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Analyst: Leadless Pacemaker Adoption Could Be Rapid

Analyst: Leadless Pacemaker Adoption Could Be Rapid
St. Jude Medical won CE Mark a couple of years before Medtronic with their respective leadless pacemaker systems. Physicians are intrigued as both companies pursue US regulatory approval. 

St. Jude Medical, through its Nanostim acquisition, was the first to win regulatory clearance for its leadless pacemaker back in October 2013 in Europe.

Micra leadless pacemaker from Medtronic

Last week, Medtronic announced that it's own version - the Micra leadless pacemaker, the smallest in the world - has obtained CE Mark in Europe. Both products eliminate what many consider the weakest link in heart devices - leads - that have led to several instances of high profile recalls. Both products use a catheter that can deliver the implant instead of requiring a surgical incision to place conventional pacemakers and the creation of a pocket under the skin where those older generation pacemakers can reside.

And now, an analyst report based on a physician survey indicates that adoption of this novel leadless technology may be rapid. RBC Capital Markets conducted a survey of 50 electrophysiologists and an overwhelming 80% showed an interest in using the device, according to a research note from Glenn Novarro, a medtech analyst with the investment bank, on Monday.

Here's more from the note, with slight edits:

Today, [about] 64% of respondents believe leadless pacemakers can capture 0–5% of the US pacemaker market. Five years from now, nearly 70% of respondents believe leadless pacemakers will represent more than 10% of new pacemaker implants. This suggests market adoption could be rapid once a device is introduced into the market....

This should be welcome news to both Medtronic and St. Jude Medical.

The Nannostim Leadless Pacemaker from St. Jude Medical

Medtronic's Micra is implanted in the heart using a catheter snaked through the patient's femoral vein. Once positioned in the right ventricle of the heart, small tines are used to attach the device to the heart wall. Pacing is delivered using an electrode at one end of the pacemaker. Micra is repositionable and retrievable providing another advantage over traditional pacemakers, according to a Medtronic news release announcing the CE Mark. In addition, the leadless pacemaker is fully compatible with MRI scans and has an approximately 10-year battery life. Micra is 30% smaller than its counterpart from St. Jude Medical, a Medtronic spokesman told last year, adding that it can be easily repositioned without causing trauma to the cardiac tissue.

Meanwhile, in an interview in February 2014, when St. Jude Medical announced the first U.S. implant, the company's chief medical officer said that the Nanostim pacemaker can be retrievable over the entire lifetime of the patient, which means that patients don't have to be have two devices - one active and the other inactive - when the patient needs a new device. Mark Carlson, the CMO also declared that the Nanostim's introducer sheath  - the sheath through which the doctors implant the device into the vein - is smaller in diameter than what is required for the Medtronic pacemaker.

Both St. Jude Medical and Medtronic are currently conducting pivotal trials to gain approval in the U.S. St. Jude's trial was designed to enroll 670 patients in medical centers in the US, Canada and Europe. Medtronic's trial is designed to study 780 patients in about 50 centers in 20 countries. 

 Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected] and on Twitter @aparmarbb 

Stay abreast of industry trends at BioMEDevice Boston, May 6-7 at the Boston Convention & Exhibition Center
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