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Current Medicare Criteria Comment

in this section: Recall | FDA Pacemaker Recall | Breaking News | Guidant Corporation Press Release | St. Jude Medical, Inc. Press Release | Nonischemic Dilated Cardiomyopathy Comment | MADIT II and SCD-HEFT Comment | Current Medicare Criteria Comment | April 2007 Recall--'Doctor's Letter' | Guidant Settlement Talks, 5.16.07 | FDA Q&A on 4/07 Recall | Settlement News, 7.20.07

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Initial Public Comments on Implantable Cardiac Defibrillators

BREAKING NEWS: 10.15.07--Medtronic, Inc., the world's largest maker of electronic heart devices, announced they are suspending sales of Sprint Fidelis leads. According to the FDA, these wires, used to connect defibrillators to the heart, may break or erode and may increase chance of injury. Learn more about the Medtronic Sprint Fidelis Recall.

Comment Seven
May 25-June 25, 2004
Comment #7:
Name: Gary Ross, DO MS FAAEM
Organization: St. John Hospital Medical Center
Date: May 28, 2004

The DEFINITE and COMPANION trials have truly demonstrated benefit to these devices. The current criteria Medicare uses for bivent devices is a disservice to our patients. I agree the criteria did move closer to the standard of care in Oct. 03, however for devices that have clearly shown improvement in morbidity and mortality, more than any medication we currently offer for heart failure patients, we should be more current. It appears that the QRS width is not needed as part of the criteria. Low EF of 35 and class II or III failure unrelated to a recent MI/revasc procedure is sufficient. The bivent ICD should have its own criteria and not be dependent on the ICD criteria.

The reimbursement also needs to cover the cost of the device and costs associated with the EPS lab.

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see also:

FDA Q&A on 4/07 Recall FDA Q&A on New Guidant/Boston Scientific Defibrillators Recall
FDA Q&A: April '07 Recall of Guidant/Boston Scientific Defibrillators

FDA Pacemaker Recall FDA Warns of Dangers: Guidant Pacemaker
FDA Says Guidant's Pacemakers are Dangerous - Is Your Life in Danger?

News & Warnings Guidant Defibrillator - Public Commentary on Defibrillators and the Guidant Recall
Guidant defibrillator recall public comment. FREE lawsuit information
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