St. Jude scores the first CE-marked leadless pacemaker

October 18 ,2013 | By Anabela Farrica

Just a few days ago, St. Jude Medical, one of the biggest medical devices company worldwide, announced the acquisition of Nanostim Inc., a private developer of miniature leadless pacemakers. For of $123.5M, St. Jude became the owner of what is the only leadless pacemaker to make it to the market so far, thus concluding the two-year partnership between the two companies.

The NanostimTM leadless pacemaker is less than 10% the size of a conventional pacemaker and was designed to be implanted through a less invasive procedure than its predecessors. It is meant to be delivered to the heart using a steerable catheter through the femoral vein, eliminating the need to surgically create a pocket and insulated wires (or leads). This allow for an increase in patient comfort and quality of life and reduce the chance of complications.

This innovative pacemaker solution recently received a CE mark and it will soon be available in some European markets. It also received a conditional approval from FDA for its Investigational Device Exemption, and pivotal clinical trials to evaluate the Nanostim leadless technology are to begin in the U.S.

Initial results from the LEADLESS study conducted in Europe were presented in May and demonstrated overall device performance comparable to conventional pacemakers. Total implant procedure times averaged 28 minutes. Even with miniaturization, the device battery is expected to have an average lifespan of more than 9 years at 100 percent pacing, or more than 13 years at 50 percent pacing.

St. Jude’s move puts the company well ahead of others, like Medtronic and Boston Scientific, which are on the run for similar products. St. Jude first started helping Nanostim develop its technology and face the regulatory hurdles in Europe and the U.S two years ago. Besides the $123.5M released for the acquisition of the rights as the owner of the product, St. Jude is expected to release an additional $65M, as long as certain revenue-based milestones are met.

This purchase is expected to help St. Jude reverse its performance in the long-struggling cardiac rhythm management business which, after hundreds of layoffs and months of consolidation, has seen some modest growth in the third quarter of 2013.


Fierce Medical Devices

Medical News Today


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