First 3rd generation Axonics INS implanted in California.

First 3rd generation Axonics INS implanted in California.

The first 3rd generation Axonics INS was recently implanted at Sansum Clinic. The patient also will be participating in the ARTISTRY registry which will continue to build existing data about the Axonics SNM experience. The 2-program remote will allow for more therapy options remotely and provide a broader range of Amplitude.

With the 2nd generation INS patients have only 1 program and a limit to the upward amplitude thus necessitating in person reprogramming if efficacy fades with nerve fatigue/habituation or worsening baseline condition. With the older INS, I typically set the patients at L2 with a larger step size to make their Amplitude ceiling higher. Since the Axonics connectivity is excellent and highly accessible given the key fob design patients can sometime over connect and increase their stimulation too much.

This is a very different issue to manage compared to the MDT remotes which have terrible connectivity and poor functionality with 2 bulky complicated items both needing to be charged (Anecdotally confirmed at my clinic, noted high prevalence of MDT remote issues in the FDA Maude database and recently re-reviewed here: “Identifying Opportunities to Improve Patient Experience With Sacral Neuromodulation: A Human Factors Approach”).

To ensure that my patients are managing their Axonics devices well, I offer visits with the Axonics support team the 1st Wednesday of the month for any troubleshooting on recharge or remote use in addition to resetting the 1 program remote if maxed out and/or regression of symptoms is reported. Patients need to be reminded that they may not have 100% efficacy and constantly connecting and increasing the Amplitude will create further management issues requiring more office visits. I am hopeful that the 2-program option will negate some of these fussy problems, reduce the burden on SNM patients and make sure patients are receiving sustained efficacy after a successful SNM trial SNM.

Currently, 70% of my Axonics patients tested with a PNE procedure (~60% conversion) or surgical tined lead (~75% conversion) subsequently end up with a full implant. This lower conversion rate reflects my SNM patient population with is usually desperate with severe symptoms and/or they have highly refractory symptoms often having failed several prior therapies. Even with excellent PNE wires and/or surgical lead placement I need patients to report subjective improvement that reflects a significant improvement in QoL (often not just 50% objective improvement).

A follow-up phone survey of 25% of my Axonics implant patients revealed that 13% were very much better, with 73% better and 13% similar. In regards to frequency of charging and duration of charging, 33% find it very acceptable with 53% reporting it as acceptable and 13% stating a neutral. 53% charge weekly, 20% every 2 weeks, 13% every 3 weeks and 13% monthly. Overall, 20% were very satisfied, 60% were satisfied and 20% were neutral with their Axonics therapy. I hope we can obtain more very satisfied patients once the primary cell device (recent alliance with Micro System Technologies) is available which will reduce patient management to simply the key-fob remote.

The incontinence space continues to change rapidly with Medtronic SNM implants matching Axonics MRI conditional status with their expanded MRI labeling announced in February. Axonics still offers more ease with MRI scans given the ability of the MRI tech to manage the key-fob remote prior to imaging. It was exciting to see Axonics recently acquire Bulkamid given the excellent performance of this SUI therapy in my clinic! I agree that this addition will expand SNM awareness given the number of surgeons restricted by the FDA warning on urethral mesh slings and the very strong desire of patients to be offered minimally invasive procedures with very low risk. I believe we will greatly serve more women with Mixed urinary incontinence by combining the attributes of Bulkamid with the inherent restorative nature of neuromodulation.

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