A Medical Device Daily

Cardiologists trying to assess a patient's vulnerability to sudden cardiac death have more instruments available than ever before, including measurements of the microvolt t-wave alternans (MTWA) phase of the heartbeat, during which the ventricles recharge prior to contraction.

However, the currently reimbursed method of measuring the MTWA, known as spectral analysis, is subject to noise and is little help in measuring the MTWA when the patient is active. Hence cardiologists and electrophysiologists might be seen as keen on getting the Centers for Medicare & Medicaid Services to reimburse for MTWA analysis employing the modified moving average (MMA) approach, which researchers are increasingly convinced yields the more relevant data set.

The lynchpin in this discussion is the perception that most incidents of irregular heartbeat occur during other than a resting state, thus suggesting that an unstressed measurement underestimates a patient's vulnerability. According to CMS's Febuary 14 proposed decision memo, the MMA measurement requires that the patient wear a monitor for 24 hours and can be used while the patient is on a treadmill.

CMS accepted the petition, filed by GE Healthcare (Waukesha, Wisconsin), last August and expects to render a decision by May 14.

According to CMS, the first 13 of the public comments weighed heavily against coverage for MMA testing, citing a lack of sufficient evidence to back the idea. One of those in favor acknowledged the need for randomized trials, and the other was "from the same organization as the entity that requested the reconsideration."

CMS noted that "many patients have indeterminate results" from T-wave testing and that the data behind the use of MMA "is relatively sparse," citing a study published by Nieminen, et al, in a publication in the British Medical Society's Cardiovascular Disorders in 2006. The agency deemed the patient pool sizeable, but nonetheless questioned "the discrepancy between the 1,037 subjects in the 2007 study ...and the availability of much more data at the time the study was published." CMS also pointed to the lack of a control group as "a significant methodological weakness."

As a result, CMS proposes to stand pat on the issue, but the agency said it would look at comments "that include new evidence we have not reviewed here." As matters stand, MTWA testing is only reimbursed when conducted with spectral analysis.

FDA cited IRB for lack of experience

Warning letters to institutional review boards (IRBs) are a relative rarity, so when the agency wrote up Coast Institutional Review Board (Colorado Springs, Colorado) last month citing a lack of experience for one of its members, it seemed to affirm the growing perception that the clinical trial industry is operating at close to capacity.

According to FDA, Coast appointed a member of the IRB, who "lacked the requisite relevant experience to conduct expedited reviews," to conduct an expedited review of a recruiting advertisement for a study (the name of the study and the IRB member were both redacted). The agency stated further that the ad did not qualify for an expedited review partly because the ad did not cover a study item involving minimal risk and the relevant data were not listed in the Federal Register. However, FDA noted that a voting majority of the IRB had previously disapproved of the change to the ad.

The unnamed member of the board was assigned the expedited review on March 19, 2007, four days after disapproving the ad. FDA noted that the board member was appointed to the board March 19.

The warning letter, which was addressed to CEO Darren McDaniel, also said that McDaniel "lacked the authority to designate anyone to conduct expedited reviews." The agency added that none of the IRB members were able to recall being informed of the expedited review. Coast was unable to forward documents related to the inspection by press time.

Firms bypassing FDA on way to market

In an age of infoglut, it is difficult to imagine that device makers might be ignorant of FDA's requirements, but a recent rash of warning letters suggest that many in the U.S. believe they can just set up a web site and go at it with no regulatory oversight.

The March 21 warning letter to Acacia Engineered Products (Franklin, Tennessee) stated that the company's IsoBalance, a clinical assessment tool for balance disorders, lacks any kind of authorization by the agency. The device is currently marketed by Iso Technology (Tweeds Head, Australia), but the warning letter noted that Acacia is the manufacturer. However, a web search did not disclose a web site for Acacia, and attempts to contact the company for comment were unsuccessful.

Somewhere at FDA must be a bulletin board for some of the more absurd product claims ever seen, but a recent FDA warning letter hinted that some device makers have either an interesting sense of epidemiology and geography or an interesting appreciation of language.

The March 21 warning letter to Laser Therapeutics (LT; Centerville, Massachusetts) addressed the firm's marketing of the Softlaser "under the trade names of Beurer, Etrans and Vitalmed in the United States" minus a PMA or a 510(k). According to FDA, the device is indicated for acne, eczema, herpes cold sores, psoriasis and ulcers.

However, the warning letter gets more interesting as FDA notes that LT attached the disclaimer that these are "Non-U.S. Conditions," according to FDA, apparently an attempt to avoid the adulteration and misbranding that would result from attempts to market the device in the U.S.

FDA's position is that the language "is not a viable alternative" to making explicit the lack of authorization to market the devices in the U.S. because "neither the disclaimer nor the qualifying language can rectify the message conveyed by the treatment claims."

At press time, LT had not responded to calls for comment.