Eclipse™ System for Bowel Control for the Treatment of Fecal Incontinence

Eclipse™ System for Bowel Control for the Treatment of Fecal Incontinence

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You may feel like no one talks about bowel leakage, but that doesn’t mean no one is suffering. Women of all ages experience varying degrees of loss of bowel control, with the average age of onset being 47 to 55.1, 6. 1 out of 11 adult women struggle with bowel control 3, yet over 70% of women remain silent 4.

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Why the Eclipse System for Bowel Control?

Immediate Results: In the LIFE Study, 8 of 10 women who were successfully fit with the Eclipse System reported treatment success during 1-month of use.6

No Surgery Required: The Eclipse System is fit and provided in a physician’s office

Easy to Use: The vaginal insert is easy to place and easy to remove. Women can insert and remove the Eclipse System whenever they want.

What is Loss of Bowel Control?

The inability to control one’s bowels which results in the leakage of stool – also known as Accidental Bowel Leakage (ABL) or Fecal Incontinence (FI) – is a real medical condition, and not merely a symptom of aging. Nerve or muscle damage in the pelvic region can affect bowel control, as can diarrhea, Irritable Bowel Syndrome or other gastrointestinal conditions. It can be embarrassing, even devastating in the wrong circumstances. Women who lose control of their bowels often feel like they have lost control of their life.

What are the Symptoms?

Loss of bowel control symptoms are varied. Common symptoms include:

  • Urgency: Sudden, strong urge to have a bowel movement
  • Passive soiling: Passing stool without knowing it
  • Incomplete emptying: “Can’t get it all out” during a bowel movement; the remaining stool can leak out later on

Accidents can range from large to small to just stains in your underwear.  Sufferers may have some good days and some bad days, or may have accidents every day.  Women with bowel control issues may visit the bathroom frequently, and many report fearing a simple trip to work or the grocery store, and missing out on valuable time with friends and family. Unfortunately, many don’t bring it up with a doctor.

The Eclipse System was developed to provide an effective, in-office, non-surgical treatment option for patients unsatisfied with current treatment solutions. In fact, the American College of Obstetricians and Gynecologists (ACOG) has a recommendation for non-surgical treatments (including Eclipse) as initial management of Fecal Incontinence.5

The Eclipse System offers a wearable, yet removable, rectal control system with immediate results without pharmaceutical side-effects or the recovery time seen with traditional surgical treatments.

The vaginal balloon is placed similarly to a tampon or pessary, which, when inflated, expands to compress the rectum, thereby preventing the accidental passage of stool.

The Eclipse system can be used as an initial management of fecal incontinence, or in combination with other therapies, including diet modification, pelvic floor stimulation or therapy, medications, Sacral Neuromodulation, or previous surgical procedures.5

LIFE Study

The Eclipse System was studied in a multi-center clinical trial in the United States, called LIFE. The LIFE Study demonstrated the effectiveness and safety of the Eclipse System. One hundred and ten women who were eligible to be fitted with the Eclipse Insert enrolled in the study. Sixty-one women achieved a successful fit and went on to a one-month evaluation period.

The LIFE study was led by Holly E. Richter, Ph.D., M.D., Director of the Division of Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham, and past President of the Society for Gynecological Surgeons (SGS). Primary results of this study were published in Obstetrics & Gynecology, and an additional analysis of the impact of Eclipse on bowel symptoms associated with ABL was published in Diseases of the Colon and Rectum.

Success defined as >50% reduction in accidental bowel control episodes.6 Zero serious device-related adverse events were reported in the study. All device-related adverse events were rated as mild (78%) or moderate (22%). The majority of adverse events were experienced during the fitting period. There were substantially fewer occurrences once subjects were successfully fit with the device and entered treatment. The most common adverse event was pelvic cramping and discomfort, and other observed events included pelvic pain, vaginal spotting and urinary incontinence. 110 women participated in the fitting process, and 61 of those women entered the study; those who discontinued did so mostly for fit-related reasons. Those who were fit experienced a reduction from an average baseline of 6 episodes per week to 1 episode per week after 1 month of wear. Reference: LIFE Study6

Sizer Reusable sizing tool, representing the insert base.  Intended to aid in selecting appropriate Trial Insert sizes.  Sizers are only to be used in the clinical setting and are not intended to be taken home. 48mm, Round SZ02-48RD
51mm, Round SZ02-51RD
57mm, Round SZ02-57RD
64mm, Round SZ02-64RD
70mm, Round SZ02-70RD
76mm, Elliptical SZ02-76EP
Trial Insert Single-patient-use vaginal insert intended for short term use (approximately 1 week, but no more than 2 weeks) during the fitting and evaluation process.  The Trial Inserts are identifiable by their white color. 48mm, Round, Small TR02-48RDS
51mm, Round, Small TR02-51RDS
57mm, Round, Small TR02-57RDS
48mm, Round, Regular TR02-48RDR
51mm, Round, Regular TR02-51RDR
57mm, Round, Regular TR02-57RDR
64mm, Round, Regular TR02-64RDR
70mm, Round, Regular TR02-70RDR
76mm, Elliptical, Regular TR02-76EPR
Eclipse Insert Single-patient-use vaginal insert intended for longer-term use (up to one year).  The Eclipse Inserts are identified by their indigo color. 48mm, Round, Small EC02-48RDS
51mm, Round, Small EC02-51RDS
57mm, Round, Small EC02-57RDS
48mm, Round, Regular EC02-48RDR
51mm, Round, Regular EC02-51RDR
57mm, Round, Regular EC02-57RDR
64mm, Round, Regular EC02-64RDR
70mm, Round, Regular EC02-70RDR
76mm, Elliptical, Regular EC02-76EPR
Pump The Pump is used by the patient for inflating and deflating the Insert Balloons.  The pump is packaged with the medium Regulator and a Patient Instructions For Use Booklet. Single configuration PP02
Valve (5 pack) Each Insert (Trial or Eclipse) is packaged with a Valve.  A replacement Valve will be provided to a patient in the case of damage or irreversible soiling of the valve on their insert. Single configuration VV04
Regulator (5 pack) The medium Regulator is provided with the pump.  The low or high Regulator can be used to provide lower or higher maximum balloon pressure levels. Low Pressure RR02-LOW
Medium Pressure RR02-MED
High Pressure RR02-HIGH
Extension Tube (5 pack) Additional tubing to be used as needed to customize the tube length insert. Single configuration TT02
Storage Cart Storage cart to hold Eclipse product and patient materials 4 drawer – single configuration ECLCRT01
Quick Start Kit

Kit includes: 11 Sizers, 14 Trial Inserts, 3 Pumps, Accessories (5 each of Valves, Regulator-Low, Regulator-High, Extension Tubes), 1 Storage Cart Quick Start Kit – Base ECLBDL01
Kit Includes: 11 Sizers, 14 Trial Inserts, 14 Eclipse Inserts, 3 Pumps, Accessories (5 each of Valves, Regulator-Low, Regulator-High, Extension Tubing), 1 Storage Cart
Quick Start Kit – 14 Pack of Eclipse Inserts ECLBDL03
Kit Includes: 11 Sizers, 14 Trial Inserts, 5 Eclipse Inserts, 3 Pumps, Accessories (5 each of Valves, Regulator-Low, Regulator-High, Extension Tubing), 1 Storage Cart Quick Start Kit – 5 Pack of Eclipse Inserts ECLBDL04
  • Procedure Type: Treatment of accidental loss of bowel control in women
  • Eclipse™ Base Sizes: 48mm, 51mm, 57mm, 64mm, 70mm, 76mm (Elliptical)
  • Trial Balloon Sizes: 48mm (Regular/Small), 51mm (R/S) 57mm (R/S), 64mm (R), 70mm (R), 76mm (Elliptical)
  • Eclipse™ Balloon Sizes: 48mm (Regular/Small), 51mm (R/S) 57mm (R/S), 64mm (R), 70mm (R ), 76mm (Elliptical )
  • Pump: 1 size for Trial and Eclipse™
    Accessories: Regulators (Low, Medium, High), Valve, Tubing

The Eclipse™ Bowel Control system is reimbursed by CMS (A4563 – Vag inser rectal control sys). Private payer initiatives underway (Source: April 2021 DEMPOS fee schedule)

Eclipse Coding & Billing Guide

1 – Bharucha AE, Zinsmeister AR, Locke GR, et al. Prevalence and Burden of Fecal Incontinence: A Population-Based Study in Women. Gastroenterology. 2005;129(1):42–49.
2 – Lawrence et al. Prevalence and co-occurrence of pelvic floor disorders in community-dwelling women. Am College of Obstet Gynecol 2008
3 – Nygaard I, Barber MD, Burgio KL, et al. Prevalence of Symptomatic Pelvic Floor Disorders in US Women. JAMA. 2008;300(11):1311-1316
4 – Brown HW, MD, Wexner SD, MD, and Lukacz ES, MD. Factors Associated With Care Seeking Among Women With Accidental Bowel Leakage Female Pelvic Medicine & Reconstructive Surgery, Volume 19, Number 2, March/April 2013
5 – ACOG 2019 FI Practice Bulletin
6 – Richter HE, Matthews CA, Muir T, et al. A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence. Obstetrics & Gynecology. 2015; 125(3):540-547

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