Monday, July 19, 2010

Slap My Wrist, I've Been A Bad Girl!

On July 2nd, 2010 the FDA issued and addressed a warning letter to Ms. Ann Prewett and Replication Medical. It seems Big Brother was made aware that Replication was marketing the EnGuard (I always think of the Three Muskateers when I hear that), without marketing clearance or approval in violation of the Act.

In all likelihood, the mea culpa was related to off-label use, claims made in marketing material and a White Paper. These claims were made outside the scope of their 510(k) clearance. The EnGuard was cleared with limitations as a cover for vessels (Aorta and Vena Cava) after anterior vertebral surgery. It seems like Annie Oakley could use some real help at Replication. Many of the companies with these barriers are having a tough go of getting these products into the marketplace. Obviously, anyone looking to sell these products has to have a surgeon in their territory that loves to perform 360's, and TSB is not talking about aerials. So it seems like the powers to be at Replication have until the this week to respond to the FDA. Good luck and you know what the FDA will say to you, "don't ever let this happen again." A slap on the wrist is better than getting slapped around.


  1. Mea culpa? Did Replication fall on a sword? Or has there only been a warning letter? Or were you involved? I don't get it.

    Btw, once you get a warning letter you are under close scrutiny for years. Suddenly each MDR is reviewed more closely, websites and booths are visited to check your marketing, and field inspections seem to occur right on time. Slap on the wrist or are you uninformed?

  2. I know that an adhesion barrier is class 3 and requires clinical trials. Several precedents on that. What I don't understand is the class 2 indication as a vessel protector for use following anterior vertebral surgery. Does not fda's own clearance of that indication suggest it's use as an adhesion barrier? Else, why would one chose to cover those vessels after anterior vertebral surgery? What other purpose does the indication hold? Seems a bit of a raw deal to me.

  3. Looks like there is some understandable confusion here. It appears as though EnGuard(TM) is a rare Class III device that was, however, cleared under a 510K, but 'with limitations'. The device was cleared 'for use as a cover for vessels following Anterior Vertebral Surgery', similar to other marketed vessel coverings. But because FDA acknowledged the possibility that this indication for use could be construed as an 'adhesion barrier' (which is regulated as a true Class III, under more stringent Pre-Market Approval standards), EnGuard's 510K clearance required that Replication Medical include the following information on all its promotional materials, as well as the product's packaging:

    "The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established."

    Adhesion barrier and vessel covering may sound very similar, but the difference appears to be in the claims made. FDA classifies 'adhesion barriers' as requiring PMA (Pre-Market Application) approval, which requires the submission of clinical trials under an Investigational Device Exemption to support the device's ability to prevent post-surgical adhesions.

    The 'vessel covering' indication, however, only claims to protect the blood vessels from injury during a future revision surgery, by providing a physical and visual plane of dissection that a surgeon can quickly see, so as to differentiate between scar tissue and the vessels.

    Semanitc? Perhaps, but the actual difference is in what the company is claiming its product can do, and the moment someone claims 'adhesion barrier' without a proper PMA on file, FDA pounces on it.

  4. Anonymous 1:18:

    You know what Wayne once said, "Excellent!" Thanks for the time that you put into explaining what happened. Party On Dude!

  5. Just remembered a great example of claims driving the regulatory process, offered by a more experienced colleague of mine.

    Take, for example, a tissue product (human, animal, doesn't matter) which is thought to have therapeutic qualities for wounds. These days, FDA is cracking down on therapeutic device claims, and, according to my more learned colleague, requiring safety and efficacy data to support these claims. In other words, a PMA.

    However, if you take that same tissue product, and only claim that it performs a 'wound covering' function, with no therapeutic claims whatsoever, you likely qualify for 510k clearance (assuming you show substantial equivalence to a marketed product, of course).

    The strategy here might be to get your 510k 'wound covering' product on the market, allow the end-user physicians to discover and write about the therapeutic qualities of your product, and generate revenue the whole time. Meanwhile, your product, hopefully, is amassing an independently-generated & peer-reviewed clinical profile which you can, if you choose, apply toward a future PMA wherein you do make therapeutic claims.

  6. The FDA is wasting it's time on the indications for Replication, when this company has always billed itself as a cover for vascular anatomy and not an adhesion barrier. Vascular Surgeons who see clincal value in this product do so because it provides a proven plane in the event of an Anterior spine re-do. Perhaps the feds can spend more time looking at off-label use of dynamic stab and BMP...oops they've already done that...