InterStim Micro Neurostimulator and SureScan MRI Leads Cleared in Europe for Incontinence Control

Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obs...
Source: Medgadget - Category: Medical Devices Authors: Tags: Neurology Neurosurgery Radiology Rehab Source Type: blogs

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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'sÂ&...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
For 22 years, the world's largest pure-play medical device company was the only player in sacral neuromodulation, a space that addresses urinary problems as well as fecal incontinence. Now there's a new kid on the block, which has created quite an intense David vs. Goliath medtech story. For those unfamiliar with the Axonics vs. Medtronic story up to this point, click here for a quick rundown of recent events that have transpired in this market.   FDA Approves Second Indication for Axonics r-SNM FDA approved the urinary indications for an implantable rechargeable sacral neuro...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Implants Source Type: news
The medical device industry has seen its share of David vs. Goliath stories over the years, but few have been as intense as the battle between Medtronic and Axonics over the sacral neuromodulation (SNM) market. The story took an unexpected turn this week as Medtronic slapped Axonics with a patent infringement lawsuit that is likely to take years to play out. Medtronic (the Goliath of this story), filed a lawsuit against Axonics Modulation Technologies (the David of the story), alleging infringement of four patents related to Medtronic's SNM lead placement procedure and implant recharging technologie...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Implants Source Type: news
Medtronic has filed for FDA approval for its InterStim Micro neurostimulator and the accompanying InterStim SureScan MRI leads. The rechargeable device delivers sacral neuromodulation therapy to treat conditions such as overactive bladder, fecal inco...
Source: Medgadget - Category: Medical Devices Authors: Tags: Neurology Neurosurgery Radiology Rehab Source Type: blogs
Medtronic and Axonics are getting ready to square off in sacral neuromodulation, a fast-growing market that was monopolized by Medtronic until a month ago. Last month, Axonics won FDA approval to market its implantable rechargeable sacral neuromodulation (r-SNM) device for the treatment of fecal incontinence, and the company is expected to get FDA approval for overactive bladder and urinary retention any time now. The fecal incontinence approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted. Medtron...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
This study also found that Proteus DNA, a genus with many uropathogenic species (Drzewiecka, 2016), was more prevalent in women with OAB compared to asymptomatic controls (Curtiss et al., 2017). IC A recent study by Abernethy et al. suggested that the microbiome may play a role in IC (Abernethy et al., 2017). In this study, 16S rRNA analysis determined the microbiome of catheterized urine from women (n = 40) with IC was not dominated by a single genus and was less likely to contain Lactobacillus compared to asymptomatic women. Abernethy et al. also showed that L. acidophilus was associated with less severe scores on the ...
Source: Frontiers in cellular and infection microbiology - Category: Microbiology Source Type: research
Implanting a medical device often means giving up the opportunity to receive MRI scans in the future. This can be particularly true of complex electronic implants that may be negatively influenced by strong magnetic fields. Things are changing, thoug...
Source: Medgadget - Category: Medical Devices Authors: Tags: Neurosurgery Ob/Gyn Urology Source Type: blogs
This study was performed to assess the functional outcome after nerve‐sparing sacrocolpopexy Material and methodsFrom 2014 to 2016 all women undergoing a laparoscopic sacrocolpopexy for apical or multi‐compartment prolapse stage>2 were included in this prospective study. Laparoscopic sacrocolpopexy was performed utilizing the nerve‐sparing approach. Objective outcome was assessed by pre‐and post‐operative POP‐Q changes. De‐novo bladder and de‐novo bowel dysfunction were subjectively and objectively evaluated Results137 women were included. Significant objective improvement for point Aa and C (p
Source: Acta Obstetricia et Gynecologica Scandinavica - Category: OBGYN Authors: Tags: Original Research Article Source Type: research
AbstractA 4-year-old boy was referred to the nephrologist with daytime urinary incontinence and suspicion of an overactive bladder. At the age of 17  months he had been referred to the pediatric endocrinologist because of polyuria and polydipsia in order to exclude diabetes insipidus. Repeated water deprivation tests and a magnetic resonance imaging scan of the brain were normal. Diabetes insipidus was excluded, and primary polydipsia was thoug ht to be most likely since diabetes mellitus also had been excluded. At the current presentation, he drank up to 3 L a day and quite often had wet diapers. He also seemed ...
Source: Pediatric Nephrology - Category: Urology & Nephrology Source Type: research
StimGuard said it won another FDA Investigational Device Exemption to run a clinical trial of its percutaneously implantable device to treat urgency urinary incontinence as a result of refractory overactive bladder syndrome. The StimGuard device utilizes a 1.3mm microchip neurostimulator designed to be implanted non-surgically with a needle. The stimulator communicates with a small external transmitter that can be worn discretely and requires no physical contact with the skin. “If successfully trialed, the StimGuard technology would allow neuromodulation to be offered to patients in an office setting, which has never...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Urology StimGuard Source Type: news
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