Off Loading Devices For Ulcers

Sundance Enterprises, Inc.

Website:
www.sundancesolutions.com
Phone number:
877-560-9871
Email:
info@sundancesolutions.com
Location:
White Plains, NY
Founded:
1992

1) Specific types of product lines that you make? 

Fluidized Positioners, Fluidized Heel Protection Systems, Specialty Foam & Fluidized Mattresses.

2) Provide a brief description of your company.
Sundance is committed to the development of clinically effective, innovative and affordable medical products. All of our products are developed with a focus on the unmet needs of the caregiver and patient. Sundance improves the value of each product by adding clinical options such as fluidization that can be customized throughout all product lines based on individual patient needs. The goal is to reduce costs while maintaining or improving clinical outcomes.

3) Is there a specific type of ulcer that your product’s use is most effective for in its application?
Offloading of all areas of the body that are at risk for breakdown.

4) Is the product reimbursable?
No

5) What is the rationale for the use of your product (how does it provide adequate offloading … ie how does it work?)
Z-Flo Fluidized Positioners are designed to promote and maintain neutral body alignment while effectively off-loading and supporting bony prominences. Z-Flo technology redistributes pressure, and reduces friction and shear.

6) How frequently should the product be removed and subsequently re-applied?
Use of Z-Flo positioners enables caregivers to effectively maintain turning protocol. Positioning changes can be made w/o removing the product and with minimal disturbance to the patient.

7) Should patients remove the device?
No

8) Is there a way to monitor proper use of the product?
All staff will be in-serviced on the correct uses of Z-Flo and Heel protection Products. Training videos are also supplied.

9) What is the device made of?
Medical Grade urethane, Fluidized micro-spheres

10) Are there any contraindications to its use?
NO

11) Why should providers recommend or prescribe the use of the product versus other methods?
Z-Flo addresses effective turning and repositioning of patients simultaneous with addressing skin concerns. It addresses, in a single product, a multitude of caregiver issues that are traditionally addressed with multiple products. By making every mattress more effective and providing the caregiver with variable patient care solutions, our products will improve clinical outcomes in all care settings while dramatically reducing the cost associated with that care.

Lavin Lift Strap (div. of Lavin Inc.)

Website:
www.lavinlift.com
Phone number:
(888) 545-5438
Email:
inquiries@lavinlift.com
Location:
 Ann Arbor, MI
Founded:
2000

1) Specific types of product lines that you make? 

Lavin Lift Straps and Lavin Lift Strap Adapters

2) Provide a brief description of your company.
The Lavin Lift Strap product and process allows one caregiver to safely change and clean both incontinent bedridden patients and patients with wounds. Caregivers no longer turn and lift their patients to clean and treat, thus avoiding injuries. Patients are changed more often, avoiding pressure ulcers and skin breakdown.
In instances where limb suspension (offloading) is recommended or required in order to treat injuries such as pressure ulcers or diabetic ulcers, the Lavin Lift Strap provides a secure suspension allowing the caregiver to treat these without having to hold up the limb or have another caregiver assist in the process.

3) Is there a specific type of ulcer that your product’s use is most effective for in its application?
There would be no specific type of ulcer where the Lavin Lift Strap is most effective. There are specific instances where the Lavin Lift Strap would be most effective in its application. In instances where limb suspension (offloading) is recommended or required, in order for a caregiver to treat a wound or pressure ulcer. The Lavin Lift Strap when used with a patient lift allow the patient lift to do the lifting when suspending a limb while treating wounds such as pressure ulcers or diabetic ulcers. The caregiver would then be able to concentrate on treatment, and not be required to perform two tasks at once, (lifting and treatment), or require another person to lift the limb during treatment. See video for limb suspension in website www.lavinlift.com

4) Is the product reimbursable?
The Lavin Lift Strap is Medicare approved under Slings E-0621.

5) What is the rationale for the use of your product (how does it provide adequate offloading … ie how does it work?)
In instances during treatment of wounds where suspension of the limb is required to access wound areas, typically, one caregiver will simultaneously hold the limb and treat the wound, or require a 2nd caregiver to suspend the limb while he or she is actually treating the wound. The Lavin Lift Strap, used in conjunction with any patient lift will securely suspend the patient’s limb allowing one caregiver to concentrate on wound treatment. See www.lavinlift.com limb suspension video.

6) How frequently should the product be removed and subsequently re-applied?
The Lavin Lift Strap, in offloading instances, should only be used during wound/pressure ulcer treatment by the caregiver not by the patient.

7) Should patients remove the device?
Since the Lavin Lift Strap is to be used only during treatment, the caregiver will be the only person applying or removing the device.

8) Is there a way to monitor proper use of the product?
Lavin Lift Straps should only be used during treatment when the caregiver is present. Patients are not to be left unattended.

9) What is the device made of?
Lavin Lift Straps (with a tensile strength of four hundred pounds per strap) are composed of a dense nylon material over foam padding for comfort with fastener straps made of webbing.

10) Are there any contraindications to its use?
The Lavin Lift Strap is not designed to offload or suspend a patient for extended periods of time but utilized as prescribed for treatment and monitored. It is meant to be used by a caregiver during actual wound/pressure ulcer treatment, making the task of wound/pressure ulcer treatment easier. It is not to be used to restrain or transport patients. It is not the intent of Lavin Inc to provide medical advice but rather to inform medical professionals and other caregivers about the proper use. Medical professionals should always be consulted with questions as to whether any lifting method is medically appropriate.

11) What are the price points of your product:
Please contact Lavin Lift Strap for purchasing information.

12) Why should providers recommend or prescribe the use of the product versus other methods?
In instances where caregivers are required to hold up limbs/lower body during treatment of wounds/pressure ulcers, the Lavin Lift Strap along with any patient lift, will do the actual lifting, securely suspending the patient limb/s allowing one caregiver to do the actual treatment versus traditional methods in employment. For additional information please reference the poster, “Evaluation of new lifting product to promote patient hygiene, reduce risk of pressure ulcers and reduce caregiver’s repetitive stress injuries” by Mary Webb RN, submitted and presented at the 2010 S2 Symposium on Advanced Wound Healing Society Meeting and at the 2010 Joint Annual Wound Ostomy Continence Nursing and World Council of Enterstomal Therapist Conference. This poster can be accessed on www.Lavinlift.com or at the conference websites.

Darco International, Inc.

Website:
www.darcointernational.com
Phone number:
(800) 999-8866
Email:
jauvil@darcointernational.com
Location:
 Huntington, WV
Founded:
1985

1) Specific types of product lines that you make? 

Post Operative footwear and wound care-offloading products.

2) Provide a brief description of your company.
Darco is a world leader in the manufacture and distribution of postoperative footwear, wound care-offloading products, walking boots and night splint products. Established in 1985, Darco prides itself on being a provider of quality, innovative products used by the medical community worldwide. Our Square Toe Medical Surgical Shoe is the most popular postoperative shoe in the USA. We welcome all inquiries regarding our products, and invite you to visit our web site to view our products and to request samples or literature.

3) Is there a specific type of ulcer that your product’s use is most effective for in its application?
Darco products are focused on effectively offloading wounds and ulcers of the feet.

4) Is the product reimbursable?
In some cases, yes.

5) What is the rationale for the use of your product (how does it provide adequate offloading … ie how does it work?)
Darco Offloading products are the first line of defense and are easily modified to relieve pressure and offload the wound site. Our shoe insoles are made of medical grade EVA, they can be removed to modify and offload quickly and easily. Our Peg Assist Offloading Insole is an excellent compliment to our shoes and provides maximum pressure relief.

6) How frequently should the product be removed and subsequently re-applied?
Depends on the size, location of the wound and patients mobility.

7) Should patients remove the device?
They can if needed or desired

8) Is there a way to monitor proper use of the product?
Patient must communicate with the doctor and remain compliant

9) What is the device made of?
Various medical grade materials.

10) Are there any contraindications to its use?
n/a

11) What are the price points of your product:
The price point can vary. Doctors purchase our products and dispense to patients. Patients can purchase our products through a DME or other suppliers. 


12) Why should providers recommend or prescribe the use of the product versus other methods?
Offloading is the key to healing a wound or ulceration. Pressure reduction must happen first and foremost. The best creams, dressings in the world will not work to heal the wound if there is still direct pressure to the site. Offloading must take place to eliminate pressure.

DM Systems, Inc.

Website:
www.heelift.com
www.dmsystems.com
Phone number:
(800) 254-5438
(847) 328-9540
Email:
 info@dmsystems.com
Location:
 Evanston, IL
Founded:
1979
1) Specific types of product lines that you make? 

Heelift Suspension Boot
Heelift AFO

2) Provide a brief description of your company.
DM Systems Inc, makers of the Heelift Suspension Boot and the new Heelift AFO, has been providing quality health care solutions for over 30 years. . Developed by orthopedic surgeons, our product lineup consists of wound care, casting, rehab and orthotic solutions designed and manufactured to treat ailments that range from ankle sprains and shoulder subluxations to heel pressure ulcers. Our team of forward-thinking clinicians anticipates patient needs to create innovative solutions that bring quality patient care and comfort to a cost-conscious medical marketplace.

3) Is there a specific type of ulcer that your product’s use is most effective for in its application?
Heel pressure ulcers

4) Is the product reimbursable?
When prescribed for foot drop or plantar fasciitis, the Heelift AFO is fully reimbursable under code L4396; Heelift Standard is only partially reimbursable for treatment under code E0191.

5) What is the rationale for the use of your product (how does it provide adequate offloading … ie how does it work?)
All of the Heelift brand products use a fixed elevation pad to float the heel in a protective space. A spare pad can be used to provide additional elevation and customization.

6) How frequently should the product be removed and subsequently re-applied?
The boot should be removed to check the skin daily.

7) Should patients remove the device?
Patients can remove and re-apply the Heelift quickly and easily.

8) Is there a way to monitor proper use of the product?
The hole at the bottom makes visualization and palpation of the heel easy.

9) What is the device made of?
The Heelift is made of a soft foam with a tricot stiffener. The Heelift AFO has a soft foam interior and a semi-rigid polypropylene brace.

10) Are there any contraindications to its use?
n/a

11) What are the price points of your product:
a) provider
List Price: Heelift Standard $35.20 Heelift AFO $99.95
b) facility
Broadlane(MedAssets), Novation, Kaiser and Premier facilities should call for special pricing
c) and patient?
See list price.

12) Why should providers recommend or prescribe the use of the product versus other methods?
The Heelift and Heelift AFO are as effective as more expensive products, while maintaining excellent results. The Heelift has been used by thousands of facilities throughout the world, and has been providing quality prevention and treatment of heel pressure ulcers for over 30 years.

Milsport Medical Products, LLC

Website:
 www.milsportmedical.com
Phone number:
(877)341-6494
Email:
 info@milsportmedical.com
Location:
 Buffalo, NY
Founded:
2009
1) Specific types of product lines that you make? 

Focus on Wound, Geriatric, Bedsore, and Diabetic products.

2) Provide a brief description of your company.
Milsport is a group of industry professionals brought together through a common vision. That vision is to change the face of the medical industry and the medical devices used to heal and prevent medical conditions, while keeping patient comfort at the forefront of our thought process.
Milsport is a group of innovative thinkers working closely with medical professionals and doctors to address issues from a fresh perspective. Aligning ourselves with a cutting edge preventative thought process. Milsport's focus is on creating dual use customizable products for prevention as well as treatment.
In this time of medical reform, Milsport's posture is consistent with the common goal to reduce health care costs, by reducing occurrences, and healing time.

3) Is there a specific type of ulcer that your product’s use is most effective for in its application?
Pressure ulcers of the heel, toe, and ball of foot.

4) Is the product reimbursable?
Yes.

5) What is the rationale for the use of your product (how does it provide adequate offloading … ie how does it work?)
The Heel Rest is equipped with an ergonomic calf pad that lifts the heel up and suspends it in open heel cavity, which allows free airflow to the effected area.
Offloading of the toes and ball of the foot can be achieved by lowering the flip back toe design to insure that no contact is made with the ulcer.
The Air-0-tech low friction liner and strapping fabric allows for free air-flow on the skins surface, and insures against moisture build up that can cause maceration and further instances of ulceration.
The Heel Rest is also completely launderable and reusable and is treated with nano-silver anti-bacterial/anti-microbial treatment that kills harmful bacteria that can cause odor.

6) How frequently should the product be removed and subsequently re-applied?
It is suggested that the Heel Rest be removed and reapplied every 8-13 hours to inspect the foot, ankle, and lower leg.

7) Should patients remove the device?
It is easy to use and adjust. The clinician will in most cases provide the initial fitting, but the product can be adjusted, removed, and refitted by the patient without a problem.

8) Is there a way to monitor proper use of the product?
Insure that the heel is placed properly in the device so that it remains in the open cavity and is completely suspended. Lower leg fastening straps should be tight enough to keep the device on, but loose enough to insure good circulation to the lower leg and foot.

9) What is the device made of?
The core of the device is made of ergonomically shaped open cell foam pads, the liner and strapping is made of our proprietary low friction fabric called Air-0-Tech, and the outside of the is made of a cotton twill to insure proper foot stabilization on linens.

10) Are there any contraindications to its use?
We have found no contraindications to the use of this product.

11) What are the price points of your product:
Please contact Milsport Medical Products, LLC or your local sales representative for pricing.
Accessories:

Questions and Answers for Elbow Rest
3) Is there a specific type of ulcer that your product’s use is most effective for in its application?
Pressure ulcers of the elbow area. Also indicated for offloading pressure of sensitive elbows due to bursitis, post op, RA, gout, and ulnar nerve compression.

4) Is the product reimbursable?
Yes

5) What is the rationale for the use of your product (how does it provide adequate offloading … ie how does it work?)
The Elbow Rest utilizes a patent pending pad system that eliminates elbow pressure by total suspension of the elbow for treatment and prevention of ulcers and pressure sores. This unique customizable pad system allows the user to place the pads around ulcer or sensitive areas, including the ulnar nerve. Pads can be rotated frequently for new positioning.
The customizable pads are made from a soft dual density breathable core that allows moisture to move away from the skin to help prevent further skin breakdown. Silver anti-microbial treated pad fabric and linerfabric kills harmful bacteria that can cause odor.
The Elbow Rest is also equipped with an open cavity design that insures free air movement to the effected area while insure that the ulcer does not make contact with external surfaces.

6) How frequently should the product be removed and subsequently re-applied?
It is suggested that the Heel Rest be removed and reapplied every 8-13 hours to inspect the effected area and proper circulation.

7) Should patients remove the device?
It is easy to use and adjust. The clinician will in most cases provide the initial fitting, but the product can be adjusted, removed, and refitted by the patient without a problem.

8) Is there a way to monitor proper use of the product?
Insure that the elbow is placed properly in the device so that it remains in the open cavity and is completely suspended and is not making contact with the movable pad system. Fastening straps should be tight enough to keep the device on, but loose enough to insure good circulation to the lower leg and foot.

9) What is the device made of?
The core of the device and the pad system is composed of dual density, breathable open cell foam, the liner and strapping is made of our proprietary low friction fabric Air-0-Tech, and the outside of the is made of a cotton twill to insure proper foot stabilization on linens.

10) Are there any contraindications to its use?
We have found no contraindications to the use of this product. 


11) What are the price points of your product:
Please contact Milsport Medical Products, LLC or your local sales representative for pricing.