What is happening in leadless pacemaker market?

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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.

Conclusion:

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.

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Number of Medical Device Approvals in Aug 2015

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Why acquire a monitoring device company?

AcquisitionOff late there has been surge in deal counts amid medtech OEMs and monitoring device companies. Newly added to this row, was BSC and Preventice deal, where the former acquires exclusive marketing rights of latter’s  wearables . Direct peers of BSC namely Medtronic , St Jude have already boarded on the trend. Where Medtronic acquired Corventis,while St Jude bought CardioMeMs.

While the BSC exclusive marketing deal surfaced up a day ago, Medtronic, St Jude transactions could be mapped to last year, year that was quoted by some of the journals as Medtech M&A year.

Industry experts quote the rational to acquisitions, as a move to drive sales of business division that are under performing in comparison to their counterparts. BSC’s rhythm management division VP quotes” healthcare transformation as the reason for the move. He says

“As our healthcare environment continues to evolve, healthcare practitioners,administrators and payers are looking for solutions that identify relevant clinical insights from large volumes of patient data and integrate those insights to improve clinical decision-making,”

Financial details of the transaction were not divulged but exclusive marketing partnership was affirmed by leading medtech journals.

As the healthcare cost witness an increase on daily basis, payers and other healthcare providers are doing everything at their disposal to cut down the increasing cost. Leading players believe that, an working model involving monitoring of patients outside the hospital set up , along with usage of data that these devices generate could be instrumental in carving a new healthcare patient-doctor engagement model, which is likely to be more reliable and economical.

Since clinical actions would be driven by real time data analysis, the outcomes of model are bound generate best of results. All credit to be given to the innovative wearable from likes of Preventice, CardioMeMs, Corventis and many other start-ups who are looking to paint a better healthcare picture.

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