Abbott and Medtronic are the only companies that have developed single-chamber leadless pacemakers; St. Jude recalled its version, Nanostim, in October 2017 after receiving 7 reports of lost telemetry and pacing output.
Although there were no reports of patient injuries associated with the malfunctions, St. Jude (now part of Abbott) is examining its entire leadless program, Dr. Avi Fischer, Abbott’s medical director for cardiac arrhythmias, told Medical Design & Outsourcing today at the DeviceTalks Minnesota event in St. Paul.
The market for dual-chambered conventional pacemakers is about 70% globally and 80% in the United States, Abbott officials told us today.
“That’s the need and we understand and appreciate that, which is why we’re looking at the dual chamber market as the market we’re focusing on,” Fischer said, adding that the company plans to develop a dual-chamber device regardless of where Nanostim stands today.
“It’s a stepping stone. It’s tough to run before you know how to walk,” he explained. “We had to establish the workflow, the implantation. It’s a whole new procedure for physicians. You want to start with the simple stuff before you get to the complex stuff.”
St. Jude was working on a dual-chamber leadless pacemaker before the acquisition, Fischer added.
“This is not something that we just conjured up now,” he said. “As part of our leadless program, we understood single-chamber, dual-chamber and the building upon technologies, obviously thinking about single chamber first but understanding the need to show proof that single chamber works, is safe, is effective, because this is a whole new technology.”
Leadless pacemakers represent the biggest change in the market in 25 years, added Mike Pederson, SVP of the cardiac arrhythmia & heart failure division at Abbott.
“Leadless devices have a potential to really be a dramatic change for that space but we have to do them well,” Pederson said. “We have to do them right.”