Renew Medical05.24.16
Renew Medical Inc. (Renew) has launch in the United States the Renew Insert, a silicone rectal insert device available by prescription for patients with accidental bowel leakage (ABL). The Centers for Disease Control estimates that ABL or fecal or bowel incontinence affects 17 percent of people 65 years of age or older.1 A majority of ABL sufferers report a significant quality of life disruption, yet only a small number of those affected (approximately one in 10) have been clinically diagnosed.2
The Renew Insert is a discreet, easy-to-use device that is designed for self-insertion to comfortably seal the rectum from the inside to help prevent ABL. Renew Inserts are delivered directly to the patient's home. The product is made of soft and flexible silicone and is suitable for use for women and men. The Renew Insert provides protection from solid and liquid stool leakage and is indicated for continuous use. Renew Inserts are designed for single-use and are naturally expelled with a bowel movement.
"Renew Inserts are a new way to manage ABL. They are very soft, comfortable, convenient, safe, and easy to use. Most of my patients have been thrilled with the results," said Dr. Emily S. Lukacz, division director, Female Pelvic Medicine and Reconstructive Surgeryat the University of California-San Diego Health System.
A published U.S. clinical study showed the Renew Insert is safe to use and the device reduces ABL by 82 percent.3 Users of Renew Insert rated overall satisfaction at 4.8 out of 5 after nearly three years of continuous use.4
Renew Medical conducted a multicenter, prospective, single-arm, non-randomized pivotal study designed to establish the safety, effectiveness, and tolerability of the Renew Insert in patients with moderate-to severe accidental bowel leakage. The results included:
Renew Inserts have U.S. Food and Drug Administration clearance and CE Mark approval.
Renew Medical is a privately-held continence-care company that develops technology and devices for people suffering from accidental bowel leakage. The company researched, developed and clinically tested the Renew Insert for over seven years in the United States and Europe.
References:
1. CDC/DHHS Publication No. 2014-1420, Prevalence of Incontinence Among Older Americans, June 2014
2. Nielsen Mature Women's Health Survey commissioned by Renew
3. Dis Colon Rectum 2015; 58: 892-898
4. 35 month UK Consumer Panel - MKT-008 Study
The Renew Insert is a discreet, easy-to-use device that is designed for self-insertion to comfortably seal the rectum from the inside to help prevent ABL. Renew Inserts are delivered directly to the patient's home. The product is made of soft and flexible silicone and is suitable for use for women and men. The Renew Insert provides protection from solid and liquid stool leakage and is indicated for continuous use. Renew Inserts are designed for single-use and are naturally expelled with a bowel movement.
"Renew Inserts are a new way to manage ABL. They are very soft, comfortable, convenient, safe, and easy to use. Most of my patients have been thrilled with the results," said Dr. Emily S. Lukacz, division director, Female Pelvic Medicine and Reconstructive Surgeryat the University of California-San Diego Health System.
A published U.S. clinical study showed the Renew Insert is safe to use and the device reduces ABL by 82 percent.3 Users of Renew Insert rated overall satisfaction at 4.8 out of 5 after nearly three years of continuous use.4
Renew Medical conducted a multicenter, prospective, single-arm, non-randomized pivotal study designed to establish the safety, effectiveness, and tolerability of the Renew Insert in patients with moderate-to severe accidental bowel leakage. The results included:
- Reduction in the frequency of ABL episodes was measured by comparing pre-and post-treatment results on 85 patients who used the Renew Insert for at least one week or more during the 12-week treatment period.
- The study showed a median reduction of 81.8 percent in the frequency of ABL episodes when the Renew Insert was used.
- There were no reported severe, serious or unanticipated adverse events. Nearly all (98.7 percent) of the adverse effects possibly related to the Renew Insert were rated as mild and included the sensation of urge, irritation or soreness around the anal area.
- The reported overall satisfaction among the majority of Insert users was high, with 91.4 percent rating overall experience and ease of use rated as a 9.5 (median) on a 10 point scale.
Renew Inserts have U.S. Food and Drug Administration clearance and CE Mark approval.
Renew Medical is a privately-held continence-care company that develops technology and devices for people suffering from accidental bowel leakage. The company researched, developed and clinically tested the Renew Insert for over seven years in the United States and Europe.
References:
1. CDC/DHHS Publication No. 2014-1420, Prevalence of Incontinence Among Older Americans, June 2014
2. Nielsen Mature Women's Health Survey commissioned by Renew
3. Dis Colon Rectum 2015; 58: 892-898
4. 35 month UK Consumer Panel - MKT-008 Study