Tag Archives: bioness

Walk-testing the New Bioness L300 Go

I’ve been using a Bioness L300 for just over five years to counter my foot drop. Without the L300 strapped to my left leg, it’s difficult for me to walk more than 25 or 30 steps, even with two canes.

The L300 is a functional electronic stimulator (FES). Each time I start to lift my left leg to walk, it sends a low-intensity electrical pulse down a nerve that runs from my knee to my ankle. That pulse forces my foot to flex upward from my ankle so that my toes don’t drag. The electrical pulse replaces the signal that my brain should be sending to the nerve that my MS has blocked, and it counters my foot drop.

About six months ago, L300 manufacturer Bioness received the OK from the U.S. Food and Drug Administration to market a new model of the L300, the L300 Go. A few days ago, I had an opportunity to “test-walk” the Go, and here’s what I found.

No foot sensor neededL300 Go

The biggest and best difference is that the L300 Go doesn’t require you to use a foot sensor in the heel of your shoe. In the original L300, the sensor is used to detect your motion as you begin to walk. It sends a Bluetooth-like signal to the cuff on your leg, telling it that you’re trying to move. The cuff then generates the pulse that stimulates the nerve in your leg and helps you to lift your foot.

That means that anytime you change shoes, you need to move the sensor to the pair that you’re going to wear. Not only is that a nuisance, there can be a lack of consistency in where you place the sensor in the shoe. Also, because insoles are different, there can be the same inconsistency in the amount of heel pressure that’s required to trigger and to end the pulse.

Naturally, you can’t use the original L300 if you’re barefoot.

3-D motion detection

Without a foot sensor, the L300 Go’s cuff detects the start of your leg motion. This is similar to the process used by the WalkAide, a competitor of the L300. Unlike the WalkAide, the L300 Go has a 3-D-motion-detection system. Not only does it detect the forward and backward motion of your leg, it also detects sideways movement and leg rotation. This allows a physical therapist to adjust the unit more precisely to make it more responsive to each patient’s unique gait. To provide this three-way detection the Go contains four electrodes, compared with the original unit’s two.

No control unit

The original L300 requires you to carry a small control unit, which you use to turn the device on and off, put it into “test mode,” and also to adjust the intensity of its pulse. With the Go, this is all done on the side of the cuff. (If you really want a foot sensor or a control unit, Bioness will sell you one. But why would you want one?)

The test walk

The Go looks and feels like the original L300. Maybe I walked a little faster with it. Maybe it triggered a little quicker. I don’t think that it allowed me to walk any further than normal. On the other hand, it was certainly nice to be able to sit in a chair without having to turn off the unit so that it wouldn’t trigger when I released the pressure on a heel sensor. Unfortunately, I forgot to test the Go walking up and down stairs. My guess, however, is that it would work better than the original unit because its trigger mechanism isn’t dependent upon heel pressure.

What’s it going to cost?

The Bioness rep told me that the Go will cost the same as the current L300. That’s about $6,200. I was also told that there would be a discount if current users wanted to upgrade, but she couldn’t say how much it would be.

Don’t count on insurance picking up the cost. Bioness apparently has had greater success recently getting insurance to pay for the L300 than when I got mine in the fall of 2012. But, it’s a fight and a lot of really good documentation is necessary. The same goes for Medicare and Medicaid. Again, don’t hold your breath waiting.

Do I plan to upgrade?

Nope, not at that price. Even with a discount, the benefit that I’d receive probably wouldn’t be enough to justify the cost of the upgrade, at least not now.

Bioness tells me that it intends to support the original L300 units for “at least the next three years.” So, I guess if my unit breaks down in 2020 or later, I may have to go for the Go.

If the L300 Go is right for you, however, Bioness expects to begin shipping it in October to patients whose doctors have given them a written order.

(This post first appeared as one of my columns on www.multiplesclerosisnewstoday.com).

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Some FAQs about the Bioness “L300 Go”

(This is a sightly updated version of a column of mine that first appeared on http://www.multiplesclerosisnewstoday.com)

Earlier this year Bioness announced that the U.S. Food and Drug Administration had cleared its new “L300 Go” functional electronic stimulator (FES). It’s an upgrade of the original “L300” that I’ve been using for more than five years. Without the “L300” strapped to my left leg it’s difficult for me to walk more than 25 or 30 steps, even with two canes.

The “L300” sends a low-intensity electrical pulse down a nerve that runs from my knee to my ankle each time I begin trying to lift my left leg to walk. That pulse forces my foot to flex upward from my ankle, so my toes don’t drag. (What the docs call “foot drop“). The electrical pulse replaces the signal from my brain to my ankle that’s blocked by my MS.

When Bioness recently announced the FDA clearance of the “L300 Go” a news article was published on the Multiple Sclerosis News Today web site. That story generated several questions from readers, who wanted a better understanding of the “L300 Go” and how it’s different from the “L300.” So, I’ve been in touch with the folks at Bioness and will try to answer some of the questions that I’ve seen posted.

What’s the difference between the “L300” and the “L300 Go?”

As I understand it, the “L300 Go” allows a therapist to use 3-D motion detection system to better adjust an “L300” to make it more responsive to a person’s gait. The 3-D motion detection seems to be the most important new feature. This motion detection system also allows “L300 Go” to be used without the sensor that the “L300” requires to be placed your shoe.  That means you’re able to change shoes without having to move a sensor, and even use the device barefoot! (A competitive device, called the “WalkAide,” has had this feature since it came on the market around the same time as the “L300”). The “L300 Go”also responds to motion somewhat faster than the “L300.”

I’ve been using the L300. Does FDA clearance mean that Medicare and insurance will now pay for it?

The FDA clearance was for a new product, the “L300 Go.” The “L300” was cleared by the FDA in the U.S., and received European Commission approval several years ago. The recent clearance doesn’t change the fact that, though Medicare has approved the L300 for use by spinal cord injury patients, and at least one nervous system disease, Medicare has never approved the “L300” for use by MS patients. As we all know, insurance companies aren’t likely to approve something that Medicare hasn’t approved.

Will Medicare pay for the “L300” for MS patients in the future?

A spokesperson for Bioness tells me that “veterans and their families already have access to our technology as a covered benefit through the Veteran’s Administration. We continue to work with the Centers for Medicare & Medicaid Services (CMS), as well as private/commercial insurance companies, to expand coverage criteria to include more of their beneficiaries.”

Will the price of the “L300” drop now?

I doubt it. I haven’t seen what the price will be for the “L300 Go,” (if that’s even been determined), but Bioness has said it will give a price break to current “L300” users who want to “upgrade.”

Why do you say the FDA “cleared” the “L300 Go,” rather than “approved” it?

It’s a technicality. The FDA “approves” new drugs but it “clears” the use of new medical equipment. Don’t ask me why.

 

“Bracing” Yourself for MS

(This post first appeared as one of my columns on http://www.multiplesclerosisnewstoday.com)

One of the MS blogs that I follow is written by Jen, who lives in England.  It’s called Tripping Through Treacle.  (Treacle is a thick, molassas-like, syrup). Doesn’t that neatly sum up the lives of many of us in just three, alliterative, words?  From MS newbies to old timers like me, we worry (or have worried) about tripping.  Many of us try to do something about that, however, and one of the options is to wear a brace.

AFOs

The formal name for these uncomfortable looking things is Ankle-Foot Orthosis, or AFOs.  Jamie, who writes the Multiple Experiences blog, is trying an AFO right now to help with her foot drop, which is what trips up many of us.  Well, she’s sort of using one. Jamie has told her blog followers that she “hates” the brace.  She finds it inconvenient to use, especially because you need to take off your shoe, slip the AFO into that shoe strap it onto your shin, and put your shoe back on when you want to walk with it.  This can be particularly cumbersome if you need it on your right leg, the leg that you use when you’re driving.  Jamie says she’d rather use her walker but she plans to give the AFO another try in a couple of weeks with help from a physical therapist.

Working with a PT or, better yet, an orthotist is important.  An orthotist is a specialist in making and fitting orthosis.  After getting a prescription the orthotist will measure your leg and foot and the AFO is then custom-made from those measurements.  Then the orthotist fits, tests and adjusts it before sending you back out into the world to walk with it.

afos

Cheryl’s AFO collection

An AFO is typically made from metal or plastic but some are made of strong, but lightweight, carbon fiber.  Cheryl Hille, an MS patient who runs marathons and about whom I wrote several weeks ago, has half a dozen custom-made AFOs to use in various situations.  I used an AFO a few years ago for a short period of time, (though I wasn’t running any marathons), until I “upgraded” to a Bioness L300 device.

FES Units

The Bioness L300 uses a cuff that straps to your leg under the knee cap.  A pad in the heal of your shoe senses when you begin to try to raise your foot.  It then sends a programmed, l300low-level electrical stimulation that activate the nerves and muscles that raise your toes and lift the foot. (The process is known as Functional Electrical Stimulation, or FES). You’ll need a prescription for the L300 and a Bioness approved therapist will need to fit you and adjust the unit.

I’ve used an L300 for about five years.  At first, it worked so well that I was able to walk a city block without tiring, something that I hadn’t been able to do previously.  With my cane I even walked up a grass covered hill, which was amazing.  Alas, I don’t walk as well, over all, as I did five years ago and I’m now using two canes.  I can’t do that hill anymore but without the Bioness strapped to my leg I wouldn’t be able to walk more than about 50 feet. I really depend upon it. The L300 can also be put into a “test” mode, which will trigger the stimulus while you’re sitting in a chair, so that you can exercise that leg muscle even when you’re not walking.

A similar unit is made by WalkAide.  Unlike the Bioness unit’s sensor the WalkAide cuff, itself, senses your movement, so you don’t have to wear a shoe.  I tried a WalkAide, briefly, when I was trying the L300 but I didn’t feel as stable with it as I did with the Bioness unit.  Remember, both with AFOs and these FES units, each MS patient is probably going to have a different user experience.  I’d recommend taking each device for a test walk, or two, before you buy.

Naturally, none of these devices are inexpensive.  I think my custom-made carbon AFO cost about $800, which included the services of the orthotist.  The L300 was selling for about $5,000 five or six years ago, but I was able to get a slightly used one for around $3,000.  Insurance covered most of my AFO but it didn’t cover any of my FES.  (That’s a rant for a future column).

If you’d like more information about all kinds of mobility devices, checkout the (U.S.) National MS Society’s web site.