HRS 2010: Subcutaneous ICD Generates Excitement, Controversy

Article preview from Medtech Insight - June, 2010

In the years since the dawn of the ICD era in the 1980s, perhaps four expansions of the implantable cardioverter defibrillator have captured the imagination of electrophysiologists and signaled unqualified success for the major manufacturers of these life-saving devices. Now, a new generation of ICD--the S-ICD or totally subcutaneous ICD--has the potential to join those sophisticated devices as the next truly evolutionary development in the field. Interest in the S-ICD picked up steam this spring in Denver at the 31st annual scientific sessions of the Heart Rhythm Society, where researchers presented the latest clinical results with the device.

HRS 2010: Subcutaneous ICD Generates Excitement, Controversy

By Curt Werner

For an industry that prides itself on innovation, and life-saving innovation at that, the technological leaps coming from the cardiac rhythm management (CRM) sector have been surprisingly few since the first implantable cardioverter defibrillator (ICD) was placed in 1980. For a variety of reasons, the advances that do reach the market come mostly in fits and starts; evolutionary rather than revolutionary upgrades that generally impact device features and benefits.

On the other hand, Medtronic Inc.'s Revo MRI SureScan Pacing System, which won conditional US Food & Drug Administration (FDA) approval this spring as the first of probably many such systems that enable patients with an implantable device to safely take a magnetic resonance imaging exam, comes to mind as a more meaningful advance.

But manufacturers in this space still seem to spend an inordinate amount of time and resources rooting out recalls and the market difficulties that accompany them. Most notably was Boston Scientific Corp.'s recent recall and temporary shutdown of all ICD and cardiac resynchronization therapy defibrillator (CRT-D) sales earlier this year due to a regulatory glitch. ( See "Boston Scientific Recalls All Implantable Defibrillators, Suspends Sales," "The Gray Sheet," March 22, 2010; and "Market and Industry Briefs: Boston Scientific Resolves CRM Recall, Medtech Insight , April 2010.) The recall cost the company about $5 million in lost sales each day the products were off the market, and may have caused more permanent damage with respect to the firm's market share.

That is not to say the physicians who practice in the CRM field don't clamor for new devices that can prolong and save the lives of their patients. It's just that few new devices in this field appear worthy of the being truly classified as "game-changers." And that's why a new, but still unapproved, device is making waves among clinicians even before it earns approval from the FDA—approval that, while already granted in Europe, is still far from assured in the US.

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