MINIATURE LEADLESS PACEMAKER – Beginning a new revolution in cardiac device industry

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Approximately 5 million conventional pacemakers are currently implanted worldwide (800,000 annually). Out of these, there are around 75,000 annual cases of lead failure are reported. To meet this immediate need and eliminate the complications involved with the lead wiring, researchers have developed a miniature leadless pacemaker.

Leadless pacemakers are designed to accomplish the same pacing grades as a standard pacemaker, but the process for implanting the leadless pacemaker is different. Just one-tenth the size of traditional pacemakers, leadless pacemakers are fully self-contained devices implanted within the right ventricle non-surgically using a catheter introduced via a vein in the leg. Unlike a standard pacemaker, a leadless pacemaker does not need the creation of a surgical pocket for the pacemaker, and it requires no leads.  The pacemaker battery life is also equivalent to that of similar standard single chamber pacemakers.

According to a research paper published at the 37th annual scientific sessions of the Heart Rhythm Society (HRS), which compared acute and mid-term adverse event rates from the multicenter LEADLESS II clinical trial of St. Jude Medical’s Nanostim leadless pacemaker with those obtained for transvenous pacemakers from a large U.S. insurance claims database, leadless cardiac pacemaker hold significant safety advantages over traditional transvenous cardiac pacemakers.

“Within one month of implantation, acute complications occurred in 12.8 percent of the transvenous pacemaker group, including lead-related adverse events in 7.6 percent, thoracic trauma in 3.8 percent, and infection in 1.9 percent. Those types of complications don’t apply to leadless pacemakers.

Mid-term complications (between one month and two years) were rare among the LEADLESS cohort (0.6 percent incidence) but were seen in 5.5 percent of transvenous pacemaker recipients, including additional lead-related adverse events in 2.5 percent and infection in 2.7 percent.”

Further advantages of a leadless pacemaker over a conventional pacemaker are avoidance of a surgical scar or lump under the skin where the pacemaker sits.  Additional potential benefits include evading the problems associated with lead wire placement and reduction in the risk of infections associated with it.

As of now, only two companies have developed the leadless pacemaker and are ready for marketing. In April 2016, Micra, leadless pacemaker by Medtronic has got the approval of US FDA. Nanostim, by St Jude Medical a similar leadless pacemaker is currently under the investigational phase in the US. While the both products have got their CE mark for their marketing in European Countries. Both these devices are implanted by catheter into the right ventricle, ideally near the apex, to facilitate single-chamber pacing without the need for the wired lead system integral to standard subcutaneously implanted pacemakers.

Although these leadless pacemakers are a major win for patients at risk of complications from traditional devices, the cost and potential limitations on how it performs could hinder its widespread use. The valuations of about $10,000 compared with conventional pacemakers that average about $2,500 is raising eyebrows, especially among hospital officials whose amenities receive lump sum Medicare payments for such procedures.

Around 75% of the total pacemaker implantations taken place in the USA in the past decade are for dual chambered. While the single chambered pacemaker implantations account to only 15% of the total users. Currently, both Nanostim and Micra leadless pacemakers are a single chamber, right ventricular pacing devices targeting the small part of total users. As of now, only St Jude Medical is developing a dual chambered leadless pacemaker which has a potential market of majority dual chambered pacemaker implantations. So, with many untapped opportunities present in the market, it can be the target of various cardiovascular device manufacturers.

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