Category: Products

A Closer Look: 3 Devices That Help Isolate and Heal Fistulas

When it comes to managing fistulas, not all tools are created equal.

For decades, clinicians have tried unreliable methods to manage effluent and protect surrounding skin. These improvised approaches often lead to skin breakdown, delays in healing, and frustration for both patients and providers.

Fistula Solution was created to change that.

Each device in the Fistula Solution lineup was designed by a Complex Abdomen Specialist with firsthand knowledge of the gaps in traditional care. The result? Three innovative devices that provide targeted solutions for fistula isolation and effluent management—built for real patients with real challenges.

Let’s take a closer look at each one.

1. Wound Crown

Best For: Single, small-bowel fistulas and ostomies

The Wound Crown is Fistula Solution’s original device and continues to be one of the most widely used tools in their lineup. It’s designed for straightforward, small-bowel fistulas or difficult ostomies that require consistent, reliable isolation.

Key Features:

  • Pre-shaped design that can be tailored to fit the patient
  • Can be used with all common accessory wound dressings
  • Helps direct effluent into a pouching system, helping the wound dressing to heal the wound.

This device is often the first choice for clinicians managing fistulas.

🔗 Learn more about the Wound Crown

2. Fistula Funnel

Best For: Small wounds with fistulas or fistulas without a stoma

Some fistulas develop in difficult-to-access areas—right up against a wound margin, for example. The Fistula Funnel was designed specifically for these cases. Its narrow base and tapered shape allow for precise placement without interfering with nearby tissue.

Key Features:

  • Ideal for tight or irregular spaces
  • Can be trimmed multiple ways to isolate different sized fistulas and redirect effluent into a pouch
  • Can be used to isolate medical tubes and drains

When placement options are limited, the Fistula Funnel gives clinicians a new, adaptable tool for control and containment.

🔗 Learn more about the Fistula Funnel

3. Isolator Strip

Best For: Large wound beds or multiple fistulas

Flexibility is key when managing complex cases. The Isolator Strip is a 14-inch, pliable strip that can be cut to length, shaped into a loop, or used to span side-to-side depending on the clinical need.

Key Features:

  • Easily customizable to fit wound shape or configuration
  • Can isolate multiple fistulas at once
  • Reinforces pouching systems and protects surrounding skin

This device offers maximum adaptability in even the most complicated abdominal wound environments.

🔗 Learn more about the Isolator Strip

Why It Matters

Each Fistula Solution device was created to provide clinicians with the tools they need to:

  • Isolate effluent
  • Protect the skin
  • Promote healing
  • Support better patient outcomes

By choosing a purpose-built device clinicians can improve comfort, reduce dressing changes, and restore dignity to patients navigating a difficult healing journey.

Explore More

Fistula Solution offers a growing library of clinical education, product demos, and application guides to help you get the most out of each device.

🔗 Visit the Knowledge Center to explore how each device works and when to use them.

Built by a Nurse. Designed to Heal.

The Story Behind Fistula Solution’s Life-Changing Devices

When it comes to managing fistulas, the standard tools haven’t changed much in over a century. Pouches, gauze, adhesives, and creatively improvised techniques are still commonly used.

But patients deserve more.

A Long History of Improvising

Fistulas have been around for centuries. One of the earliest documented cases dates back to 1825, when military physician Dr. William Beaumont treated a young man, Alexis St. Martin, who had been shot in the abdomen with a musket. With no modern options available, he used rags and leather strapping to manage the effluent.

Shockingly, similar improvised methods are still used today.

“Over the years of wound management, we really haven’t come all that far,”
explains Mary Anne, RN, Complex Abdomen Specialist and Inventor of the Wound Crown, Fistula Funnel, and Isolator Strip. “Many fistulas are still managed with gauze, frequent dressing changes, and adhesives.”

But complex abdominal wounds, especially enteric fistulas, require something built for the job.

Real Solutions for Enterocutaneous Fistula Care

Fistula Solution was created to address the gap between what patients need and what was available. The result is a lineup of clinician-designed devices that isolate effluent, protect skin, and support real healing.

These are not general supplies. They are purpose-built tools for patients facing real complexity.

The Fistula Solution Device Lineup

Fistula Solution currently offers three devices, each designed for specific clinical needs:

  • Wound Crown
    Ideal for single, small-bowel fistulas and high output ostomies. Named after Mary Anne herself, the “Fistula Queen.”
  • Fistula Funnel
    Designed for smaller fistulas or those located near wound edges.
  • Isolator Strip
    A flexible 14" strip that can be looped to isolate multiple fistulas or shaped to span wide wound beds.

Enterocutaneous fistula care devices from Fistula Solution
A closer look at the Fistula Solution device lineup: purpose-built tools that isolate effluent, protect skin, and support healing in complex abdominal wounds

Each device directs effluent into a pouching system, giving patients the freedom to eat, move, and heal without constant dressing changes or skin breakdown.

Why Our Approach to Enterocutaneous Fistula Care Works

Before these devices existed, clinicians were MacGyvering — cutting, taping, and adapting whatever was available.

“Now we have something that actually fits,”
says Mary Anne.

The devices from Fistula Solution are:

  • Easy to apply
  • Pre-formed for common clinical needs
  • Designed to isolate the fistula or ostomy and protect the skin

No more guesswork. No more frustration. Just real tools that support better outcomes.

What Clinicians Are Hoping to Achieve

Whether it’s a surgeon, WOC nurse, or wound care team, the goal remains the same:

Isolate the fistula. Contain the effluent. Support healing.

Fistula Solution helps make that process more predictable, more effective, and more aligned with the realities clinicians face daily.

Ready to Learn More?

Fistula Solution is proud to support healthcare providers across the country with devices that make a difference in complex wound care.

🔗 Explore our Knowledge Center for product details, clinician tips, and educational tools:

Additional Resources:

Smithsonian Magazine: The gunshot wound that changed medicine.

Exciting Opportunities Await at SAWC Fall 2023!

Excitement is building as we gear up for SAWC Fall 2023, set to take place from November 2nd to 5th in the vibrant city of Las Vegas, Nevada. This event promises to be a hub of knowledge, innovation, and networking in the wound care industry.

1. Explore Booth #742

When you attend SAWC Fall 2023, make sure to add our booth, #742, to your must-visit list. Here, you'll find a treasure trove of information and the latest updates. But that's not all! Explore the convenience of purchasing our cutting-edge devices directly from Fistula Solution. You won't want to miss this chance to see a demonstration of our fistula devices up close and learn about our recent shift to direct distribution.

2. Complex Wounds or Fistulas? We've Got You Covered

For those grappling with challenging complex wounds or fistula cases, we have a special treat in store for you. At Booth 742, you can meet Mary Anne Obst from Complex Wounds and Fistulas. Mary Anne brings a wealth of knowledge and experience, and she's ready to collaborate with you to explore innovative solutions.

3. Dive Deeper

To learn more about our offerings and how we can help you tackle complex wound care challenges, be sure to visit our website at Fistula Solution. Here, you'll find additional information, resources, and a glimpse of what you can expect when you engage with us at SAWC Fall 2023.

In conclusion, SAWC Fall 2023 is an opportunity you won't want to miss. Whether you're looking for the latest wound care solutions, insights on complex wound cases, or simply eager to network with industry experts, we've got you covered. Be prepared for a productive and enlightening experience at this year's SAWC Fall.

For all the event details and updates, don't forget to visit the official SAWC Fall 2023 website at www.sawcfall.com. We can't wait to see you there!

Fistula Solution Releases Improved Fistula Funnel!

Fistula Solution is delighted to announce enhancements to our Fistula Funnel! Building on its success, the Fistula Funnel will maintain its exceptional features, including its tapered, flexible design and a 2-centimeter inside center diameter. However, based on valuable feedback from clinicians, we have implemented several performance enhancements, ensuring an even more effective and user-friendly experience. These enhancements include:

  1. Expanded Sizing Options: We have widened the end openings of the Fistula Funnel, providing healthcare providers with a greater range of sizing choices. This improvement enables clinicians to tailor the funnel precisely to individual patient needs.
  2. Streamlined Design: Our team has optimized the Fistula Funnel to fit in narrow situations. This streamlined design improves usability in crevices and near side walls.
  3. Intuitive Tailoring: In response to user feedback, we have introduced a new exterior scribe line to the Fistula Funnel. This innovative addition simplifies the tailoring process, making it more intuitive for clinicians.

The Fistula Funnel represents our smallest diameter barrier ring option, designed to compress the skin surrounding an enteric fistula, stoma, or drain. Its primary purpose is to create a secure seal that effectively protects the skin from effluent. This remarkable device is particularly suitable for:

  • Small-sized fistulas and stomas
  • Sidewall fistulas
  • Challenging crevice areas
  • Isolating fecal management system leakage

At Fistula Solution, we are dedicated to continuously improving our products to meet the evolving needs of clinicians and patients. With these enhancements to the Fistula Funnel we remain committed to providing the highest quality solutions for managing enteric fistulas and stomas.

Stay tuned for further updates and information on how the enhanced Fistula Funnel can revolutionize your clinical practice.

Click here to learn more.

Fistula Solution Distribution Changes

3M’s distribution agreement for Fistula Solution® devices will end August 22, 2023.  As we approach the end date there will be a point where these products will no longer be available for purchase through 3M.

For our esteemed customers in the United States, we want to assure you that Fistula Solution devices will continue to be available directly from Fistula Solution. To ensure a seamless transition and uninterrupted supply, we kindly request that US customers visit our Order page before July 30, 2023, to update their Fistula Solution account information and establish their ordering process.

To our customers outside of the United States, we regret to inform you that Fistula Solution devices will be temporarily unavailable until we reestablish distribution channels. We understand the inconvenience this will cause for our providers and patients, and we sincerely apologize for this unfortunate situation.

Our primary objective is to minimize the impact of these changes while simultaneously improving our products and services. As part of this transition, our US customers will have access to new options such as express/overnight shipping, a new mixed device pack, and P-card ordering. These enhancements are aimed at benefiting both patients and providers, and we are thrilled to have the opportunity to serve you in this capacity.

We deeply value your continued support, and we remain committed to our priorities of healing the patient and assuring health care providers are successful in the delivery of care.

Thank you for your understanding and cooperation throughout this transition period.

Sincerely,

Your Fistula Solution Team.

Fistula Solution Receives FDA Breakthrough Device Designation for Innovative Limpet Device, Advancing Enterocutaneous Fistula Care

  • Breakthrough Device Designations are given by the U.S. FDA to expedite the review of technologies that can improve the lives of people with life-threatening or debilitating conditions.
  • Each year, tens of thousands of Americans suffer from enterocutaneous fistulas (ECF).
  • With Breakthrough Device Designation the Limpet™ Device could become available as a new treatment option sooner for these patients.

Fistula Solution, a leading medical device company in complex wound care, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Limpet™ device for severe abdominal openings unlikely to spontaneously close. This device is designed to reduce current complications associated with enterocutaneous fistulas, which has the potential to reduce healthcare costs and improve patient confidence and quality of life.

Enterocutaneous and other enteric, or intestinal, fistulas are challenging to manage, and the current standard of care is costly. In terms of charges billed to patients, the median total charges per hospital stay are $50,451, with a range of $24,439 to $109,4343.  The annual costs of enteric fistulas on the healthcare system are estimated to be close to $500,000,000. Additionally, the charges incurred by enteric fistula patients amount to approximately $1.5 billion.  These figures indicate the significant financial burden that enteric fistula patients impose on the healthcare system, highlighting the importance of effective management and prevention strategies for this condition.

The Limpet combines key aspects of fistula management — effluent containment and negative pressure wound therapy for effluent management and promotion of healing of intact and injured skin. The protection of the negative pressure dressing also simplifies nursing care, eliminates the need for frequent dressing changes, and protects the surrounding skin or wound, which all promote the patient’s global health.

“The Breakthrough Device Designation is a significant milestone for our company and validates our belief that the Limpet™ device has advantages over the current standard of care,” said Andy Obst, President of Fistula Solution. “Early clinical results are promising and suggest our device reduces the complications typically associated with fistulas and ostomies and better supports a patient’s ability to get back to life. We look forward to working with the FDA to make the technology accessible as quickly as possible.”

Early clinical data comparing the Limpet with the current standard of care demonstrated that the Limpet achieves a 99.4% average reduction in skin damage area or near total control of intestinal effluent for patients with enteric fistula complications. The Limpet was worn for an average of 3 days versus the 0.26 days for conventional dressings and showed zero leak failures in 14 device placements over 65 days of therapy, reducing patient or caregiver maintenance.  Additionally, patients with new skin grafts around their fistula experienced 95% graft take, which is remarkable because grafting around stomas is generally not feasible with conventional dressings.

The FDA Breakthrough Device program is designed to help accelerate the development and approval of medical devices and products that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.  Receiving the Breakthrough Device Designation also facilitates the Medicare coverage for the device, which will help the Limpet device become more widely accessible for patients who require an ostomy procedure or develop enteric fistulas, benefitting both the healthcare system and the patient.

 

About Fistula Solution

Fistula Solution has a portfolio of devices designed to treat enteric fistulas and high output ostomy stomas. The company is committed to developing innovative new devices for post-surgical ostomy complications, rectovaginal fistulas, surgical drain wounds, and necrotizing soft tissue infections.

For further information visit www.fistulasolution.com.

 

  1. Moisture-Associated Skin Damage (MASD) | WoundSource
  2. Taneja, Charu, et al. "Clinical and economic burden of peristomal skin complications in patients with recent ostomies." Journal of Wound, Ostomy, and Continence Nursing 44.4 (2017): 350.
  3. Brooks NE, Idrees JJ, Steinhagen E, Giglia M, Stein SL. The impact of enteric fistulas on US hospital systems. Am J Surg. 2021;221(1):26-29. doi:10.1016/j.amjsurg.2020.06.017