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Medtronic Wins CE Mark for Rechargeable Sacral Neuromodulation Tech
Medtronic CEO Omar Ishrak talked about the company's latest regulatory milestone in sacral neuromodulation during his presentation Monday at the J.P. Morgan Healthcare Conference in San Francisco, CA.

Medtronic Wins CE Mark for Rechargeable Sacral Neuromodulation Tech

The regulatory milestone marks a significant gain in the company's ongoing battle for market share against newcomer Axonics.

The sacral neuromodulation market continues to see disruption as Medtronic scores a CE mark for its InterStim Micro neurostimulator and InterStim SureScan MRI leads, clearing the technologies for sale in Europe.

InterStim Micro is a rechargeable device that delivers sacral neuromodulation (SNM) therapy to treat overactive bladder (OAB), fecal incontinence (FI) and non-obstructive urinary retention. It is 80% smaller than the existing recharge-free InterStim II neurostimulator and could reduce the need for battery replacement surgeries due to its life of 15 years. It also features Medtronic's Overdrive battery technology — a battery with virtually no loss in capacity over time — that provides simple and rapid recharging, according to the company. The SureScan leads, which will be used in both the InterStim Micro system and in future implants of the recharge-free InterStim II, are designed to allow for full-body 1.5 and 3 Tesla MRI-conditional scans.

“We’re excited our most recent technology advances in sacral neuromodulation will allow physicians to treat more patients who need relief from their symptoms,” said Brooke Story, vice president and general manager of the Medtronic's pelvic health and gastric therapies business, which is part of the company's restorative therapies group. “We pioneered this therapy 25 years ago in partnership with physicians, and we have the only five-year data for all indications to demonstrate its safety and efficacy. We know from deep experience that it’s important the therapy accommodates the lifestyle of the patient to produce the best outcome, and our latest innovations will now offer them a lifestyle-friendly choice in Medtronic SNM systems.”

The SNM market has seen quite a bit of activity in recent months as Irvine, CA-based Axonics Modulation Technologies has challenged Dublin, Ireland-based Medtronic for market share.

Axonics brought its rechargable SNM system to the European market a few years ago and picked up traction in the space last year after its CE mark was expanded to include 1.5T and 3T full-body MRI conditional labeling. The two companies really started going toe-to-toe in the latter part of the 2019 as Axonics gained FDA approval to sell the Axonics r-SNM system in the United States. Medtronic filed a patent infringement lawsuit against Axonics in November. The lawsuit hasn't slowed Axonics down any though, and the company was voted 2019 Medtech Company of the Year by MD+DI readers.

Medtronic's new CE mark does mean, however, that it is the only company in Europe to offer patients a choice between rechargeable and recharge-free systems that are both full-body MRI-conditional. The company is also in the process of bringing the rechargeable version of the technology to the U.S. market.

Medtronic CEO Omar Ishrak talked about the significance of that choice Monday during his presentation at the J.P. Morgan Healthcare Conference in San Francisco, CA. While the company is excited about offering the smaller rechargeable device, Ishrak said there is also a pool of patients who will still use the larger recharge-free device, which will now have full 3T full body MRI compatibility.

"This market is going to break up into patients who will put up with recharging and patients who will want a primary cell device with no need for recharging, and we will have both of those areas covered with new products which will be leading edge in this marketplace," Ishrak said.

Competitiveness aside, more options and increased marketing efforts by both companies is expected to increase awareness of SNM and expand the market.

"Effective long-term bladder and bowel control is an under-met medical need for many who experience regular accidents and/or frequency issues associated with OAB and FI," said Philip E.V. Van Kerrebroeck, MD, PhD, a professor of urology at Maastricht University Medical Centre, in Maastricht, the Netherlands. "The new capabilities offered by MRI-conditional InterStim II and InterStim Micro will give patients the ability to choose a system that is compatible with their lifestyle, and they can have an MRI without being explanted. I’m excited because it allows me to offer the trusted experience and support of Medtronic to help give my patients their lives back.”

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