Image Courtesy of EBR systems
Should we or should we not remove the cables from our devices? – Is the question that entire medical device OEM family is asking to its R&D team.
Though majority of the players are still seeking answer to this question, pacemaker suppliers are believed to have frozen on their answer. They have picked up the choice of going leadless / wireless. Below are some of the activities that took place around leadless pacemakers in recent past and paint a picture of where the sector is heading in terms of innovation.
Approvals, Funding, Clinical Trials, Law-suits, Acquisitions
First leadless pacemaker hit the market in 2011 from CRM device pioneer St Jude Medical. Thanks to its initial investment on Nanostim that gave an opportunity to the company to buy the latter’s assets and gets an easy entry into booming leadless market.
Nanostim choose European market to debut its technology.Though it had an early hiccups, it’s believed to have come on track soon enough, avoiding the industry’s uncalled criticism on innovative solution. Path of leadless pacemaker was then chosen by Medtronic, medtech behemoth known for its product diversity and huge therapeutic focus. Medtronic launched its device: Micra in April 2015.
The only medtech giant who was missing from the party was BSC, which on its recent investor day expressed interest of venturing into market, market which is projected to generate overall sales of USD 700 million by year 2016.
While the leaders of the industry are structuring their growth strategies, start-ups are closing funding rounds. One such company is EBR systems which has been backed by Split Rock Partners and SV Life Sciences. EBR system’s technology platform recently received CE mark, and is different from other leadless pacemaker in terms of area of impulse delivery. While the Medtronic’s and St Jude products provide the impulse to right ventricle, EBS’s WiSE powers left ventricle.
After proving its point in EU markets, players have commenced their journey into US geography. Both St Jude and Medtronic have kick-started their individual trials for FDA submission, and are likely to share the study results in coming days.
Leadless pacemaker market has been an interesting sub-category to watch, primarily because of issues that it addresses from its counterparts (conventional pacemakers). Casualties from the traditional platform had been the talk of the medtech town, where riata lead failure and Medtronic pacemakers issue have been wakening events for the entire medical device industry. While the former event resulted in St Jude shelling out more than USD 10 million in the form of settlements, latter resulted in increased emphasis on post market surveillance.
Leadless pacemakers have put a lot of questions to rest, but industry always demands for more. This brings to our final point, on where OEMs should pause & celebrate on their pacemaker developement landmark.
All the current solutions are around single side impulse delivery and what would really change the face of cardiac rhythm management, is a single pacemaker capable of delivering to both sides of the heart. St Jude Medical, who has made claims of working on similar device type surely seems to have an upper hand in comparison to its counterparts. What would be good to see is, start-ups channelizing their effort to develop similar platform. This would give an opportunity for established players to either fund the technology or probably acquire it.