The electronic pacemaker industry could be in for quite a jolt. If realized and proven successful, a biology-inspired technology could someday supplant the heart-regulating electronic implants, effectively changing the face of cardiac pacing.
At the BIOMEDevice Boston conference last month, I attended a presentation on the evolution of biomaterials given by consultant Arthur Coury, who boasts an impressive medical device industry resume that includes a 17-year stint at Medtronic. During the talk, Coury brought up the work being done by Professor Eduardo Marbán, first at Johns Hopkins University and more recently at Cedars-Sinai Heart Institute, involving the conversion of ventricular myocytes into biological pacemakers via a variety of gene- and cell-therapy approaches.
"The successful generation of spontaneous rhythmic electrical activity in vivo indicates that genetically engineered pacemakers may be developed as a possible alternative to electronic pacemakers," Coury said. "I believe someday that the pacemaker industry might be somewhat at risk if this [technology] is developed."
This is a powerful comment that really stuck with me long after the presentation was over. As with any technology, pacemakers have their drawbacks, of course. They must be surgically implanted and, if necessary, explanted; feature a finite battery life; and can experience dangerous lead fractures. Furthermore, reports indicate that implant hacking or viruses from Internet-connected devices could soon pose a legitimate threat to pacemaker patients.
But could electronic implantable pacemakers really soon be obsolete? According to Marbán, it's a distinct possibility--although it won't happen overnight. "Yes, but we need to begin with baby steps," he told me. "Our favored clinical development paradigm focuses on a 'bridge-to-device' indication in patients who are pacemaker-dependent but who have hardware infections necessitating explantation. A temporary biopacemaker in such patients would enable a hardware-free interval for intensive antibiotic therapy before eventual reimplantation of a permanent electronic device. If biopacers work in this niche indication, we would have proof of concept of their utility in human therapeutics. Further, broader indications would surely follow in due course."
From a patient perspective, the biological pacemaker sounds like a potentially less risky and more convenient alternative to the traditional electronic implant. For a pacemaker manufacturer, however, such an advancement could change everything for the multibillion-dollar industry. And it probably will. After all, Marbán's team isn't the only one out there investigating the feasibility of a biological pacemaker. It may just be a matter of time.
While companies involved in pacemaker design and development are surely keeping an ear to the ground, is that enough? If--and possibly when--a biological pacemaker is realized, competition in this new area will become fierce as traditional designs are phased out. It may not be easy, but pacemaker OEMs need to be prepared to adapt to such a change without missing a beat.