Medical Device Daily Washington Editor
Just when you think the 510(k) path for device clearance cannot possibly encounter more ill will, you discover that's not the case.
The controversy over the implantation of the Myxo ETLogix 5100 annuloplasty ring at the Bluhm Cardiovascular Institute (Chicago) of Northwestern University (Evanston, Illinois) revolved around a complaint filed with the university in September by Nalini Rajamannan, MD, a cardiologist at Bluhm, who asserts that the Myxo was still an investigational device when it was implanted into the mitral valve base of patient Antonitsa Vlahoulis in April 2006.
According to wire service reports, Rajamannan and Vlahoulis later conveyed their concerns to Senate Finance Committee staffers, and the matter landed in the lap of the committee's ranking GOP member, Chuck Grassley (R-Iowa).
Grassley has since inked letters to the hospital and FDA asking about the regulatory status of the device. The letter to the agency states that the Iowa Republican "recently received troubling allegations that Edwards Lifesciences' Myxo ETLogix 5100 Ring ... has not been approved and/or cleared for marketing by the Food and Drug Administration." Grassley has apparently requested records of all correspondence between Edwards and FDA over the device by Jan. 5.
The surgeon who implanted the ring, Patrick McCarthy, MD, is said to have invented the underlying technology, but he is also reported to have stated that he had a number of products at his disposal at the commencement of the mitral valve repair procedure for Vlahoulis. By some accounts, the patient is disturbed somewhat by the fact that McCarthy is the inventor of the device and receives royalty payments on sales (Edwards has in the past reported that global sales of the Myxo were down to less than $500,000 in the first six months of this year), but McCarthy apparently invented the device several years ago while still employed at the Cleveland Clinic (Cleveland).
Vlahoulis experienced inflammation in the mitral valve leaflets earlier this year, a development that sparked the controversy, and is now a candidate for a heart transplant. She also apparently suffers from cardiac electrophysiology problems, as indicated by the fact that a Cox-Maze procedure was performed at the time of the mitral valve repair and that she is now said to need a pacemaker.
Vlahoulis signed a consent form to have her data added to a database dealing with heart valve disease, but nothing specific to a device connected to treatment for a failing mitral valve. McCarthy and the university have maintained that Edwards filed the appropriate paperwork to clear the modifications to the ring, which are said to deal with the shape of the ring, from a vaguely oval shape to a triangular shape with rounded corners.
FDA spokeswoman Peper Long told Medical Device Daily in an e-mail exchange that the agency "will respond directly to Sen. Grassley on the questions and issues raised in his correspondence, all of which we take very seriously and will give full consideration." Long also stated that device makers "with a cleared device on the market can, in some instances, make changes or modifications to the product without needing to submit a new 510(k)," per a guidance published in 1997 titled, "Deciding When to Submit a 510(k) for a Change to an Existing Device."
However, all the recent controversy over 510(k)s may force a change to that guidance, especially if the upcoming GAO report on the program – said to be due for publication Dec. 19 – casts an unfavorable light on the clearance process.
CMS proposes NCDs for surgical errors
The Centers for Medicare & Medicaid Services is tightening the screws on medical care that yields negative or equivocal results and to that end has proposed final decision memos on three preventable surgical errors.
According to the Dec. 2 statement, the three national coverage determinations (NCDs), deal with performance of the wrong surgical or other invasive procedures performed on a patient, a surgery performed on the wrong body part, and surgery performed on the wrong patient. These three are among the so-called "never events" as listed by the National Quality Forum (NQF).
Acting CMS Administrator Kerry Weems, who presumably is on the job market as of the Jan. 20 inauguration of President Barack Obama, said in the statement, "these types of surgical errors can cause serious injury or death to beneficiaries and result in increased costs to Medicare due to the need to treat the consequences of the errors." Weems also stated that policies covering surgical errors "are important steps for Medicare in working to reduce or eliminate their occurrence and their associated payments."
The CMS statement points out that the move toward non-payment for surgical errors was encoded in the Deficit Reduction Act of 2005 and that the proposed NCDs would, assuming they go through, take force as of Oct. 1, the first day of fiscal 2009. CMS also indicated that it is "exploring how to adapt this policy to its other payment systems."
In this application, non-payment of hospital-acquired conditions (HACs) would apply to the hospital in-patient prospective payment system, or IPPS. The statement does not describe the reason for concluding that "not all the conditions included on the NQF list of never events can be adequately addressed by the HAC payment provision," but the statement observes that as NCDs, these policies would affect not just hospital reimbursement, but also payments to providers and "any other healthcare providers and suppliers involved in the erroneous surgeries."
CMS intends to accept comments from the public until Jan. 1 and will issue final versions of the NCDs 60 days later.