Competitive Technologies
Why implanted neurostimulators?
Symptoms of Overactive Bladder (OAB) include urge incontinence, frequent voiding, incomplete voiding, nocturia, inability to void among others (see ICD-10 codes under Treatment Algorithm), and affect approximately 16 million American adults. Despite the optimal use of conservative treatment methods, symptoms of OAB often remain a therapeutic problem, including drug therapy, behavioural therapy, pelvic floor exercises and biofeedback. Anticholinergic (drug) therapy is the first therapeutic attempt to reduce symptoms of OAB, but is limited by side-effects or if the therapeutic goal is not achieved. Side effects include dry mouth, blurred vision, constipation, urinary retention, tachycardia (increased heart rate), confusion, memory impairment, drowsiness, and others. Once side effects limit the practicality of a drug based therapy, treatments using neuromodulation provide an effective treatment alternative with a well established efficacy in scientific and medical literature.
Current FDA-Approved Neurostimulation Options
Overview
There are two anatomical locations in the human body that have received FDA approval / clearance to utilize electrical nerve stimulation (neurostimulation) in the body to treat Overactive Bladder (OAB) or Neurogenic Bladder (NB).
| Location | Tibial Nerve | Sacral Nerves | |||
|---|---|---|---|---|---|
| Name | Altaviva | eCoin | Revi | Interstim & Interstim Micro | Axonics System |
| Manufacturer | Medtronic | Valencia Technologies | Bluewind Medical | Medtronic | Axonics / Boston Scientific |
| Reimbursement code | 0816T | Trial: 64561 -50 Perm: 64561 |
|||
| Reimbursement rate* | Outpatient $21,063 and ASC $19,464 | Trial: $6,563 Perm: $21,444 |
|||
| Trial implant Procedure | No trial before implanting a permanently placed implant. | Needle injection of a trial lead wire that sticks out of the body for 7-10 days typically. | |||
| Permanent implant Procedure | Surgery involving incisions approximately 1-1.5 inch long on the ankle (see details below). | Surgery involving incisions approximately 1-1.5 inch long on the lower back (see details below). | |||
| Battery? | yes | yes | no | yes | yes |
*The reimbursement information, including CPT®, HCPCS, and CMS codes, coverage levels, and related policies, is provided for general informational purposes only. While we have made efforts to compile accurate information from publicly available sources (including CMS, FDA, and medical device manufacturer websites), coding, coverage, and payment policies are subject to change without notice. This information does not constitute legal, financial, billing, or reimbursement advice. Users are responsible for verifying coding, coverage, and payment information with the appropriate payers and should consult with their own reimbursement, compliance, or legal advisors regarding any specific questions. We make no representation, warranty, or guarantee that use of the information provided will result in coverage or payment.
Tibial Nerve Stimulation
Medtronic Altaviva System
Courtesy of the FDA: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240011
| Product Name: | Altaviva System |
|---|---|
| Generic Name: | Stimulator, tibial, electrical, implantable, for urinary incontinence |
| Applicant: | Medtronic Neuromodulation 7000 Central Ave., N.E. MS RCE480 Minneapolis, MN 55432 |
| PMA Number: | P240011 |
| Date Received: | 04/04/2024 |
| Decision Date: | 09/18/2025 |
| Product Code: | QPT |
| Advisory Committee: | Gastroenterology/Urology |
| Clinical Trials: | NCT05226286 |
| Battery: | Yes, rechargeable. 15 year lifespan. |
| Recharge duration: | 30 minutes |
| Approval Statement: | Approval for the Medtronic Altaviva System is indicated for treatment of urge urinary incontinence (UUI) in patients who failed or could not tolerate more conservative treatments. |
Additional info:
| Reimbursement: | 0816T - Outpatient $21,063 and ASC $19,464 |
|---|---|
| Surgery: | Requires ~3cm (1-1.5 inch) incision, then blunt dissection to form pocket for the stimulator intended to be implanted |
*The reimbursement information, including CPT®, HCPCS, and CMS codes, coverage levels, and related policies, is provided for general informational purposes only. While we have made efforts to compile accurate information from publicly available sources (including CMS, FDA, and medical device manufacturer websites), coding, coverage, and payment policies are subject to change without notice. This information does not constitute legal, financial, billing, or reimbursement advice. Users are responsible for verifying coding, coverage, and payment information with the appropriate payers and should consult with their own reimbursement, compliance, or legal advisors regarding any specific questions. We make no representation, warranty, or guarantee that use of the information provided will result in coverage or payment.
eCoin by Valencia Technologies
Courtesy of the FDA:
1) https://www.fda.gov/medical-devices/recently-approved-devices/ecoin-peripheral-neurostimulator-p200036
2) https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200036B.pdf#:~:text=Life%20and%20Elective%20elective%20replacement%20of%20the,when%20programmed%20at%20its%2015%20mA%20setting
3) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200036
| Product Name: | eCoin® Peripheral Neurostimulator |
|---|---|
| Generic Name: | Stimulator, tibial, electrical, implantable, for urinary incontinence |
| Applicant: | Valencia Technologies Corporation |
| Address: | 28464 Westinghouse Place, Valencia, CA 91355 |
| Approval Date: | March 1, 2022 |
| PMA Number: | P200036 |
| Date Received: | 08/10/2020 |
| Decision Date: | 03/01/2022 |
| Product Code: | QPT |
| Notice Date: | 03/08/2022 |
| Advisory Committee: | Gastroenterology/Urology |
| Clinical Trials: | NCT03556891 |
| Battery: | Yes, non-rechargeable primary cell. 1-8 year lifespan. |
Additional info:
| Reimbursement*: | 0816T - Outpatient $21,063 and ASC $19,464 |
|---|---|
| Surgery: | Requires ~3cm (1-1.5 inch) incision, then blunt dissection to form pocket for the stimulator intended to be implanted |
| Battery life: | ~1 year at 15mA setting and ~2 years at 6mA setting before replacement is required. Source: |
*The reimbursement information, including CPT®, HCPCS, and CMS codes, coverage levels, and related policies, is provided for general informational purposes only. While we have made efforts to compile accurate information from publicly available sources (including CMS, FDA, and medical device manufacturer websites), coding, coverage, and payment policies are subject to change without notice. This information does not constitute legal, financial, billing, or reimbursement advice. Users are responsible for verifying coding, coverage, and payment information with the appropriate payers and should consult with their own reimbursement, compliance, or legal advisors regarding any specific questions. We make no representation, warranty, or guarantee that use of the information provided will result in coverage or payment.
Treatment parameters:
| Amplitude Range | 0.5 to 15 mA |
|---|---|
| Frequency | 20 Hz |
| Pulse Width | 0.2 ms |
| Stimulation Output | Current Controlled |
| Treatment Duration | 30 Minutes |
| Treatment Interval | 3 days for the first 18 weeks (42 sessions) and every 4 days thereafter |
| Device life | Range: 1-8 years |
| Replacement after | ~1 year at 15 mA setting (max), or ~2 years at 6 mA setting, or ~3 years at "moderate amplitude" impacting Battery life |
Further information, courtesy of the FDA, content as of 03/18/2022:
What is it?
The eCoin Peripheral Neurostimulator System generates electrical pulses to help stimulate nerves related to bladder control in people with urgency urinary incontinence, or a sudden urge to urinate that causes some urine to leak out. The device is implanted under the skin near the ankle and is controlled by a healthcare provider using a remote control.
How does it work?
The eCoin Peripheral Neurostimulator System is implanted under the skin of the ankle to stimulate the tibial nerve, a nerve that allows feeling and movement to parts of the leg and foot. This nerve also has some influence over the nerves that control the bladder. Once implanted, the eCoin system delivers electrical pulses to the tibial nerve in 30-minute sessions based on a fixed schedule. A healthcare provider can adjust the level of stimulation based on each patient’s sensitivity and needs, using the remote control.
Nerves controlling the pelvic organs, including the bladder, originate from the lower spine and are connected to the tibial nerve in the leg, though it is not known exactly how neurostimulation of the tibial nerve helps stimulate the nerves controlling the bladder.
When is it used?
The eCoin Peripheral Neurostimulator System is intended for use in patients who have urgency urinary incontinence and who have not had success at treating their condition through behavior changes such as pelvic exercises, limiting fluid intake, scheduling times to urinate or through medications.
What will it accomplish?
In a clinical study, 68% of patients (90/132) with urgency urinary incontinence had a 50% or greater reduction in urgency urinary incontinence episodes up to 48 months after activating the eCoin Peripheral Neurostimulator System.
Valencia Technologies Corporation will also conduct a 5-year Post-Approval Study (PAS) to study real-world effectiveness of this system for treatment of urgency urinary incontinence. The study will also record any related adverse events of interest.
When should it not be used?
The eCoin Peripheral Neurostimulator System should not be used in people have:
A history of surgery in the implant area of the ankle
Previous, unhealed damage or infections near the implant area
Lower leg or foot conditions, including:
Open wounds or sores on the lower leg or foot
Swelling from excess fluid build-up in the lower leg
Vein or artery disease or insufficiency in the lower leg
Inflammation or skin conditions in the lower leg
Additionally, the system should not be used in patients who are unable to operate the device’s Patient Controller Magnet.
BlueWind Medical Revi system
Courtesy of the FDA: https:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240037
| Device Name: | Revi™ System |
|---|---|
| Device Classification: | Implanted Tibial Electrical Urinary Continence Device |
| Generic Name: | Stimulator, tibial, electrical, implantable, for urinary incontinence |
| Applicant: | BlueWind Medical Ltd. 6 Maskit Street Herzliya, IL 4614002 |
| 510(k) Number: | K240037 |
| Product Code: | QXM |
| Classification: | Class II |
| Date Received: | 01/05/2024 |
| Decision Date: | 05/02/2024 |
| Predicate Device: | DEN220073 (Revi System, 2023-08-16) |
| Decision: | Substantially Equivalent (SESE) |
| 510k Review Panel: | Gastroenterology/Urology |
| Type: | Traditional |
| Summary: | https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240037.pdf |
| Indications for use: | The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. |
Additional info:
| Reimbursement*: | 0816T - Outpatient $21,063 and ASC $19,464 |
|---|---|
| Surgery: | Requires ~3cm (1-1.5 inch) incision, then open dissection to the tibial nerve to be able to suture implant to the surrounding tissue using the anchoring openings provided in the silicone suture wings. |
| Battery: | No |
*The reimbursement information, including CPT®, HCPCS, and CMS codes, coverage levels, and related policies, is provided for general informational purposes only. While we have made efforts to compile accurate information from publicly available sources (including CMS, FDA, and medical device manufacturer websites), coding, coverage, and payment policies are subject to change without notice. This information does not constitute legal, financial, billing, or reimbursement advice. Users are responsible for verifying coding, coverage, and payment information with the appropriate payers and should consult with their own reimbursement, compliance, or legal advisors regarding any specific questions. We make no representation, warranty, or guarantee that use of the information provided will result in coverage or payment.
Treatment parameters:
| Amplitude Range | Up to 14 mA ±20% or ±0.15mA |
|---|---|
| Stim Waveform | Biphasic charge - neutral |
| Frequency | Up to 30 Hz ±10% |
| Pulse Width | Up to 0.79 ms ±10% |
| Operating frequency | The Revi System operates at 6.78 MHz, centered at the 6.765-6.795 MHz. |
| Treatment Duration | 30 Minutes to 2 hours, at the discretion of the clinician |
Sacral Nerve Stimulation
Medtronic InterStim, InterStim II and InterStim Micro System
Courtesy of the FDA:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p080025
| Product Name: | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL |
|---|---|
| Generic Name: | Stimulator, electrical, implantable, for incontinence |
| Applicant: | Medtronic Neuromodulation 7000 Central Ave., N.E. MS RCE480 Minneapolis, MN 55432 |
| PMA Number: | P970004 // P080025 |
| Date Received: | 01/30/1997 // 09/26/2008 |
| Decision Date: | 09/29/1997 // 03/14/2011 |
| Product Code: | EZW // QON |
| Advisory Committee: | Gastroenterology/Urology |
Additional info:
| Reimbursement*: | CMS 64561, 64561-50, 64590 Outpatient - Trial unilateral / bilateral: $6,563 Outpatient - Permanent implant, system: $21,444 ASC - Trial unilateral CMS 64561: $5,218 ASC - Trial bilateral CMS 64561-50: $10,436 ASC - Permanent Implant CMS 64590: $19,672 |
|---|---|
| Surgery: | Requires ~3 to 5 cm (~1-2 inch) incision, then blunt dissection to form pocket for the stimulator intended to be implanted |
| Placement Location: | S2-S4, typically S3 |
| Trial: | Peripheral Nerve Evaluation (PNE) lead placed for up 7 to 14 days |
*The reimbursement information, including CPT®, HCPCS, and CMS codes, coverage levels, and related policies, is provided for general informational purposes only. While we have made efforts to compile accurate information from publicly available sources (including CMS, FDA, and medical device manufacturer websites), coding, coverage, and payment policies are subject to change without notice. This information does not constitute legal, financial, billing, or reimbursement advice. Users are responsible for verifying coding, coverage, and payment information with the appropriate payers and should consult with their own reimbursement, compliance, or legal advisors regarding any specific questions. We make no representation, warranty, or guarantee that use of the information provided will result in coverage or payment.
Axonics Sacral Neuromodulation System
Courtesy of the FDA:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180046
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190006
| Product Name: | Axonics Sacral Neuromodulation System |
|---|---|
| Generic Name: | Stimulator, tibial, electrical, implantable, for urinary incontinence |
| Applicant: | Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY MARLBOROUGH, MA 01752 |
| PMA Number: | P180046 // P190006 |
| Date Received: | 12/06/2018 // 03/04/2019 |
| Decision Date: | 11/13/2019 // 09/06/2019 |
| Product Code: | EZW // QON |
| Advisory Committee: | Gastroenterology/Urology |
| Clinical Trials: | NCT03327948 // NCT03327948 |
| Battery: | EZW: Yes, rechargeable. 15 year lifespan. |
Additional info:
| Reimbursement*: | CMS 64561, 64561-50, 64590 Outpatient - Trial unilateral / bilateral: $6,563 Outpatient - Permanent implant, system: $21,444 ASC - Trial unilateral CMS 64561: $5,218 ASC - Trial bilateral CMS 64561-50: $10,436 ASC - Permanent Implant CMS 64590: $19,672 |
|---|---|
| Surgery: | Requires ~3 to 5 cm (~1-2 inch) incision, then blunt dissection to form pocket for the stimulator intended to be implanted |
| Placement Location: | S2-S4, typically S3 |
| Trial: | Peripheral Nerve Evaluation (PNE) lead placed for up 7 to 14 days |
*The reimbursement information, including CPT®, HCPCS, and CMS codes, coverage levels, and related policies, is provided for general informational purposes only. While we have made efforts to compile accurate information from publicly available sources (including CMS, FDA, and medical device manufacturer websites), coding, coverage, and payment policies are subject to change without notice. This information does not constitute legal, financial, billing, or reimbursement advice. Users are responsible for verifying coding, coverage, and payment information with the appropriate payers and should consult with their own reimbursement, compliance, or legal advisors regarding any specific questions. We make no representation, warranty, or guarantee that use of the information provided will result in coverage or payment.
Treatment parameters:
| Amplitude Range | 0 - 12.5 mA |
|---|---|
| Frequency | 2.1-130 Hz |
| Pulse Width | 60-450 μs |
| Stimulation Output | Current Controlled |
| Stimulation Modes | Unipolar and bipolar |
| Cycling Mode | Yes |
| Ramp feature | Yes |
| Battery capacity | 50 mAh (3.6 V nominal voltage) |
| Device life | 15 Years (at moderate energy) |