Future?

How far do you think these guys will get trying to ride intuitive's coat tails?

 

have a look at the message board at Mako, they are all delirious and speak of the final answer in joint arthroplasty. They refuse to understand that its a UNI implant . As for the hip, there is more to reaming an acetabulum for a successful hip...
Look at the Mako mgt and board. GE people who dont know anything about implant design etc.
This stock does well and they don't make money ? A day of reckoning will come.

 

I hear the FDA is investigating their methods of lying to admin when selling their robots.... Just a matter of time...

 

I sell the robots, please explain to me where these lies are occurring?

 

I also heard they are violating some sort of FDA deal about how they are selling the robots.

 

Is the halo effect real? Mako sure markets that it is.

 

I just signed up as one of their MPS reps. What a bunch of liars!!! I'm already back looking again. This place is a disaster

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2303276

Lot Number DOC
Event Date 11/09/2009
Event Type Injury Patient Outcome Hospitalization; Required Intervention Disability Other
Event Description
Implantation of unicompartment knee replacement manufactured by mako surgical corporation. Pending (b)(6) superior court, product defect complaint filed. Fda approval was obtained based on "substantially similar" devices. The device and process by which the device is implanted has caused much injury and problems and re-evaluation of its approval for use should be investigated. Two subsequent "corrective surgeries" have not salvaged the prosthetic and a total knee replacement is likely. (b)(6).

 

It has really amazed me that with the recent Depuy ASR and Zimmer MOM recall/class action ortho world, why any surgeon would trust a wiz bang robot with unproven metal and plastic. It takes a long time to get it right on both the design and manufacturing side. I don't see it working out with Mako. How could this company expand as pricing continues to plummet? The other manufactures all have patient specific disposable uni's coming out soon and far more experience with total knees. Buyout would be very unlikely as well.

 

At AAKHS right now. Have not heard one positive thing about Mako. Hope analysts are around to hear the truth from the horse's mouth.

 

They should change their name to MAKO used cars......

 

Mako CEO was supposed to present today. Looks like he was a no show.

 

Heard Mako provides money back to hospitals for use in marketing and advertising. How does the accounting work for this? Sounds like a kickback. How many surgeons are being paid to be principle investigators? How many robots are installed?

 

how many surgeons 'use' the hospitals money to acquire the robot, do a few to keep them happy, get it known in the community, and then to totals ?
How many 'consultants" does Mako have ?
Who makes their Uni component, and what are the outcomes ?
What poly do they use ?
Lots of questions....

 

Who makes their hip implants?
What is the safety record of those implants, when competitors have 10+ years plus of clinical data? Poly and tribology are not trivial sciences...
What are their design, quality and manufacturing system controls like?
Is the hip software so revolutionary that it justifies the high degree of direct to patient marketing?
If I come up with a more comfortable surgeon chair, can I market the procedure as revolutionary...the CHAIRoplasty!

These would be good questions for analysts to ask during the upcoming conference call

If your symptoms aren’t responding to non-surgical solutions, or your pain can no longer be controlled by medication, you may be a candidate for MAKOplasty® Total Hip Arthroplasty, a procedure also known as total hip replacement. Only your surgeon can determine if MAKOplasty® Total Hip Replacement is right for you.

 

So patients are thinking that Makoplasty is minimally invasive. Is the Makoplasty Total Hip really that much more minimally invasive than a conventional approach???

 

dont know who makes the Mako uni. (however im betting its European) If you read the quarterley reports, they have already switched to metal backed tibials because of high failure rate with all poly. (Gee, I thought the robot would have known this ??)
They signed an agreement with Corin for a stem and shell/insert. It looks like a Corail knock off. its very new, so no clinicals etc.
Again, whats it say when they have to go 'offshore' to get implants.
Ther more questions asked of this company, the quicker they will be DOA.

If you have time and want to have some fun, register on the Mako message board on Yahoo finance and say anything negative and watch the investors agressively defend the company !!

 

You should post the cafepharma link on the yahoo board...

 

False or Misleading Labeling

Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular. This phrase "false or misleading" is not confined in meaning to untrue, forged, fraudulent, or deceptive. In fact, the word, statement, or illustration may be true in the strict sense of the word; however, the labeling can be deemed by the FDA to be in violation of the law if it proves deceptive to the customer. It is not a necessary condition that the labeling should be flatly and baldly false; the work "misleading" in the Act means that labeling is deceptive if it is such as to create or lead to a false impression in the mind of the reader. A "false impression" may result not only from a false deceptive statement, but may also be instilled in the mind of the purchaser by ambiguity or misdirection. It may also be caused by failure to inform the consumer of facts that are relevant to those statements actually made. In other words, the label that remains silent as to certain consequences may be as deceptive as the label that contains extravagant claims.

A device can be misbranded by making reference to a medical device registration number assigned by FDA in response to a firm's filing requirements under the FFDCA. Section 807.393 of 21 CFR, misbranding by reference to establishment registration or registration number states that the assigned numbers do not constitute official FDA approval of the device.

Examples of false labeling include:
• incorrect, inadequate or incomplete identification;
• unsubstantiated claims of therapeutic value;
• inaccuracies concerning condition, state, treatment, size, shape or style; and
• substitution of parts or material;

Examples of misleading labeling include:
• ambiguity, half-truths, and trade puffery;
• expressions of opinion or subjective statements; and
• failure to reveal material facts, consequences that may result from use, or the existence of difference of opinion.

Examples of other objectionable labeling practices include:
• deceptive pictorial matter;
• misleading testimonials;
• misleading list of parts or components; and
• use of brand or trade names instead of "established names."

 

oh oh, based on misleading etc., looks like Mako will have to stop running their 'town hall' meetings at the seniors homes where they tell the people that they have the answer for knee pain!!!