What is Fist Assist?

A novel, non invasive external medical device which uses a pneumatic balloon for intermittent fistula compression.

DEVICE CONCEPT

A NON-INVASIVE, COST-EFFECTIVE METHOD TO MATURE FISTULAS AND HELP TAKE SIGNIFICANT COSTS OUT OF THE SYSTEM

There is a global need to provide better vein dilation methods and devices to sufficiently dilate a vein for hemodialysis, help mature fistulae, and help ensure that AVF reach their optimal size without extra delay and extra procedures.

The Fist Assist® device (US Patent 8231558) is an external medical intermittent pneumatic compression device that can apply intermittent pressure to a specific arm vein that may help dilate the vein after fistula placement.

Our Mission:

Develop a novel, non-invasive, low cost device to:

  • assist with Fistula Maturation
  • assist with Venous Pre-surgery preparation
  • decrease total catheter contact time and fistula development time
  • significantly reduce costs in treating Stage 4 and ESRD markets
NEWS

Fist Assist to present exciting new research and data. Look for us!

“A further interesting technology featured in the CX Innovation Showcase was the Fist Assist device which is a novel, non-invasive, low-cost device developed to assist with fistula dilation, venous pre-surgery preparation and to decrease total catheter contact time and fistula development time. According to presenter Tej Singh (Los Altos Hills, USA), initial patient compliance with the device has been favourable and a large pre-fistula surgery study is planned.”

CX Innovation Showcase
London, April 27th, 2017

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“No patients [of FistAssist] experienced thrombosis or adverse effects. Patient compliance and satisfaction was high. After 1 month, the mean percentage increase in vein diameter in the FA treatment group was significantly larger (p=0.05 than controls in the first 5 mm segment of the fistula. Even more impressive was the early rapid enlargement of forearm fistulas compared to upper arm at all segments (p<.05) at one month. All fistulae treated with FA are still functional with no adverse outcomes.”

Medical Device News Magazine
Florida, June 2017

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RESEARCH
  • In 2012, ESRD patients made up less than 1% of the CMS patents but accounted for approximately 6% of the budget or $34.3 billion annually.

  • Hemodialysis treatment costs an average of $89,000 per patient annually in the United States, a total annual cost of $42 billion annually (significant portion is maturation and catheter issues).

  • Early application of external intermittent pneumatic compression assists in AVF fistula dilation.

  • External devices may have an important role in cost effective fistula maturation and clinical outcomes.

Many patients in the world suffer from renal failure from common underlying conditions including hypertension and diabetes. Renal failure affects about 20 million people in the United States alone and many will progress to end stage renal disease (ESRD). Over 400,000 patients in the United States receive hemodialysis treatment for ESRD and an additional 100,000 patients are expected to be added to this number annually. Numbers globally are also increasing at an alarming rate due to the diabetes epidemic.

Dialysis options include temporary central catheter, peritoneal dialysis and hemodialysis via autogenous arteriovenous fistulas (AVF) or prosthetic grafts when veins are small. Many patients and healthcare providers prefer hemodialysis via arm veins as the best hemodialysis option based on patency, durability and cost effective option.

AVF is the preferred method of vascular access, but unfortunately many veins are not useable do to size or quality. Successful AVF maturation requires high blood flow, wall thickening and vein dilation in order to accommodate repetitive needle cannulation and long term patency. Many studies have concluded that it is hard to predict which veins will enlarge to the appropriate size for dialysis use even after preoperative vein mapping studies. Unfortunately, many arm veins fail to dilate and enlarge enough after subjecting them to arterial flow to allow for dialysis to occur. This results in more central vein wall catheter contact time and infection, patient/provider inconvenience, more procedures, frequent readmissions, delayed care and increased cost to our society caring for renal failure.

After successful AVF surgery, patients over the years have been instructed to apply intermittent upper arm rubber bands, do hand exercises like squeezing rubber soft devices, and arm exercises like resistive weight training. These exercises have shown some benefit in vein dilation and possible fistula maturation but patient compliance has been low.

Extensive research has shown that intermittent compression, handgrip training, external heat application and topical agents like nitric oxide help dilate superficial veins. It is also well known that large preoperative veins tend to develop and mature faster after AVF surgery. It is well accepted that an AVF failing to dilate and mature after 6 weeks, will be evaluated by ultrasound and possible interventional evaluation to assist in dilation and maturation.

SHOWN ACROSS THE WORLD
MARKET POTENTIAL
  • 1 in 10 adults have some form of Chronic Kidney Disease
  • Global ESRD continues to increase – 4.5 MM patients by 2020
  • 100K new patients yearly start hemodialysis
  • 45% of patient growth will be driven by China, Brazil, India, and other emerging markets
  • By 2020 these markets will account for 33% of the dialysis populations
FIST ASSIST: SAFE & EFFECTIVE

CLINICAL TRIALS

MS Ramaiah Medical College, Bangalore, India

Delays in AV fistula (AVF) maturation can cause care delays and increased costs. Increased distention pressure and intermittent wall shear stress may dilate veins based on prior research. Early use of non-invasive devices may help assist clinical AVF dilation.

This was an IRB approved study. After AVF creation, a novel, intermittent pneumatic compression device [Fist Assist® (FA)] was applied 15 cm proximal to AVF to apply cyclic compression of 60 mm Hg for six hours daily for 30 days. Among the patients who completed one month follow up, thirty (n=30) AVF patients were in the study arm to test vein dilation with FA. Controls (n=16) used a sham device. Vein size was measured and recorded at baseline and after 30 days by duplex measurement. Clinical results (percentage increase) were recorded and tested for significance.

No patients experienced thrombosis or adverse effects. Patient compliance and satisfaction was high. After one month, the mean percentage increase in vein diameter in the FA treatment group was significantly larger (p=0.05) than controls in the first 5 mm segment of the fistula after the anastomosis. All fistulas treated with FA are still functional with no reported thrombosis or extravasations.

Early application of an intermittent pneumatic compression device may assist in AVF dilation and are safe. Non-invasive devices like Fist Assist® may have clinical utility to help fistulae development and decrease costs as they may eventually assist maturation. Further studies directed to maturation are required.

Patient Results

  • Adverse effects
  • Thrombosis rate
  • Device failure
  • Arterial Occlusion

= 0

COMPARED TO TYPICAL OUTCOMES

70%

thrombose or require corrective procedure to maintain or restore blood flow within 1 year of initial surgery (primary unassisted patency loss)

1.J Surg Res 2011

65%

1.RCFs not used for hemodialysis (Suitability Failure)

JAMA 2008

44%

unassisted AVF maturation rate

1.NIH, ASN 2016.

 

22%

assisted AVF maturation rate

1.NIH, ASN 2016.

 

34%

maturation failure rate

1.NIH, ASN 2016.

 

PLAYOFF OR PAYOFF OPPORTUNITY BRACKET
THE NEW FISTULA PARTNERSHIP AND PATHWAY

COST EFFECTIVE, SAFE, PATIENT DIRECTED PROCESS

IP STATUS

United States Patent

Patent No.: US 8231558 B2

Date of Patent: Jul. 31, 2012

IP protected through July 2032

Clinical data ongoing

Patented Technology Includes:

  • External arm fistula dilation
  • External pneumatic compression
  • Trackball compression
  • Technological and method patent

CONTACT US

Tej M. Singh, MD, MBA
CEO, President
Fist Assist Devices, LLC
fistassistdevices@gmail.com
(650) 444-2599