CambridgeMicrovolt T-Wave Alternans Strongly Encouraged by CMS; CMS Plans a Follow-On ICD Database Registry Which Could Include MTWA
BEDFORD, Mass.--(BUSINESS WIRE)----Cambridge Heart (OTCBB-CAMH) announced today that it strongly supports the implantable cardiac defibrillator (ICD) National Coverage Decision issued yesterday by the Centers for Medicare and Medicaid Services (CMS). In the decision, CMS strongly encourages the inclusion of its Microvolt T-Wave Alternans (MTWA) test in clinical trials, registries and other data collection systems.
Following an extended analysis and recent publication of the of the Sudden Cardiac Death - Heart Failure Trial in The New England Journal of Medicine last week, CMS broadly expanded the coverage indications for ICDs. In the coverage decision, CMS acknowledges that the large proportion of patients studied never received any therapy from their ICD, making additional risk stratification reasonable and necessary. CMS also expressed concern that the available evidence, including six recently published ICD clinical trials, does not provide a high degree of guidance to providers to target ICD devices to patients who will clearly benefit. As a condition of payment, CMS is requiring that every implanted patient be enrolled in a FDA clinical trial or a database registry.
With the initiation of coverage for expanded ICD indications, CMS will utilize an existing QNet/CMS database infrastructure for the initial registry to capture the minimum necessary information for ICD reimbursement.
CMS is actively planning a follow-on ICD registry, which will be developed with input from cardiology specialty societies, product manufacturers, health plans and experts from the clinical community. Cambridge Heart will work with CMS and these groups to include MTWA as one of the data elements of the follow on registry. With respect to MTWA CMS stated, "We do strongly encourage the inclusion of MTWA in subsequent clinical trials, registries and other data collection protocols in order to further evaluate this promising risk-stratification technology and will work with the stakeholders involved in the subsequent data collection systems to include this information. CMS will continue to support these studies that collect this type of information."
"We are pleased to see that CMS has acknowledged the important role that Microvolt T-Wave Alternans testing can play in helping to assure that those patients most likely to benefit receive life saving ICD therapy," stated David Chazanovitz, President and CEO of Cambridge Heart. Chazanovitz further remarked, "We are very supportive of CMS' broad vision and approach to assuring appropriate care for Medicare patients. We look forward to working with CMS and other stakeholders to enable the seamless inclusion of MTWA into the enhanced ICD registries."
About the Cambridge Heart Microvolt T-Wave Alternans Test
The Cambridge Heart Microvolt T-Wave Alternans Test measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. These tiny heartbeat variations - measured at one millionth of a volt - are detected in any clinical setting where titration of the heart rate is possible. The preparation for the test consists of placing proprietary sensors on a patient's chest. Extensive clinical research has shown that patients with symptoms of or at risk of life threatening arrhythmias who test positive for T-wave alternans are at significant risk for subsequent sudden cardiac events including sudden death, while those who test negative are at minimal risk.
About Cambridge Heart
Cambridge Heart is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. Using innovative technologies, the Company is addressing such key problems in cardiac diagnosis as the identification of those at risk of sudden cardiac arrest. The Company's products incorporate its proprietary technology, Microvolt T-Wave Alternans, and are the only diagnostic tools cleared by the U.S. Food and Drug Administration to non-invasively measure microvolt levels of T-wave alternans. The Company, founded in 1990, is based in Bedford, Massachusetts and is traded on the OTCBB under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com
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