Tag: sacral neuromodulation
Axonics receives CE-mark approval for fourth-generation rechargeable SNM therapy
Axonics has announced that the Axonics R20 rechargeable sacral neuromodulation (SNM) system has received CE-mark approval.
Axonics expects to commence sales of the R20 to...
Medtronic files complaint against Axonics to stop “unauthorised use” of neuromodulation...
Medtronic recently announced that it has filed a complaint with the US International Trade Commission (ITC), along with a parallel action in US District...
Axonics announces definitive agreement to be acquired by Boston Scientific
Axonics has announced that it has entered into a definitive agreement to be acquired by Boston Scientific Corporation for US$71 in cash per share,...
Neuspera completes patient enrolment and implants for SANS-UUI pivotal clinical trial
Neuspera Medical recently announced it has completed patient enrolment and implant procedures for the SANS-UUI pivotal clinical trial of its Neuspera system—a discreet, minimally...
Office-based removal of sacral neuromodulation devices deemed safe and well-tolerated
As per a recently published retrospective chart review, the removal of sacral neuromodulation (SNM) devices in the office setting, under local anaesthesia, is a...
Axonics receives US FDA approval for fourth-generation rechargeable sacral neuromodulation system
Axonics has announced that the US Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation (SNM) system—a technology intended to provide...
Axonics gains Health Canada approval for fourth-generation rechargeable sacral neuromodulation system
Axonics has announced that Health Canada has approved the company’s fourth-generation rechargeable sacral neuromodulation system as a treatment for bladder and bowel dysfunction.
The newly...
Neuspera announces first successful Nuvella system implant in second phase of...
Neuspera Medical has announced the first patient has been successfully implanted with the Nuvella system in its pivotal SANS-UUI clinical trial, which will evaluate...
Axonics announces first patient implants in Canada with recharge-free sacral neuromodulation...
Axonics has announced the first patient implants in Canada with Axonics F15, the company’s newly developed, long-lived, fully recharge-free sacral neuromodulation (SNM) system.
The University...
Neuspera Medical announces second phase of SANS-UUI clinical trial with Nuvella...
Neuspera Medical recently announced it will begin enrolment in its pivotal clinical trial, SANS-UUI—a single-arm investigational device exemption (IDE) study that will enrol 145 patients...
Axonics announces comprehensive launch of F15 recharge-free SNM system
Axonics today announced the comprehensive launch of the Axonics F15 across the USA. The newly developed, long-lived, fully recharge-free sacral neuromodulation (SNM) system also...
Axonics receives FDA approval for new recharge-free sacral neuromodulation system
Axonics has announced that the US Food and Drug Administration (FDA) has approved its newly developed, long-lived, recharge-free sacral neuromodulation (SNM) implantable neurostimulator, the...
Medtronic receives FDA approval for InterStim X system for bladder and...
Medtronic has announced receipt of approval from the US Food and Drug Administration (FDA) for its new, recharge-free InterStim system—with the device being made...
Medtronic announces US launch of its InterStim Micro neurostimulator
Medtronic has announced that its recently US Food and Drug Administration (FDA)-approved InterStim Micro neurostimulator for sacral neuromodulation (SNM) therapy is now available in...
Axonics announces two-year results from its ARTISAN-SNM study
Two-year results of Axonics’ ARTISAN-sacral neuromodulation (SNM) study demonstrate that patients implanted with the r-SNM system continue to receive clinically meaningful and statistically significant...
Axonics receives FDA approval for 3T full-body MRI scans
Axonics, a company that has developed and is commercialising novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has...
FDA approval for Axonics’ wireless patient Remote Control with SmartMRI technology
Axonics, a company that has developed implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has announced US Food and...
Axonics wins FDA approval for its next-generation implantable neurostimulator
Axonics has announced the US Food and Drug Administration (FDA) approval of its next-generation rechargeable implantable neurostimulator for its r-SNM system under a premarket approval...
FDA approval of Axonics’ enhanced neurostimulator programmer
Axonics announces US Food and Drug Administration (FDA) approval of an enhanced, second-generation programmer for its r-SNM system under a premarket approval (PMA) application...
Medtronic receives CE mark for InterStim Micro Neurostimulator and InterStim SureScan...
Medtronic has announced it has received CE mark for its InterStim Micro neurostimulator and InterStim SureScan MRI leads—clearing the technologies for commercial sale and...
