St. Jude Medical Bets on Leadless Pacemakers

The leadless pacemaker has become enough of an innovation that St. Jude Medical recently laid down $123.5 million to get quicken its own pulse when it comes to getting one to market in the U.S.Little Canada, MN-based St. Jude announced its October acquisition of Milpitas, CA-based Nanostim shortly after Nanostim received CE Mark approval for a leadless pacemaker that is less than 10% the size of a conventional pacemaker. The FDA has also cleared the way for evaluation of Nanostim's technology in the U.S.

Pacemaker technology has considerably advanced since the first implantable pacemaker debuted in 1958. Pacemakers have become progressively smaller and programmable. They contain accelerometers, and can communicate wirelessly. But the device is still implanted in a "surgical pocket" away from the heart, with leads through the venous system connecting the device to the blood-pumping organ. In contrast, the Nanostim leadless pacemaker is designed to be implanted directly into the heart via a minimally invasive procedure. It is delivered using a steerable catheter through the femoral vein.Eric S. Fain , M.D., president of the St. Jude Medical Implantable Electronic Systems Division, goes as far as to call the Nanostim pacemaker as "one of the most important advances in the history of pacing technology."St. Jude Medical had already expressed interest in acquiring Nanostim and its AAA battery-sized device. Fridley, MN-based Medtronic continues work on a leadless pacemaker roughly the size as an antibiotic tablet. Natick, MA-based Boston Scientific is also working on a leadless design. Some have questioned whether leadless pacemakers could have their own drawbacks, including greater vulnerability to outside hacking if smartphones or other devices are used to program them.