Tuesday, June 18, 2024

Overactive Bladder Treatment: Axonics F15 SNM System Approved by Australia’s TGA

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The Axonics F15 SNM System, designed to treat adults with overactive bladder and representing a significant innovation in neuromodulation therapy, has received approval from Australia’s Therapeutic Goods Administration (TGA), as announced by medical technology company Axonics. The Axonics F15 SNM system includes a small and thin implantable neurostimulator (INS), which has a volume of just 10cm³, making it less intrusive for patients.

One of the standout features of the F15 system is its primary cell battery, which boasts an expected lifespan of over 15 years at typical stimulation parameters. For patients who require lower settings, the battery can potentially last more than 20 years. This long battery life reduces the need for frequent replacements, providing significant convenience and peace of mind for overactive bladder patients.

The device also offers constant current stimulation, a capability that allows for automatic adjustments to maintain symptom relief with minimal reprogramming. This feature ensures consistent and effective treatment, adapting to the overactive bladder patient’s needs over time without requiring frequent clinical visits for reprogramming.

Axonics CEO Raymond W. Cohen emphasized the company’s dedication to innovation and patient care. He stated, “Our mission-driven team remains committed to innovating, supporting our dedicated physician customers and their patients, and raising awareness of our best-in-class incontinence therapies in the United States, Europe, and Australia.” This statement underscores Axonics’ focus on delivering cutting-edge medical solutions and expanding the reach of their therapies to a global audience.

MRI-Compatible and Recharge-Free, Enhancing Overactive Bladder Treatment

The F15 system is MRI-compatible with both 1.5T and 3.0T whole-body MRI scanners, ensuring that overactive bladder patients can undergo necessary imaging procedures without compromising the functionality of their neuromodulation device. Additionally, the system features an intuitive, easy-to-use recharge-free patient remote control, enhancing the overall patient experience by simplifying device management.

Calvary North Adelaide Hospital urologist Dr. Ailsa Wilson Edwards expressed enthusiasm for the new device, stating, “I am excited to offer my patients a recharge-free option that significantly increases device longevity compared to legacy technology, provides constant current stimulation, and utilizes a simple remote control that is recharge-free and easy for patients to use.” Dr. Edwards’ endorsement highlights the clinical benefits and improved patient convenience associated with the Axonics F15 system.

Earlier this year, Boston Scientific agreed to acquire Axonics in a deal valued at approximately $3.7 billion, aimed at expanding its urology portfolio. This strategic acquisition underscores the value and potential of Axonics’ innovative products in the broader medical technology market.

Overactive Bladder

Axonics Advances Overactive Bladder Treatment with Comprehensive Neuromodulation Solutions

In addition to the F15 system, Axonics offers other products designed to treat urinary and bowel dysfunction. These include the R20 system, which also delivers sacral neuromodulation therapy, and the Bulkamid urethral bulking system, which is used to treat female stress urinary incontinence. These complementary products demonstrate Axonics’ comprehensive approach to addressing various aspects of urinary and bowel dysfunction, providing a range of solutions tailored to different patient needs.

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Axonics is deeply focused on developing and commercializing devices that improve the quality of life for patients with urinary and bowel dysfunction. Their innovative approach and commitment to patient care have positioned them as a leader in the field, continuously advancing the technology and effectiveness of neuromodulation therapies.

The approval of the Axonics F15 SNM system by Australia’s TGA represents a significant milestone for the company and offers new hope for patients with overactive bladder. With its long-lasting battery, MRI compatibility, and user-friendly features, the F15 system is poised to set a new standard in sacral neuromodulation therapy. Axonics’ dedication to innovation and patient-centered care continues to drive its success and impact in the medical technology industry.


Resource: Therapeutic Goods Administration, May 16, 2024

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