Enterocutaneous Fistula – Fistula Solution

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:

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.
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.
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 Fiesta at WOW! Exploring Innovative Management Techniques for a Complex Challenge

Are you a dedicated healthcare professional seeking to expand your knowledge and skills in advanced wound care? Look no further! The Wild on Wounds (WOW) conference in Hollywood, Florida, is back with its impactful, hands-on wound care education. This year, the spotlight is on the "Fistula Fiesta" session - a unique opportunity to explore effective management techniques for the complex challenge of fistulas.

An Insightful Journey into Fistula Management

On September 16, 2023, the WOW conference will offer a comprehensive look into the management of fistulas. These challenging wounds can have a profound impact on both patients and their caregivers, making it crucial for healthcare professionals to stay informed about the latest advancements in treatment and care.

Unraveling the "Fistula Fiesta" Session

Designed specifically to address the complexities of fistulas, the "Fistula Fiesta" session will focus on the unique difficulties faced by patients and caregivers alike. Whether you're a nurse, a physical therapist, or an occupational therapist, this session will equip you with valuable insights and skills to effectively manage this intricate wound condition.

The Significance of Fistula Management

Fistulas pose significant challenges, often requiring a multidisciplinary approach to achieve the best outcomes for patients. Moreover, the psychological impact on patients and their families should not be underestimated. This session aims to illuminate the best practices in fistula management, empowering attendees to provide better care and support to their patients.

What You'll Learn

By attending the Fistula Fiesta session, you'll have the opportunity to achieve several key learning objectives, including:

Identifying three common types of fistulas that develop in patients.
Comparing different types of fistula management devices available on the market, allowing you to make informed choices tailored to your patients' unique needs.

Your Expert Guide - Emily Greenstein

Leading the Fistula Fiesta session is the experienced Emily Greenstein, APRN, CNP, CWON-AP, FACCWS, from Sanford Health in Fargo, ND. Emily's wealth of knowledge and expertise makes her the perfect guide to navigate the complexities of fistula management. With her board certifications in Wound and Ostomy Care and 14 years of experience, she is dedicated to advancing wound care practices and providing optimal patient outcomes.

Join the Fiesta, Enhance Your Expertise!

The Fistula Fiesta session at WOW promises to be an illuminating experience, providing you with valuable insights and skills to tackle the challenges of fistula management with confidence. Whether you're a seasoned healthcare professional or just starting your wound care journey, this session offers something for everyone.

Don't miss out on this enriching opportunity! Click here to learn more about the event and the Fistula Fiesta session.

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.

Moisture-Associated Skin Damage (MASD) | WoundSource
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.
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

Enteric Fistula Management at WUWHS Conference

The upcoming World Union of Wound Healing Societies (WUWHS) conference will be a hybrid format with a virtual option alongside the physical program to accommodate all who would choose to join in that manner. The exciting WUWHS program includes multiple sessions on enteric fistulas and management of the open abdomen.

Dee Waugh will cover the topic of "Enterocutaneous/enteroatmospheric fistula management", Mr. Ibby Younis will be presenting "Abdominal wall reconstruction: a new way", and Hayat Alsaleh will speak on "Open abdomen with complex EC fistula".

The 2022 WUWHS Hybrid Congress is March 1-5.

Fistula Focus at the Abdominal Wall Reconstruction Conference

The upcoming Abdominal Wall Reconstruction Conference includes soft tissue and hernia repair topics and a pair of exciting enteric fistula presentations. Dr. Robert Martindale from Oregon Health Sciences University will present "Focus on EC Fistula / Mesh Infection: Thoughts on the Staged Repair" and Mary Anne Obst, WOCN and Complex Abdomen Specialist at Regions Hospital, will present "EC Fistulas, Stomas, & Complex Wounds: A Nursing Perspective".

The 2022 Abdominal Wall Reconstruction virtual conference is June 8-11. Abstracts must be submitted by April 15, 2022.

Fistula Fun at Chicago WOCN Conference

The upcoming Professional Education Day of the Northern Illinois Affiliate of the Wound Ostomy and Continence Nurses Society (NIAWOCN) includes a pair of exciting enteric fistula presentations. Dr. Erik Borncamp, Medical Director for The Wound Center at Silver Cross Hospital, will present "Ostomy, Fistula and Open Abdomen". He will discuss the pathophysiology of fistulas and the challenges in closing them.

Mary Anne Obst, Complex Abdomen Specialist for Regions Hospital, will close the conference with her "Fun with Fistulas" presentation. She will cover assessment and classification of the enteric fistula patient, medical management and wound care principles.

The NIAWOCN's 23rd annual professional education day is October 13, 2021 from 7:00am-4:00pm CST at Bobak's Signature Events and Conference Center in Woodridge, Illinois.

Fistulas, Stomas, and Complex Wounds at the Abdominal Wall Reconstruction Conference

The Advanced Concepts session at the upcoming Abdominal Wall Reconstruction Conference includes soft tissue and hernia repair topics and a pair of exciting enteric fistula presentations. Mary Anne Obst, WOCN and Complex Abdomen Specialist at Regions Hospital, will present "EC Fistulas, Stomas, & Complex Wounds: A Nursing Perspective". Mary Anne will be followed by Eric Pauli, MD from Penn State Health Milton S. Hershey Medical Center who will present "Surgical Management of the EC Fistula Patient".

The Advanced Concepts session will conclude with a panel discussion including best practices in fistula management.

The 2021 Abdominal Wall Reconstruction conference has adapted to an invigorated online conference June 9-12. Abstracts must be submitted by April 16, 2021.

Discount for SAWC 2020 Virtual Conference

Discounted registration is available for the upcoming SAWC 2020 Virtual Conference. Use the code: FACULTY50 to receive $50 off your registration.

The Symposium on Advanced Wound Care (SAWC) / Wound Healing Society (WHS) virtual conference is July 24-26, 2020. From the comfort of your home access live Q&A, e-Posters, a virtual exhibit hall and the latest updates in wound care research and education.

The multi-track agenda includes the session Team Management of Enteroatmospheric Fistulas July 26th at 3:40 PM EDT. Engage and ask questions from the comfort of your home to gain practical applications and insight on enteric fistula management.

AAST Webinar on Entero-cutaneous and Entero-atmospheric Fistulas

The webinar Entero-cutaneous and entero-atmospheric fistulas: Have we had a paradigm shift in management? is now available online.

Dr. Richard Miller, Chief, Division of Trauma and Surgical Critical Care at Vanderbilt Medical Center presents a comprehensive overview of enteric fistula management and makes a strong case for "feeding the gut".

The webinar is part of the American Association for the Surgery of Trauma Virtual Grand Rounds educational program.

Click here to watch.