An Ugly Patent Battle Brews Behind The Scenes In Sacral Neuromodulation
In November 2019, Medtronic slapped Axonics with a patent infringement lawsuit that is likely to take years to play out.
The lawsuit originally alleged that Axonics infringed four patents related to Medtronic’s sacral neuromodulation lead placement procedure and implant recharging technologies. A couple weeks later, Medtronic added three additional patent infringement claims to its complaint against Axonics. The suit was filed in the United States District Court for the Central District of California and seeks the typical remedies for patent infringement, including damages and an injunction.
“Medtronic believes competition drives innovation and broader market awareness, which is good for the industry and for patients, and we welcome competitors who play by the rules and existing laws,” Medtronic said in a statement e-mailed to MD+DI last November. “We are also committed to protecting our proprietary technology and intellectual property, which drives our continued innovation. We believe these additional claims further confirm the merits of our complaint.”
In response, Axonics is contesting the validity of each patent Medtronic has accused it of infringing. The company filed seven petitions with the U.S. Patent and Trademark Office requesting an inter partes review of each of the Medtronic patents in question.
Medtronic Interstim Center Of Excellence
Oxford Urology Associates is extremely proud to announce that Dr. Land Renfroes Medtronic InterStim program has been officially designated as an InterStim Center of Excellence . The COE recognizes physicians who demonstrate exemplary use of the InterStim System and a commitment to patient care for those suffering from symptoms associated with Overactive Bladder, Fecal Incontinence and Non-Obstructive Urinary Retention.
The Medtronic COE program is designed to help patients find experienced physicians who show exemplary care with the InterStim system while also recognizing physicians for their exemplary care.
Who Should Consider Medtronic Bladder Control Therapy Delivered By The Interstim System
Medtronic Bladder Control Therapy delivered by the InterStim System may be an option for patients with overactive bladder and non-obstructive urinary retention. Patients should consider Medtronic Bladder Control Therapy after they have tried other treatments such as fluid and diet modifications, medications and behavioral therapy and they have not worked successfully or could not be tolerated.*
Medtronic Bowel Control Therapy for the treatment of chronic bowel incontinence should be considered after patients with bowel control problems have tried other treatments such as medications and dietary modifications and they have not worked, or were not a candidate for these treatments.
The InterStim System does not treat every type of bladder control or bowel control problem. For more information, please visit: www.medtronic.com
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How The Device Works
Once you and your provider decide that Medtronic Bladder Control Therapy is the right option for you, your board-certified urologist at Urology Care P. C. will implant the InterStim neurostimulator in your lower back near your sacral nerves. Since the sacral nerves control urinary function, sending electrical pulses to the sacral nerves can help send signals to your brain to control the muscles involved in urinary function.
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Candidates For Medtronic Bladder Control Therapy
Anyone who has not responded well to traditional conservative treatments is a candidate for Medtronic Bladder Control Therapy. During an initial examination, you and your provider will discuss your health history and your response to other treatments. You will be able to engage in a trial period using a trial lead that will be inserted into your lower back at the site of your sacral nerves. The neurostimulator will be external during your trial period.
If the trial period is a success, then you will be able to effectively decide whether or not the long-term commitment to Medtronic Bladder Control Therapy is the right choice for you.
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Interstim Therapy Trial Period
InterStim II and InterStim Micro offer a trial device that simulates the actual, implanted device. This is called InterStim Stage 1. Receiving the trial device is a 15-minute, minimally invasive outpatient procedure where the doctor places a lead connected to a small, externally worn device. The external device is worn underneath the patients clothing.
Patients typically wear the trial device between 5-14 days to determine candidacy for a permanent device. During this time, patients log their symptoms to discuss with their doctors. They can continue about their normal activities and experience what it would be like to live with InterStim therapy, how it feels when activated, and if the permanent device will be able to reduce or eliminate their symptoms.
How Does Interstim Micro Compare In Size To Other Neurostimulators
The InterStim Micro neurostimulator is about half the size of the other rechargeable device on the market.
The most common adverse events include pain at implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations. Any of these may require additional surgery or cause return of symptoms.
Visit Medtronic.com to learn more.
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Will The Evaluation Cure My Condition
No. The evaluation is temporary. It is a tool that helps determine whether Medtronic Bladder Control Therapy is appropriate for you. Once the wire is removed, your original symptoms will return. If you have positive results with the evaluation, then you and your doctor may decide to use long-term neurostimulation to treat your symptoms.
Will My Everyday Activities Be Affected During The Evaluation
You should take it easy during the evaluation. Avoid bending, stretching, or lifting heavy objects. You can usually continue to work throughout your evaluation if your job doesnt require strenuous movement. Be aware that the evaluation wire can move. Keep your activity level low to moderate and please discuss this with your health care professional.
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Interstim Bladder Control Therapy In Covington La
The highly trained urologists at Louisiana Healthcare Associates have extensive experience using the InterStim system to treat patients for OAB and urinary incontinence. They will take the time to fully explain the procedure and answer any questions you may have. If you have more questions or think the InterStim system may be right for you, call our office in Covington, LA at today!
Q: Why Is This Therapy Different From Other Options
A: You can try it before you decide, and its reversible if you change your mind later. The InterStim II system is clinically superior to oral medication and the InterStim Micro system is designed to deliver the same results.,5 And unlike injections, this therapy doesnt require self-catheterization or repeated treatment visits.
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Could I Have Overactive Bladder
If youve found that your bladder is controlling you more than youre controlling it, you could have a medical condition called Overactive Bladder, or OAB. And despite what you may have heard, its not an inevitable part of the aging process, and its not something you should just have to live with.
Fortunately, there are real, effective treatments available. The first step on your path to better wellness begins with understanding the signs and symptoms:
Medtronic Bladder Control Therapy Delivered By The Interstim Systems
- Also known as sacral neuromodulation
- Targets the sacral nerve in the lower back
- Uses a handheld smart programmer
- Implantable device
- Allows full-body MRI scans when using the SureScan lead*
- Used to treat the symptoms of overactive bladder and non-obstructive urinary retention
- Deliver SNM therapy that has been shown to be more effective than medications for OAB,1
- Ideal for people who can tolerate surgery
- Offers a test run evaluation that lasts 3 to 14 days
- Recharge-free and rechargeable options let you choose the right device for your lifestyle
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Risks Of Medtronic Bladder Control Therapy
As with any surgical procedure, implanting an InterStim system has risks. You may experience swelling, bruising, bleeding, infection or irritation, and discomfort with the mild electrical impulses.
Medtronic Bladder Control Therapy is not the right choice for everyone. If there are any complications throughout the course of your treatment, you should make an appointment with your provider at Urology Care P.C.
When overactive bladder disrupts your quality of life, our team at Urology Care P.C. is here to provide you with high-quality, personalized care to ensure your long-term health. Our expert providers will provide you with an accurate diagnosis and a personalized comprehensive treatment plan.
To determine what treatment is needed for you, contact us at to schedule your appointment.
Ecoin From Valencia Technologies
Finally, theres the eCoin. Like RENOVA and the StimRouter, the nickel-size device must be implanted in an outpatient procedure.
But unlike other devices, the eCoin is entirely self-contained. Its programmed by a clinician before it goes in to the lower leg, then it automatically provides stimulation at regular intervals so you dont have to think about it.
One drawback is that the battery inside the device must be replaced every three to five years. For anyone who doesnt want to worry about treatment schedules, though, that replacement just might be worth it.
The eCoin is currently recruiting patients for a trial of the device, and results are expected in early 2020.
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Your Bowel Control Matters
Fecal incontinence is more common than you think and affects 4.8-6.7% of adults.3
It is possible you can suffer from both bladder and bowel problems.5
17% of adults suffer from OAB in Europe.4 18%of patients with OAB may also have fecal incontinence6.
Even if the journey can be long, solutions are available, and each patient may be offered suitable therapies according to his/her symptoms. If there is an underlying cause to the symptoms, this should be treated first.
First line treatments should be proposed by your doctor:
- Behavioural treatments: lifestyle changes, fluid and diet modifications, bowel retraining, pelvic floor exercises/physical therapy
- Medication: Your doctor may prescribe medications to help control the symptoms
If these treatments are not working or not well tolerated, other specialised options can be offered.
Medtronic Receives Fda Approval For Interstim X System The Next Generation Of The Most Personalized Sacral Nerve Stimulation Therapy For Bladder And Bowel Control
Medtronic plc , a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration for InterStim X the next generation…
DUBLIN, Feb. 22, 2022 /PRNewswire/ — Medtronic plc , a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration for InterStim X the next generation of the InterStim portfolio’s recharge-free device and it is available immediately. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation therapy. Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim Micro device. Both devices are used in the treatment of overactive bladder , chronic fecal incontinence , and non-obstructive urinary retention.
The InterStim X device features:
- Proprietary 5th generation battery chemistry that offers more than 10 years of battery life without the need to recharge, providing patients with more freedom and less maintenance. With low energy settings, the device may last up to 15 years.
The InterStim Micro device features:
Both systems feature:
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Talk To Someone Who Understands
Connect with people who have experienced life-changing relief with Medtronic bladder control therapy.
In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, lead movement/migration, device problems, undesirable changes in urinary or bowel function, and uncomfortable stimulation . Talk with your doctor about ways to minimize these risks.
Most common side effects of PTNM are temporary and include mild pain or skin inflammation at or near the stimulation site.
Under certain conditions see approved labeling for details.
Siegel S, Noblett K, Mangel J, et al. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim® therapy compared to standard medical therapy at six months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. 2015 34:224230.
Peters, K. M., S. A. Macdiarmid, et al. . Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol 182: 10551061.
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
How Does Interstim Therapy Work
InterStim therapy works by stimulating the sacral nerves with tiny electrical pulses. In individuals experiencing urinary or fecal incontinence, the brain and the sacral nerves are unable to communicate properly. InterStim therapy attempts to better regulate the sacral nerves function, so the nerves can interpret signals from the brain and pass them on to the surrounding pelvic floor muscles. Mild electrical pulses help the nerves to function normally, much in the same way that a pacemaker uses electrical impulses to keep the heart beating on a steady, predictable rhythm. This restores normal bladder and bowel function.
As a result of the pulses from InterStim devices, the symptoms of an overactive bladder or bowel incontinence are effectively eliminated.
These devices are an option for patients who have not responded to more conservative treatments such as changes to diet, medication and physical therapy.
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Oab Causes A Frequent Urgent Need To Urinate
When Victor Nitti, MD, the division chief of pelvic medicine at UCLA Health in Los Angeles, began practicing urology in 1992, people with overactive bladder didnt have a lot of options for treatment.
We were really short on effective therapies, Dr. Nitti says. The term overactive bladder wasnt even coined until 2002.
Fortunately, science has come a long way since then. Today, people who experience the hallmark symptoms of OAB frequent and almost irresistible urges to urinate have a lot of choices. Behavioral therapies and medications are starting points, but if neither of those approaches work, doctors can prescribe a device to help manage the problem.
A good number of patients dont respond to counseling or medication, Nitti says. But that doesnt mean their OAB cant be treated. Theres a large number of patients out there who are excellent candidates for device-based treatment.
Here are five devices in development right now that may help you manage the urge to go.
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Restored bladder function is defined as a measurable reduction in urinary frequency and/or urinary incontinence episodes following PTNM treatment.
Gray S, Anderson M, Dublin S et al. Cumulative Use of Strong Anticholinergics and Incident Dementia. JAMA Intern Med. 2015 175:401-407.
Yeaw J, Benner J, Walt JG et al. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009:15:724-736.
Siegel S, Noblett K, Mangel J, et al. Five-Year Follow-up Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation. The Journal of Urology 2018 Volume 199, 229236.
Medtronic InterStim Therapy Clinical Data Summary .
Kobashi K, Nitti V, Margolis E, et al. A prospective study to evaluate efficacy using the NURO percutaneous neuromodulation system in drug naive patients with overactive bladder syndrome. Urology 2019 131:7782.
van der Pal, F., M. R. van Balken, et al. . Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? BJU Int. 97:547550.
Yoong, W., P. Shah, et al. . Sustained effectiveness of percutaneous tibial nerve stimulation for overactive bladder syndrome: 2-year follow-up of positive responders. Int Urogynecol J. 24:795799.
Bladder Control Therapy In Bradenton Fl
Allison Wyman, MD is an expert urogynecologist committed to providing the highest quality care to patients throughout the Bradenton and Sarasota area in the diagnosis and treatment options for women suffering from overactive bladder. Dr. Wyman is dedicated to offering patients a wide range of quality urogynecology services in a warm and friendly environment to provide the very best care.
As a board-certified and expert-trained surgeon, Dr. Wyman is experienced in offering the latest technology in treating overactive bladder, including the most minimally invasive surgical procedures. Our practice services a wide variety of patients from all over the state of Florida at our office in Bradenton seeking state-of-the-art care in urogynecology with a personal touch to improve their outcomes.
Bladder Control Therapy Delivered By Neuromodulation
COMMUNICATION IS CRITICAL
Evidence suggests that breakdowns in the bladder-brain communication pathway are the root cause of OAB and non-obstructive urinary retention.1-3 While other therapies focus on the bladder muscles, Medtronic therapies target the nerves, which is thought to help restore normal bladder function.*
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Treatments For Overactive Bladder
There are lots of reasons why people dont seek treatment for OAB. Many people dont think that anything can be done about it. Some assume that its actually normal as they get older. And others are simply too embarrassed to talk about it. In fact, less than half of adults living with OAB seek help for their condition1.
Thats unfortunate, because theres a whole range of proven, effective treatments available, including some that you can do on your own, right now. Some of these options include:
Changes in Diet Acidic foods, spicy foods, sugar, caffeine and alcohol can all aggravate OAB symptoms. Some cause bladder irritation, others can increase your need to urinate, but they should all be monitored and limited.
Pelvic Floor Exercises Women who exercise the muscles in the pelvic floor can strengthen them enough to measurably improve their ability to control their bladders. Its easy to do, discreet and effective.
Bladder Retraining Scheduling bathroom visits, delaying urination and keeping a bladder diary can all help you manage and improve how frequently and urgently you need to urinate.
Medication Theres a wide range of medications, including over-the-counter and prescription oral medications as well as injectables that can help improve bladder function for many patients.
Neuromodulation A therapy that uses gentle nerve stimulation thought to normalize bladder-brain communication.
Medtronic Bladder Control Therapy Delivered by The InterStim System