EBI v. Exogen

I guess you are not aware of all the studies currenty being done on PEMF technology. Your ultrasound bone stimulator device may be good for acutre fractures (which heal on their own) but surgeon's get frustrated with using Exogen for more complex non-unions due to failure rate. I do not know too many trauma surgeons using Exogen (unless they are getting paid, of course (through speaking engagements, your "science summits, etc.) Most of the acute fracture Exogen business is with podiatrists who do not bother to cast their patients and who are not confident with their surgical expertise.

 

Spot on.

 

Failure rate?

What is your success rate for non-unions, based on your clinical trials? 60-64%

What is the success rate for Exogen, based on their clinical trials? 86%

The exogen stim has a much higher heal rate for all non-unions, and it has a 20-minute wear time vs. 10 hours per day. What is unfortunate is that Biomet reps are forced to misrepresent their product and lie about things to sell units.

The only recent trial for PEMF was a failed study- an acute fracture study on over 300 patients which showed that PEMF has NO clinical benefit with acute, fixated tibial fractures.

 

Funny. Your Exogen TRUST trial was a bust as well. If you were trying to get an acute, FDA fx indication in today's climate, you would not have approval.

 

Exogen is a nightmare for the patient to use. Cut hole in cast and compromise strength of cast exactly over the spot that needs to be the strongest, fill with gel and place the magic cap in the hole for 20 minutes. Please. Casts begin to stink, soft tissue swells up inside the "window" and if you are not exacatly on the fracture you are not treating anything. Why are they only approved for distal tibia and distal radius? Because those are two of the most subcutaneous areas on the skeleton. Where are the double blind, US based studies on long bone nonunions? They don't exist. How did the study turn out with the use of internal fixation (locked tibial rod)? ZERO success rate. EBI is the gold standard.

 

Hello, I am not an employee of EBI or Exogen but a patient. And I think this entire thread is one of the most hilarious pieces of Net literature I have ever read. The comments are absolutely stellar. I forwarded this to my orthopedic surgeon as well as my internist buddy. I urge anyone with a remote sense of humor to read all of the responses and feel great for the rest of the day. FYI - I am currently 7 weeks out of 3 level ACDF and have been wearing a Biomet Spinal Pak for 12 hours daily. I can't feel anything in particular, with the exception of the electrodes falling off after 12 hours. I've tried both kinds - the one you "moisten" is a joke - forget about moistening anything - neither kind can be reused. I am passionate about recycling, however, and am separating the pads from the electrodes themselves. I will wear this for 3 months and see if there is any fusion going. 58 year old female, thin and in very good shape but bone quality is meh. Also on sermorelin, that seems to help. Thank you for providing me at least 30 minutes of utter fascination - I always knew there was more to reps than just pretty faces, even if "the hooters" are absent on you menfolk. LOL.

 

The EBI marketing pieces referred to as "studies" by what's left of the sales force are a joke. The main one they refer to as the "Pethica Study" was never peer reviewed or published and is their go to selling tool to claim their average days to heal is lower than the competition. The devices are all crap. If you are a spine patient you receive a rebranded "Bioelectron OrthoPak" with it's cords and 24-hour wear time and electrodes that are a nightmare to keep stuck to the skin. The control unit is a plastic piece of junk that must be manufactured in some third world country. They use it for foot and ankle too. The "Bone Healing System" also has cords that run to the part you wear and the thing is such a joke that in their ads they only show the controller and the coil and conveniently leave the cords out of the picture. No thanks, I'll take Exogen every time over either of their antiquated devices. Can't believe insurance companies still pay for these jokes of a product. There are competitive spine units that are much more patient friendly and technologically advanced.

 

Better question is who still pays for these things? Most of the reps with any sales skills at all have abandoned this voodoo and gone on to bigger and better opportunities. Third party billing and national distribution deals have the remaining reps competing for sales in their geography with their own manufacturer and they don't even know it. Why would any physician prescribe a device that needs to be worn for ten or twenty-four hors per day when all of the competitive devices have shorter treatment times and higher success rates? And no electrodes to fall off or cords to wear. G-A-R-B-A-G-E

 

You do realize that one of the largest and most recent Level 1 studies done on bone stims was done on YOUR device, studying acute tibial fractures with locked IM nailing, and it also had ZERO success rate. ( no diff between placebo and active pts)

Exogen- as far as the distal radius and tib, those are ACUTE fracture indications. EBI has NO acute fx indications because there is absolutely no evidence to support acute fx usage. Exogen's trials were done on tib and dist radius to show healing in cortical and cancellous bone, the FDA narrowed the indications to the bones used in the trials. The only indication that your long bone device has is for the treatment of non-unions, which is the exact same for Exogen. Exogen has additional acute fracture indication(s).

As far as studies outside the US: until about 3 years ago it was not a US-based company ( Smith & Nephew is based in the UK).

You are so far off base with the casting that I am not going to even start.

Pea-sized dab of gel, 20-minute session per day.

 

Whoa, the Exogen vs. EBI talk is still alive.

I hear in Boston, MA the TRUST study is going to show some pretty negative data on Fresh Fracture. Will this have any impact on trying to get a fresh fracture covered?

 

Remember when i said many years ago on this message board that EXOGEN WAS A PLACEBO???
Guess what happened with the TRUST STUDY....TERMINATED!