The FDA has issued a 510(k) clearance for a new internal fixation system for Charcot foot.
The system, named the G-Beam™ Fusion Beaming System, is manufactured by Orthofix International N.V., a global medical device company focused on musculoskeletal healing products and value-added services.
According to the press release, “Designed primarily for the treatment of Charcot foot, a debilitating condition where the bones in the foot weaken and collapse, the G-Beam devices can be implanted in the medial and lateral columns of the foot to provide alignment, stabilization and fixation.”
“Charcot foot can occur in people who have severe neuropathy (the loss of protective sensation in the limb) or nerve damage which is a common diabetic foot complication.”
“In my practice I often see patients whose uncontrolled diabetes has led to the development of Charcot foot, an extremely disabling condition that if left untreated, can lead to amputation,” said William Grant, M.D., a podiatric surgeon from Virginia Beach, Virginia, who designed the G-Beam system. “Using the G-Beam system allows us to anatomically realign the foot; enabling the bones to heal so these patients can return to a more normal independent lifestyle.”
“The World Health Organization estimates that more than 422 million people suffer from diabetes and that the number will more than double in the next 20 years.”
“When the use of internal fixation is called for, the G-Beam system is designed to fuse the medial and/or lateral columns, as well as bones in the hindfoot, in order to restore a stable foot that may ultimately reduce the probability of an amputation. The system comes with single-use, sterile-packed implants and a compact instrumentation tray.”
Davide Bianchi, president of the Extremity Fixation business unit, said, “The G-Beam Fusion Beaming System is the next step in working towards our objective of becoming a recognized premium solution provider in the Charcot and Diabetic foot market segments This system will allow us to establish ourselves in the internal fixation segment of Charcot treatment options.
Dear Dr. Grant / Mr. Bianchi,
My wife Suzanne has advanced Charcot Foot disease as she has had (controlled with Levimir/Novolog) diabetes for about 18 years with extremely good blood flow to her extremities (5 years of MetaNX) and very good heart and cardiovascular system function. She also has (one remaining) bunion(s), left big toe amputation, right big toe with the supporting bone mostly removed due to recurring MRSA infection in and around the bones in both feet, as well as an amputated left index fingertip (also due to MRSA), and asthma from an intentionally (maliciously set) arson incident some 25 years ago while she was in her home and barely evacuated in time (with smoke inhalation.) We’ve had a very good podiatric surgeon in our area (Corpus Christi, Texas) working with us for the last 3 years but the results appear to be progressing towards amputation(s). We just found the G-Beam article and pictures presented here as we’re looking for a solution for her continuing condition.
I’m currently (temporarily) unemployed so we currently have no insurance but I will soon be re-employed and insured again shortly thereafter. As you may well imagine we’ve amassed quite large medical bills.
Could you please e-mail us information about the G-Beam procedure, where the procedure is (best) implemented/surgically installed, any known complications, etc.
Thank You, Timm and Suzi White
Had a foot reconstruction surgery but keep breaking out on arche area. Heel is pronated up and foot is still needed to be active. Can this g beam be added or redone to correct foot alignment to keep the pressure off center area of foot,?
Do you know any foot surgeons in the Dallas, Rexas area doing this procedure yet.?
I have RA with resultant peripheral neuropathy. Age is 72, no diabetes and do not drink ETOH. I have tarsal tunnel syndrome and worsening Charcots.l live in northern Calif and would be willing to travel anywhere for help and consultation.
Could I get more info on the G-Beam/procedure and find out if I qualify for this surgery.
I have had Charcot joint in my right ankle for about 9 years, I have a ankle deformity and would like to have a normal foot and ankle. My toes are now starting to curl under and I have had a couple of sores but have healed up in time.
Please help me!
Thank you,
Anna Webb