In accusations of patent infringement, Medtronic is calling on the International Trade Commission and the U.S. District Court for the District of Delaware to block Axonics from importing and selling solutions that violate two of its patents related to MR compatibility for implanted medical devices.

The company says that Axonics, which develops sacral neuromodulation systems for adults with bladder and bowel dysfunction, designed a patient programmer with automated MR compatibility verification using its patented technology, and is calling on the ITC to investigate under section 337 of the Tariff Act of 1930, which allows for inquiries into whether imported goods infringe U.S. intellectual property rights and as a result, can be barred entry into the U.S.

The company already has a separate infringement suit against Axonics that is being evaluated in the U.S. District Court for the Central District of California in regard to four patents for Medtronic’s SNM technologies indicated for bowel and bladder conditions.
"The pattern is clear: Axonics uses Medtronic technologies to improperly compete in the market. It is time for Axonics to be held accountable for these unlawful acts,” said Mira Sahney, president of the pelvic health business in the neuroscience portfolio at Medtronic, in a statement.

In a statement of its own, Axonics accused Medtronic of trying to “stifle competition” and “limit patient and physician choice” to protect its top position in the market. It says that Medtronic used this position as a reason for not developing full-body MR-compatible SNM devices or increasing public awareness about advanced therapies for people with incontinence.

“Axonics took a different path and created a renaissance in sacral neuromodulation therapy by developing long-lived implantable devices and introducing full-body MR compatibility in this category for the first time. Axonics refuses to be intimidated by Medtronic and intends to defend itself vigorously,” said Raymond Cohen, Axonics’ chief executive officer, in its statement.

SNM solutions provide guideline-recommended therapies to treat overactive bladder, urinary retention, and fecal incontinence. The Axonics System is a miniature, long-lasting rechargeable neurostimulator that can provide therapy for up to 15 years, reducing the number of replacement devices and surgeries a patient needs. Its products include the Axonics R20 and F15 Systems, which have significantly improved patients' quality of life according to clinical studies, with no serious device-related adverse events reported.

Its fourth-generation R20 neurostimulator received FDA clearance in January 2023 and has a battery life of over 20 years. Other products like the Bulkamid Urethral Bulking System are expected to expand the treatment options for urinary incontinence.

Axonics, which is based in Irvine, California, announced in January that it is being acquired by Boston Scientific for $3.7 billion. The deal will mark Boston Scientific’s entrance into the sacral neuromodulation therapy market and is expected to close in the first half of 2024.

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