Beyond miniaturization: What's next for leadless pacemakers? Closed-loop tech

The medical device industry has been working for more than a decade on miniaturization: getting pacemakers down to a tiny enough size that they can be minimally invasively inserted and cause fewer difficulties for patients. The result is the recent approval of Medtronic's Micra Transcatheter Pacing System, with others likely to come along from competitors St. Jude Medical ($STJ) and Boston Scientific ($BSX) in the next few years.

Up next likely are closed-loop systems: pacemakers that record patient data, transmit that data externally and enable adjustment based on that data by physicians or even, eventually, on their own as guided by advanced algorithms. These are similar to an artificial pancreas in diabetes, which automatically regulates insulin dispensation based on continuous monitoring of glucose data.

"We need to be able to get the data out of the body," Rahul Sathe, head of surgical innovation at Cambridge Consultants, told FierceMedicalDevices. "That may need to mean optimizing the device size and shape to transmit out of the body. The industry needs to shift toward how do we make these small implants smarter to sense physiological data and adapt in real time."

Micra Transcatheter Pacing System--Courtesy of Medtronic

Before joining the product development and consulting firm, Sathe was a senior mechanical engineer at Cameron Health. Boston Scientific acquired Cameron Health in 2012 for $150 million upfront with the potential for more than $1 billion in additional milestones tied to revenues. This technology is the basis for Boston Scientific's leadless pacemaker efforts.

St. Jude also acquired its leadless pacemaker platform, Nanostim, for $124 million upfront with an additional up to $65 million based on revenue milestones. Medtronic ($MDT), by contrast, developed its own leadless pacemaker in-house.

"The next 10 to 15 years will be about biosensing--the ability to sense and detect pressure, temperature, stress, strain as well as electrical and chemical interactions in the body," Sathe said. "Then they will be taking conventional or new modes of telemetry to communicate to devices outside the body, encrypting it to make sure it's secure." He expects startups, rather than the major medical device players, will take the lead on this sort of technology.

He sees the move toward value-based healthcare, the increasing involvement of patients in managing their own disease and health and the rapid evolution of enabling technologies such as advanced sensors, wireless communication and connected health ecosystems as driving this trend.

Making the closed-loop system work will be advanced algorithms that will need to improve clinical outcomes and patient satisfaction and reduce the cost of care. Sathe is a bit skeptical of the usefulness of artificial intelligence in this endeavor, but deems the potential of deep learning on this front interesting.

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