FDA OKs Shock-Wave Pain Reliever
Friday, October 13th 2000, 12:00 am
By: News On 6
WASHINGTON (AP) â€” A device that uses shock waves to treat chronic heel pain won Food and Drug Administration approval Thursday.
Often difficult to treat, the chronic heel pain known as plantar fasciitis can be a particular problem for athletes. It is usually caused by an inflammation of the heel tissues.
The FDA said it has approved use of a device called OssaTron, made by HealthTronics of Marietta, Ga., for use in adults who have had the condition for at least six months and who have tried other treatments with little success.
OssaTron uses a spark plug to generate shock waves in a stainless steel chamber filled with water. There is a soft plastic cover over the chamber.
The plastic dome is placed against the heel and the steel chamber focuses the shock waves so they converge at a point within the foot. In a treatment about 1,500 shocks are usually delivered. The treatment is done on an outpatient basis.
The device is a variation of a machine known as a lithotriptor, which uses sound waves to break up kidney stones.
Dr. Argil Wheelock, chief executive of HealthTronics, said the devices could be in use by November, and in many major cities by the end of the year. He noted that physician training in use of the devices is necessary.
Wheelock declined to discuss the cost of treatment, though he said he thought it would be covered by health insurance.
Approval of OssaTron was recommended by an FDA advisory committee in July.
At issue is a sharp pain, aching or stiffness on the bottom of the heel that is at its worst upon getting out of bed each morning. The pain can be caused by bone spurs, but in most cases it is plantar fasciitis, an inflammation of the foot's connective tissue.
Physical therapy, inflammation-reducing pain relievers, cortisone shots and heel-cushioning shoe inserts are typical treatments, but they do not help everyone; severe patients sometimes have surgery.
HealthTronics studied 302 people who had suffered heel pain for six months and failed other treatments. All had anesthesia applied to the foot. Then half had the OssaTron's shock waves beamed into their heels and half had a sham treatment.
Some 60 percent of OssaTron patients reported a reduction in pain compared to 48 percent of sham patients, the FDA reported.
Side effects included nerve irritation or numbness in six patients while two people suffered fascia tears.
Wheelock said the device works by using energy to disrupt scar tissue, causing microscopic damage to that tissue. ``You then get new blood vessel growth into the area, which allows the normal tissue healing cells to come in and repair the injury,'' he said.
On the Net:
Food and Drug Administration: http://www.fda.gov
General heel pain information, http://www.acfas.org/brheelds.html