Diabetes is the most frequent cause of non-traumatic lower
limb amputation, with more than 92,000 amputations
performed each year, according to the American Diabetes
Association. Diabetic foot ulcers, suffered by more than
two million diabetics annually, commonly result from
reduced blood flow and can lead to amputation. Direct costs
of a major amputation are estimated to be between $20,000
and $60,000. In contrast, the ArtAssist device can help
people avoid the prospect of disabling amputation and only
rents for $1,200 for a 3-month course of therapy.
"In our clinical study, the ArtAssist device significantly
increased blood flow and saved limbs in 70 percent of the
patients studied," said Dr. Paul S. van Bemmelen, vascular
surgeon at Stony Brook University Hospital, New York
. "We must get the word out now to help prevent amputation
in as many people as possible."
By increasing blood flow, the ArtAssist device also
relieves symptoms of peripheral arterial disease, also
known as "hardening of the arteries," which affects more
than four million Americans each year, the majority of whom
are over the age of 55. Symptoms, called intermittent
claudication
, include pain, cramps or a tired-feeling in the calf or
thigh, triggered by walking and relieved by rest. This
prevents the ability to walk and greatly reduces the
quality of life. Clinical studies have shown that the
ArtAssist device triples blood flow and dramatically
increases pain-free walking distance.
The ArtAssist device applies a massage-like compression to
enhance blood flow and simulates the beneficial effect of
brisk walking, without pain or tissue trauma. Patients
simply turn the device on after applying the specially
designed limb cuffs. The standard therapy calls for
patients to use the ArtAssist device for three hours a day
in one-hour segments and beneficial results appear within
days to weeks, with more permanent results achieved in
three to five months.
Poor blood flow from diabetes had already cost Frank
Berhalter of Long Island his right leg. But by using the
ArtAssist device to improve his circulation, Berhalter has
been able to keep his other leg and enjoy an independent
lifestyle.
"I started using the ArtAssist device for a diabetic foot
ulcer that was not healing," said Berhalter. "This was the
same symptom that led to the amputation of my right leg and
so I was very concerned. The ArtAssist device was simple to
use and after three months, my ulcer was completely healed.
I credit ArtAssist for saving my leg."
Currently not covered by Medicare/Medicaid, ACI Medical is
in the process of obtaining an individual Medicare/Medicaid
code for the ArtAssist device. Many private insurance
carriers cover the device as Durable Medical Equipment
.
"We originally developed this technology to assist in
imaging vessels in the foot," said Ed Arkans, president of
ACI Medical. "After testing the device in a hospital
setting, we were surprised to see a large increase in
arterial blood
flow and the immediate alleviation of pain in a patient
with severe arterial disease. We then decided to develop a
product based on this technology to hopefully save patients
the trauma of amputation."
About ACI Medical
Headquartered in San Marcos, ACI Medical designs and
manufactures products for vascular disease. More than 25
clinical studies by vascular surgeons at university-based
hospitals have been published or presented at medical
conferences, and confirm that use of the ArtAssist device
has significant effect on improving blood flow in patients
unable to undergo surgery and has the potential to reduce
the need for amputation by more than 50 percent. Abstracts
and further information are available on the ACI Medical