

DBP (mmHg)

89±2

-9±2

-8±2

-10±2

% Excess   Weight Loss

N/A

9±2

12±1

21±4

Group   B (Subjects with History of Hypertension) (P < .001)

Baseline

Week 2

Week 4

12 Months

SBP (mmHg)

134±2

-10±2

-9±2

-13±2

DBP (mmHg)

84±1

-6±1

-6±1

-7±1

% Excess   Weight Loss

N/A

9±1

13±2

23±3

"These data suggest that VBLOC Therapy may significantly reduce blood pressure in obese subjects with hypertension, an effect which appears to be independent of weight loss and achieves a greater magnitude of reduction at higher baseline blood pressure values,” said Dr Mark B Knudson, EnteroMedics' president and CEO. “These data add to our extensive clinical experience with VBLOC Therapy and the Maestro System in obesity and its related co-morbidities of hypertension and diabetes. We have begun the process of amending our CE Mark certification to include these effects on hypertension and diabetes, adding to our obesity certification."

VBLOC Therapy is delivered via the Maestro System through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. VBLOC Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.

The newer Maestro RC System is powered by an internal, rechargeable battery. The battery is recharged as needed via an external mobile charger and transmit coil.

Want more stories like this? Subscribe to Bariatric News!

Bariatric News
Keep up to date! Get the latest news in your inbox. NOTE: Bariatric News WILL NOT pass on your details to 3rd parties. However, you may receive ‘marketing emails’ sent by us on behalf of 3rd parties.