Is Nanostim's Leadless Pacemaker the Future of Heart-Rhythm Technology?

The size of a AAA battery, a pacemaker from Nanostim (Milpitas, CA) could represent a considerable advance in the field of heart-rhythm devices. Now being tested in clinical trials, the Nanostim doesn't use leads that are used in conventional pacemakers and ICDs. Leads can fracture, become dislodged, and cause other problems like infection. Heart device leads have received a substantial amount of negative attention recently--especially St. Jude's Riata and Durata products. While the former was the subject of a Class I recall, the latter was recently shown to be safe by an independent analysis. An earlier analysis found that the Riata leads had problems with electrical failure.

Details regarding Nanostim's leadless technology have been scarce as the company has operated in stealth mode . The company's patents, however, offer hints to its capabilities and details continue to emerge from the firm's clinical trials in Europe. The Nanostim device has an internal battery with a lifespan ranging from eight to 17 years

The first implantable pacemaker debuted in 1958. Considerable progress has been made in the field since then and contemporary pacemakers have become progressively smaller, programmable, contain accelerometers, and can communicate wirelessly. They still use leads to pace the heart, however, which are placed through the venous system into the heart. Nevertheless, leadless pacemaker technology has been investigated for some time now. For instance, U.S. Patent 4256115 A, which was filed in 1980, describes "leadless battery operated cardiac pacemaker is embodied in a small disc-like case for attachment beneath the pericardium directly to the heart muscle." The concept is similar to Nanostim's leadless pacemaker, which is small enough to fit completely within the heart.

Medtronic continues work on a leadless pacemaker roughly the size as an antibiotic tablet. Boston Scientific is also working on a leadless design. It appears, however, that Nanostim is closer to commercializing its leadless-based technology. The company recently announced positive clinical data prompting renowned cardiologist Eric Topol, MD to recap the develop on Twitter with the statement: "Look Ma, no leads."

Incidentally, St. Jude has expressed interest in acquiring Nanostim and has declared its plans to do so by the end of the year.

Brian Buntz is the editor-in-chief of MPMN. Follow him on Twitter at @brian_buntz.

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