Last year the FDA approved Boston Scientific’s subcutaneous ICD, the first ICD that can defibrillate the heart without using leads threaded to the heart through the blood vessels. Those leads are the source of many sophisticated pacing features in today’s ICDs, but they are also the main source of ICD-related complications, and, in several well-publicized…
New Subcutaneous ICD Said To Pose ‘Existential Crisis’ For Older ICDs
Study Questions Role Of Dual-Chamber ICDs For Primary Prevention
Dual-chamber ICDs are implanted in a majority of primary prevention patients without a pacing indication who receive an ICD. Although there are a number of theoretical advantages with dual-chamber devices, these devices are more likely to cause complications. Although CMS requires providers to justify the medical necessity of dual-chamber devices, current guidelines from the AHA/ACC…
St. Jude Seeks Retraction of Hauser Article On Riata Leads
St. Jude Medical is seeking the retraction of an article by Robert Hauser in Heart Rhythm linking the company’s Riata and Riata ST leads to 20 or more deaths. In a press release (see below) issued on Friday afternoon, St. Jude alleges numerous mistakes and oversights in the Hauser paper. In a brief statement to CardioBrief, Hauser wrote:…
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