Search Results

The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

The Vibrant System is designed to mechanically induce peristaltic activity in the colon, thus aiding in relieving constipated patients. Constipation relief is achieved by the Capsule's stimulation in the colon, consequently inducing peristaltic activity which promotes transit and facilitates defecation. The stimulation protocol is designed to activate at specific times during the day (i.e., afternoon and evening). The Vibrant System is comprised of two components: a reusable pod and a single use capsule. The Capsule is expelled from the body during the patient's bowel movements.

The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

The Vibrant System is designed to mechanically induce peristaltic activity in the colon, thus aiding in relieving constipated patients. Constipation relief is achieved by the Capsule's stimulation in the colon, consequently inducing peristaltic activity which promotes transit and facilitates defecation. The stimulation protocol is designed to activate at specific times during the day (i.e., afternoon and evening). The Vibrant System is comprised of two components: a reusable Pod and a single use capsule. The Capsule is expelled from the body during the patient's bowel movements.

The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

The Vibrant System is comprised of two components; a Pod and a single use Capsule. The Pod activates the Capsule using radio frequency (RF) communication. After activation, the Capsules are taken orally. After a pre-programmed activation delay, the Capsules begin to vibrate. The marketed device will have an activation delay of 14 hours. (The 14 hours activation delay corresponds to Active Mode 1 of the pivotal study described below: the pivotal study also included an Active Mode 2 with a 9 hour activation delay.) As they pass through the gastrointestinal tract, the Capsules vibrate for four pre-programmed periods of 100 min, 120 min, 100 min. 180 min. It takes about three days for the Capsules to pass through the gastrointestinal tract, at which point thev are excreted in a bowel movement. The Capsule is comprised of a motor that vibrates (2.5 Vdc. 70 ma), electronic card, batteries (2x 1.5V 60 mAh, alkaline/0% Hg coin battery) and connector. The capsule is a two-piece shell made from Polycarbonate Makrolon 2458. The Capsule dimensions are as follows: length: 24.5 ± 0.1 mm; diameter: 11.20 ± 0.05 mm; weight 4.0 ± 0.1 g. The Capsules have a vibration force between 200 and 550 gf, with vibration cycles of 3 seconds on and16 seconds off (190 cycles per hour).