A Medical Device Daily

Vasomedical (Westbury, New York), a developer of enhanced external counterpulsation (EECP) therapy to treat and manage cardiovascular diseases, said it has been notified by the Centers for Medicare & Medicaid Services (CMS; Baltimore) that its application requesting consideration for expansion of coverage the therapy has been accepted.

The company currently markets the therapy for chronic stable angina and congestive heart failure and said it has been working to expand Medicare coverage for less severe angina and to include coverage for congestive heart failure (CHF) as a primary indication. The company earlier this year reduced its staff in order to conserve funds for increased focus on the CHF application (Medical Device Daily, May 6, 2005).

“We will continue our efforts to provide the clinical evidence and support of this non-invasive option for treating cardiovascular diseases,” said Thomas Glover, Vasomedical president and CEO. He said that the benefits of EECP therapy for treatment of angina and CHF, “including improvements in the ability to exercise, reduction in symptoms and improved quality of life, have been reported in numerous studies including the most recent PEECH [Prospective Evaluation of EECP in Congestive Heart Failure] trial results.”

CMS has started a public comment period – open until July 20 – on the clinical evidence evaluating ECCP therapy for Class II angina as well as the evidence for treatment of those with Class II/III stable heart failure. A proposed coverage decision memo date is scheduled for Dec. 20, Vasomedical said.

EECP employs a non-invasive pulsation strategy to increase circulation in areas of the heart with the intent to restore systemic vascular function, according to the company.

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