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