A proposed Centers for Medicare & Medicaid Services (CMS; Baltimore) national coverage decision involving Cambridge Heart’s (Bedford, Massachusetts) Microvolt T-Wave Alternans (MTWA) cardiac diagnostic testing may have far-reaching impact across a substantial swath of the cardiovascular device sector. In the proposed decision memorandum, which was issued following six months of analysis and a 30-day public comment period held last summer, CMS suggested that there is adequate quality of evidence to conclude that MTWA testing is “reasonable and necessary” for Medicare patients who are candidates for implantable cardioverter defibrillator (ICD) placement.

The Cambridge Heart Microvolt T-Wave Alternans Test measures what the company characterizes as “extremely subtle” beat-to-beat fluctuations in a person’s heartbeat called T-wave alternans. These heartbeat variations, measured at one millionth of a volt, are detected in any clinical setting where titration of the heart rate is possible.

The agency said: “Extensive clinical evidence has revealed that patients with symptoms of life-threatening arrhythmias who test positive for T-wave alternans are at significant risk for subsequent development of sudden cardiac events including death, while those who test negative are at minimal risk.”

Commenting on the proposed decision, David Chazanovitz, president and CEO of Cambridge Heart, said, “CMS’s proposed decision recognizes the value MTWA can bring to Medicare beneficiaries. Their recognition of the clinical importance of our patented analytic spectral method is vital in assuring the predictive values cited in the published literature.”

While the major players in the ICD market – sector leader Medtronic (Minneapolis), second-place Guidant (Indianapolis) and third-place St. Jude Medical (St. Paul, Minnesota) – all have supported trials of the Cambridge Heart test as an experimental approach to determining the appropriateness of treatment, some industry watchers say that the CMS move could in fact rein in the near-runaway growth prospects in that space.

CMS, which now is seeking public comment on the proposed decision in an open comment period slated to end on Jan. 21, gave a noteworthy boost to the companies making ICD products with its decision early this year to greatly expand Medicare coverage of such implants.

That decision was based on the publication in the New England Journal of Medicine’s Jan. 20 edition of the results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Among those findings: ICDs cut the risk of death in heart failure patients by 23%.

Almost immediately following the publication of the NEJM article – at light speed by usual Washington regulatory standards – CMS announced greatly expanded coverage of ICD implantations, and private insurers followed along.

That expanded coverage in turn inspired those who invest in such firms to pour money into the shares of the big players in the sector, a run-up that continued until problems related to both ICDs and pacemakers negatively impacted the valuation of Guidant in particular.

Now the specter of CMS possibly riding a T-wave alternans coverage decision to a point where it might be used as a basis for making decisions on whether a patient might not benefit from a vastly more costly ICD implant has some saying the rosy prospects for the implantable sector may be of a lesser hue.

It’s the “minimal risk” part of the CMS statement that could have much broader implications for the overall ICD market outlook. If patients whom cardiologists are eyeing as potential recipients of such devices turn out to have a negative predictive test for T-Wave Alternans, they and their physicians may then agree to continue to pursue a pharmacologic treatment rather than implanting an ICD.

In November, Cambridge Heart cited three presentations given at the annual scientific sessions of the American Heart Association (Dallas) in the organization’s home city, with those presentations collectively representing 2,358 study participants. The company said the presentations “further validate Microvolt T-Wave Alternans as an independent predictor of sudden cardiac death and sustained ventricular events regardless of the patient’s ejection fraction (a measure of the heart’s pumping ability).”

In evaluating the predictive ability of Microvolt T-Wave Alternans, researchers at the Lindner Clinical Trials Center (Cincinnati) concluded that “this non-invasive diagnostic test is a strong and independent predictor of mortality and appropriate ICD therapy among MADIT II and SCD-HeFT eligible patients with ischemic cardiomyopathy.”

Elizabeth Kaufman, MD, of Case Western Reserve University (Cleveland), said another study indicated that in patients with left ventricular dysfunction, an indeterminate MTWA test predicted death or sustained ventricular arrhythmias at least as well as a positive test and that conversely, a negative MTWA test is associated with a very low risk of death or sustained ventricular arrhythmia.

In the third presentation, Dr. Takanori Ikeda of Kyorin University (Tokyo) evaluated seemingly low-risk patients with an ejection fraction equal to or greater than 40% who also had experienced an acute myocardial infarction. In that study, each patient was evaluated with 10 different prognostic indicators – including signal-averaged ECG and non-sustained ventricular tachycardia on Holter monitoring in addition to MTWA. After analysis, MTWA was found to be the most powerful predictor. The conclusion was that in heart attack victims with preserved left ventricular ejection fraction, MTWA was not only a strong predictor of sudden cardiac death but that it may be useful in identifying patients in such a population who need implantable defibrillators.

As auction continues, more issues for Guidant

Even as the auction to acquire Guidant (Indianapolis) dominated the news through much of January (see story on page 7), the company was facing still more problems with its implantable devices. Guidant said it had identified a second batch of older-model pacemakers that are at risk of malfunction due to a problem with a sealing component. The company recommended physicians reassess their patients due to the discovery of additional devices with the potential defect. The company reported 145 incidents of malfunction related to the seal problem, and it estimated 16,000 of the affected devices remain implanted in patients worldwide.

The company said this new leak disclosure adds to a previous physician notification made this past July. At the time of the first notification, the company said that as of July 11 it had identified 69 devices that may have exhibited this failure, from about 78,000 devices distributed with this component, with about 28,000 devices still implanted worldwide.

It said that no failures were reported for the first 44 months of device use but that “the likelihood of occurrence increases with implant time.” Of the 28,000 devices identified and implanted worldwide, 18,000 of them remain in service in the U.S., with an average implant age of 69 months. As of Jan. 9, a total of five reported incidents out of the second identified patient population of 54,000 represented a rate of occurrence of 0.009%. Guidant said it has confirmed hermetic seal degradation in two of the five reports. It is estimated that 19,300 devices in this second population remain implanted worldwide.

At the time devices in the second population were assembled, the company said hermetic sealing components susceptible to gradual degradation were mistakenly mixed with a much larger group of non-susceptible components. The devices in this latest notification were manufactured between Oct. 19, 1998 and Dec. 5, 2000.

The company in late December also reported more failures of its implantable cardioverter devices. With the report of 18 more failures and one patient death, clinical failures of the devices totaled 35, with five patient deaths.

Mid-January also saw the preliminary court moves as Guidant headed toward a February trial to consider charges by two people that allege they have been harmed by the Guidant devices. The New York Times – which has led the charge in exposing the severity of the malfunctioning devices – won access to handwritten notes and copies of PowerPoint presentations which it said indicated that the company knew it was selling defective devices.

The effort came with no small amount of rhetoric from the lawyers for the plaintiffs in the case. Bob Hilliard, an attorney with Hilliard & Munoz (Corpus Christi), said that the documents contained “evil secrets.” He added: “Sunshine is the best disinfectant, and now that the media are involved, hopefully the truth will come to light that these devices can kill people, and that Guidant doesn’t seem to care,” Hilliard said. Hilliard is representing Louis Motal and Beatrice Hinojosa, as well as hundreds of others alleging injury by Guidant defibrillators.

The company responded by saying that the documents demonstrated that the company was “acting responsibly” in attempting to determine the extent of the problems.

Edwards awarded $37.5M by Medtronic

Edwards Lifesciences (Irvine, California) last month entered into an agreement with Medtronic (Minneapolis) and Medtronic Vascular (Santa Rosa, California), resolving patent infringement litigation initiated in August 2003 by Edwards and Endogad Research (Sydney, Australia), the company formed by the clinician-inventors of the patents at issue. The alleged infringement involved certain patents related to modular or multi-part endovascular grafts especially suited for treatment of various types of aneurysms, including abdominal aortic aneurysms (AAAs).

In exchange for a payment of $37.5 million in cash to Edwards and Endogad, Medtronic has been granted non-exclusive licenses to the patents involved in the litigation, as well as to other patents relating to endovascular AAA grafts and delivery systems. Medtronic also has purchased delivery system assets to be used with AAA grafts. Edwards said it expects to record a special pre-tax gain in 1Q06 of about $20 million, after taking into account its agreement with Endogad and legal expenses.

Stuart Foster, Edwards’ corporate vice president, technology and discovery, said, “This resolution protects the interests of Edwards and our clinician-inventor partners, with whom we work to create new technologies for the treatment of advanced cardiovascular disease.”

Edwards and Endogad remain in litigation with Cook (Bloomington, Indiana) and W.L. Gore & Associates (Flagstaff, Arizona) regarding infringement of the patents that are owned by Endogad and exclusively licensed to Edwards. The products named in the original suit include Medtronic’s AneuRx Stent Graft and Talent Stent Graft Systems, Cook’s Zenith Endovascular Graft and Gore’s Excluder Bifurcated Endoprothesis.

Edwards’ global brands, sold in about 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Fogarty, LifeStent, Perimount and Swan-Ganz.

Bard, Boston Sci issue recalls

C. R. Bard (Murray Hill, New Jersey) said it is voluntarily recalling its Bard Composix Kugel Mesh X-Large Patch intended for ventral hernia repair. The recall does not affect any of the company’s other hernia repair products. The company is initiating the recall due to reports that the device’s plastic coil ring, designed to aid in its deployment, may not withstand the increased stress associated with certain surgical placement techniques. The company has received 24 reports of broken rings out of some 32,000 units sold since 2002, a rate of about 0.08%. Bard said it has notified affected customers and the appropriate regulatory agencies worldwide.

The three product codes involved generated sales of approximately $11 million in 2005, before the effect of the recall. The company said it expects to record a sales reduction and related charges associated with the recall in 4Q05, and those adjustments will cause results to be below previously stated guidance for the quarter. Bard said it remains comfortable with its previously stated guidance for 2006 of constant currency net sales growth of between 9% and 10% and diluted earnings per share equivalent to a minimum of $3.42, excluding the effect of FAS123R.

In another recall, Boston Scientific’s Stainless Steel GreenfieldVena Cava Filters with 12 Fr femoral introducer systems manufactured before March 10, 2004, have been recalled as of Dec. 2.The product code for these devices is M001505010. A vena cava filter is a small cone-shaped device implanted in the inferior vena cava, the large vein that carries blood from the lower part of the body to the heart. The filter prevents pulmonary embolism by capturing blood clots before they can be carried to the lungs. Boston Scientific said there have been reports of detachment at the bond between the carrier capsule and the outer sheath of the filter’s delivery system during the implant procedure, putting patients at risk of cardiac and pulmonary embolization. Potential adverse events include serious patient injury or death.

The recall does not affect vena cava filters that have been implanted in patients.

Thoratec: more than 200 in HeartMate trial

Thoratec (Pleasanton, California) reported that more than 200 total patients have been enrolled in the worldwide phase II pivotal trial of its HeartMate II LVAS (left ventricular assist system), the company’s next-generation ventricular assist device.

The company said it had received FDA approval to expand the number of centers participating in the bridge-to-transplantation arm of the phase II trial to 40 from the current 25. It said it expects the first of these centers to have institutional review board approval during the current quarter.

As of Jan. 6, 154 patients have been enrolled in just the phase II portion of the U.S. trial. This includes 79 in the BTT arm and 75 in the Destination Therapy arm of Phase II.

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