Could the investors Prospect Venture Partners, Three Arch Partners, and Kearney Venture Partners have rolled the dice on this technology? They call this technique "Precision Lumbar Decompression from the inside out." How precise does the surgeon have to be? What happens if the surgeon doesn't have excellent three dimensional capabilities? I would guess that hand-eye coordination plays an important role in utilizing this system. The question to our readers is, is the IO-Flex System as easy as Baxano claims?
Remember a company by the name of Hydrocision? They were going to change the way things were done with a product called the Spine Jet. Much to everyone's chagrin, they put the cart before they had the horses. No reimbursement code led to resistance by the hospitals, forget about the surgeons that have advocated this technology or are on their payroll. How much could this technology be priced at? $2,500 - $3,500 per procedure. You know what they say in the world of healthcare, "no reimbursement, no interested in using product." TSB wants to know what our readers know?
I was called by a recruiter that was looking to fill a position for them. Base salary $175k and a bonus of $50k if you hit 90 cases in year 1. So they would pay $225k for about $250k of business.
ReplyDeleteNo hospital out there is going to let in a disposable device be brought in for that price on a procedure that if there is no hardware implanted is a money maker.
A standard lumbar decompression necessitates the removal of close to half of a healthy facet joint in order to adequately address lateral recess and foraminal stenosis – causing collateral damage that is often destabilizing and sometimes disabling. An elderly patient with even mild deformity (e.g. spondy, scoli), in need of a simple decompression, typically gets an instrumented fusion because we don’t have the tools to adequately decompress in a targeted, non-destabilizing fashion. It’s about time someone focused on a more effective, less invasive approach to this problem. Baxano’s thin, flexible, guidewire enabled tools may be just the thing to get us there.
ReplyDeleteFlossing my teeth felt a little awkward at first, but after I got used to it, I couldn’t sleep comfortably without it. Is this company’s product an effort to do well by doing good? It’s certainly a unique platform, which you rarely see in this industry, and safety and efficacy look to be the driving forces here. Kudos.
Their booth was slammed 6 deep at NASS, they must have something worthwhile going on. Surgeons told me that they like that the system reaches areas that are very difficult to get to with destabilizing the facet joint. check out the website, they are building a very solid team as well.
ReplyDeleteThe patient you described needs a laminotomy only - no fusion, no dynamic stabilization, no other widgets. Also, removing half of the facet for a decompression is very rarely needed; undercutting the facets out laterally is enough for most patients to obtain an adequate decompression. The historical wide laminectomy, thinning the pars and facet joint does require stabilization. For most, that is a historical procedure.
ReplyDeleteThe problem here is that there is no industry $ to be made off of simple decompressive techniques that work well. Therefore, a market is created whereby "destabilization" requires "stabilization." Any true comparative effectiveness research would sink this fast.
Over-the-wire systems don't require advanced three dimensional capabilities over and above what the surgeon [should] already have. Its a simple, three step techniques that is safe and effective. It's biggest pro is the preservation of the facet's integrity, which is something that no other effective technique can boast.
ReplyDeleteThe research will undoubtedly show the Baxano IOflex as superior and less destabilizing.
What about reimbursement?
ReplyDeleteCosts of direct reps, top heavy with more officers than a bank, reimbursement questions, high payouts, unproven technology...have I seen this all before?
ReplyDelete"The iO-Flex™ system is used in existing fusion and decompression procedures under the applicable hospital and physician codes for those procedures."
ReplyDelete"..undercutting the facets out laterally is enough for most patients to achieve an adequate decompression."
ReplyDeleteDepends on one's definition of "most" and "adequate." Most validated outcome measures of patients after decompression for stenosis show about 75% success...is that "adequate?" probably not if you fall in to the 25% group or subsequently require a fusion because your decompression was too adequate.
I have seen the technology and it clearly addresses a clinical/surgical challenge in a novel manner. The company will need to make the case that value to patient and surgeon can translate to value for payor/hospital.
Apologies for using the word adequate. Would "super" or "fantastic" make us happier. Adequate, in most circumstances, would reflect a decompression that effectively removes stenosis to address the patients symptoms. Seeing as how this is a discussion on new technologies though I should probably use less scientific terms and more marketable nomenclature (that means "awesome" words).
ReplyDeleteFrom standpoint of validated outcomes, 75% success for stenosis is rather low but is probably not too far off. That being said its more likely to be a reflection of difficulties in patient selection than it is in technique. The SPORT data showed between 1 to 4% revision rates for same level recurrent stenosis or instability. Its a hard sell to add so much additional cost upfront for a theoretical benefit especially in a small % of people.
I love how willing we as surgeons are to try something new and assume its going to translate into a clinical improvement. If our instinct is so great, how come all of the recent technological flops to come from surgeon inventors and investors?
Terrible company name...sounds like a detergent.
ReplyDelete"Anonymous said...
ReplyDeleteCosts of direct reps, top heavy with more officers than a bank, reimbursement questions, high payouts, unproven technology...have I seen this all before?
FEBRUARY 8, 2010 5:15 PM"
I doth agree! Kyphon was a bad business case with a happy ending. The early years were totally bass-ackwards and they "lucked out" at the end of things. Hopefully this will have a better business plan behind it
... "existing fusion and decompression procedures under the applicable hospital and physician codes for those procedures".
ReplyDelete-- I see, so it's an additional cost with no additional reimbursement. That'll go over big with the hospitals why?
I got a call from a recruiter about this gig as well, after having scheduled conversations with the "Director of Sales" cancelled, rescheduled, cancelled, call no-showed, call no-showed, I gave up on them. The amazing thing to me is that someone like Recupero with such a sterling reputation, would hire someone like he did to head up sales? I talked with some Kyphon Guys & they just shake their head at this joker as well. BTW, he finally called back & was beside himself that I wasn't interested, it only took him 3 weeks to call me.
ReplyDeleteHad similar experience. The "director" had little spine background and the last time I checked..his name is no longer on Borax..Boxano website. Did get another call regarding their new VP of Sales position. Guess they need more officers.
ReplyDeleteI've seen these guys hudled in corners with KOL's on three continents... I wouldn't underestimate them, also, a simple look at their patents explains the concept pretty clearly - not sure why there is so much confusion.
ReplyDeleteLooks cool to me!
ReplyDeleteThere is not any additional reimbursement, it is simply a very expensive disposable supply. The average hospital Medicare inpatient reimbursement for a non-fusion is $5,383 for MS-DRG 491 (the majority of non-fusions), and $10,017 for MS-DRG 490, with CC/MCC's. The list price for this is over $3K. A hospital cannot add on an additional $3K when they are only getting paid $5K. Yikes! It is a nifty idea that docs seem to love, but what hospital can/ is willing to stomach the additional cost?
ReplyDeleteThey just got another infuse of cash. What do you guys think? Good place to be?
ReplyDeleteGot a call from a recruiter about Baxano sales job. They only have a handful of reps in the U.S. now. My concern (like others I've read on here) is that it's expensive,unproven and has no reimbursement. It seems like a novel idea but why can't you get the same results with a standard kerrison? Sounds like they're copying the Kyphon business model.
ReplyDeleteI have been told by 4 orthopedic surgeons I need a full on L5-S1 laminectomy to relieve pressure on my nerve roots caused by severe stenosis and a congenitally small spinal canal. I am falling, have lower extremity atrophy, no lower extremity reflexes and have been told my back is a "train wreck" and that ambulation is a risk. Cannot walk on my toes or heels. Two surgeons say fusion will not be necessary, two say it will. I am concerned about iotrogenic complications caused principally by instability. Is Baxano for real? The local guy would have to be paid out of pocket as he is does not contract with insurance. Worth it? Thanks
ReplyDeleteCall Dr.Jeffery Baker in Salisbury, NC
Delete"Lower extremity atrophy, no lower extremity reflexes, cannot walk on toes or heels..."
ReplyDeleteHope you've seen a good neurologist to rule out neuromuscular disorders (not spine). I've seen too many patients with ALS, peripheral neuropathy, distal myopathies, etc., hacked on by spine surgeons who got to them first.
id have to agree. make sure you don't have any existing neuropathy before going under the knife.
ReplyDeleteIf you look at the studies and speak with spine surgeons, they believe this gives them the targeted decompression they have been looking for. An arguable, but reasonably understood point I have heard, is that it is technically easier to perform remove the entire facet and fuse than it is to get thorough neuro-foramenal decompression.
ReplyDeleteThe surgeries I have been in are going great, and the patients are experiencing terrific results.
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ReplyDelete