The Wider View: Can Medtronic’s souped-up Interstim hold off incoming new rival?

Medtronic is holding onto its monopoly of the US sacral neuromodulation market for now, and has introduced a new programming feature to enhance its existing InterStim therapy for overactive bladder and faecal incontinence. But the medtech giant may need to go bigger and bolder with its innovation in this space in order to stave off a new competitor on the horizon, Axonics.

What’s happened

Medtronic announced Monday that the US FDA has approved its new smart programmer that works together with its InterStim sacral neuromodulation system for treating overactive bladder (OAB), chronic faecal incontinence (FI) and non-obstructive urinary retention. The programmer serves to streamline the different device components of the InterStim system into a single Samsung mobile device, and the app installed on the device - developed by Medtronic - collects information on the patient’s therapy experience and it allows clinicians to programme the therapy based on these insights. Patients can also adjust the therapy themselves, within certain pre-set clinical parameters, using the programmer.

The wider view

Medtronic broke into the sacral neuromodulation scene with Interstim around 20 years ago, when the first-generation system was CE marked in 1996 then FDA-approved in 1997 to treat OAB. InterStim II followed in 2006, when it got European and US approval in 2006 for managing OAB and FI and the newer-generation system sported a smaller implantable device as well as a new patient programmer and an upgrade to the existing clinician programmer.

Medtronic’s latest move to upgrade its sacral neuromodulation system is focused on souping up the programming feature and what had been two separate devices - one for the patient, another for the clinician - has now become one single device, from electronics giant Samsung, and an app for more streamlined therapy management by the clinician and patient.

It makes good business sense, especially in an industry like medtech, to keep innovating and ensure your portfolio is refreshed by introducing enhancements to existing products. Medtronic’s upgrades to InterStim seems to come every decade, but spite of this relatively lengthy interval, the company still has monopoly of the US sacral neuromodulation for OAB/FI market the last 20 years.

Changes afoot

But the playing field is changing soon and Medtronic, if it wants to continue to hold the lead in this market, may not want to wait another ten years until the next enhancement to InterStim.

This competitive landscape change will come in the form of Axonics Modulation Technologies, which submitted to the FDA its premarket approval application for its r-SNM system earlier this month. Axonics said then that it expects the agency will complete a substantive review by early March 2019, with the earliest data for a decision in June. Axonics CEO Raymond Cohen had told FirstWord MedTech previously that if all goes well, the company could launch the product in the US in the second half of next year.

The r-SNM system is already CE marked and Axonics’ commercialisation activities are still in the early stages. However, Cohen had indicated that with the US accounting for nearly 90 percent of the worldwide uptake of sacral neuromodulation, that’s where the company will channel most of its resources.

Of course, Medtronic has had a head-start on Axonics; the company estimates that about 300 000 patients have been implanted with InterStim to date. But this is barely a dent in a market where over 37 million American adults suffer from OAB and nearly 20 million Americans have FI. Axonics believes that one of the key advantages r-SNM has over Medtronic’s device is that its rechargeable battery, which reduces the number of times the r-SNM neurostimulator needs to be replaced (at least once every 15 years versus InterStim’s approximate four-year replacement cycle, depending on programming parameters). The company is confident that this rechargeability, together with the substantially smaller size of the neurostimulator, will accelerate uptake of SNM therapy for OAB/FI and enable it to quickly take share from Medtronic.

Additionally, while Medtronic highlighted that its new smart programmer has a feature that allows a clinician to determine if a patient with an InterStim device is eligible for an MRI scan, it just tells if that patient is good for an MRI head scan, as the InterStim devices - all the InterStim II and some of the InterStim models - are eligible only for MRI examinations of the head.

Axonics, on the other hand, is going for full-body MRI labelling for r-SNM and is awaiting regulatory approval of this feature for its system.  

Medtronic told FirstWord MedTech that its smart programmer will only be offered to patients receiving a new or replacement implant. While this new feature might win over clinicians and patients, the medtech giant may have to do more - and soon - to hold on to its share of this market.   

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