A blog about what is new (and old) in the world of active implantable medical devices

Monthly Archives: March 2019

Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV ICD)

Posted on by Posted in Cardiac Pacing, Cardioversion/Defibrillation, Medtronic, Tachycardia
Medtronic EV ICD

Image Credit: Medtronic

Things have gone well for Boston Scientific with its subcutaneous implantable cardioverter defibrillator (S-ICD). These devices have no transvenous leads, and as such provide a solution for patients at risk for SCD when implantation of a traditional ICD with transvenous leads is not possible or desired.

S-ICDs have their disadvantages though – current models are larger in size because of the high energy they must deliver to defibrillate from a subcutaneous lead (as a reference, Boston Scientific’s EMBLEM S-ICD delivers 80J shocks), and do not provide antitachycardia pacing (ATP) or bradycardia pacing support, except for limited post-shock pacing.

Medtronic is proposing a different approach to Boston Scientific’s. They call it the Extravascular Implantable Cardioverter Defibrillator (EV ICD), which uses a lead placed under the sternum, which gets the electrodes much closer to the heart than Boston Scientific’s subcutaneous lead.

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The Continuing CMS Coverage Saga of Cyberonics/LivaNova’s Vagus Nerve Stimulation for Treatment-Resistant Depression

Posted on by Posted in Cyberonics, Depression, LivaNova, Vagus Nerve Stimulation

LivaNova SenTiva VNS
Image Credit: LivaNova

Back in July, 2005, the FDA approved Cyberonics (now LivaNova) VNS implant for patients with chronic or recurrent depression, either unipolar or bipolar, with a history of failure of the depression to respond to at least four antidepressant interventions.

However, the U.S. Centers for Medicare & Medicaid Services (CMS) declined covering VNS for serious depression. CMS concluded back in 2007 that VNS’ effectiveness was not compelling enough to expand coverage, leaving drug-resistant epilepsy as its only covered indication.

Ten years later LivaNova presented data from a five-year study of VNS for treating TRD which showed that patients with chronic moderate to severe TRD experienced anti-depressant effects at a significant rate when treated with the therapy.

In response, last month (February 2019) CMS said:

“Based on the evidence, we believe that VNS for TRD seems promising but not convincing.” “To ensure benefits to Medicare beneficiaries we are proposing to cover VNS for the treatment of TRD when offered in double-blind, randomized, placebo-controlled studies.”

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Bioness’ StimRouter Implantable Neurostimulator Reroutes TENS Pulses

Posted on by Posted in Bioness, Pain, PNS, Sacral Root Stimulation, Spinal Cord Stimulation, Wireless Power Transmission

Bioness' StimRouter implantable neurostimulator. www.implantable-device.com David Prutchi PhD

Bioness is a Valencia, California medical device/rehabilitation company founded by the late Alfred Mann some 15 years ago. He had previously acquired a miniature stimulator called the BION, and a company called NESS who had a footdrop stimulator. The combination of the two is where the name Bioness came from.

One of its products is the “StimRouter”, which is an externally-powered implantable peripheral nerve stimulator designed to reduce chronic pain. It gained FDA approval in 2015 and was launched in mid-2016.

Unlike most externally-powered neurostimulators however, the StimRouter is not powered by RF received from the external transmitter. Instead, the external pulse transmitter is more like a TENS unit with gelled electrodes applied to the skin. The implant has no electronic components. It is just a lead that has a coil electrode that intercepts part of the current between the TENS electrodes, and routes the captured current to small electrodes in contact with the target nerve at the distal end of the lead.

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DHS Warns of Cybersecurity Exploits Against Some Medtronic Devices

Posted on by Posted in Cardiac Pacing, Cardioversion/Defibrillation, Cybersecurity, Medtronic

Pacemaker cybersecurity

The U.S. Dept. of Homeland Security has issued a medical advisory warning of vulnerabilities and exploits against Medtronic’s implantable CRM devices and ancillaries.  These exploits could allow an attacker to affect the functionality of the devices or intercept sensitive data.

The exploit affects Medtronic devices that use its Conexus telemetry protocol. Affected devices include all models of the Amplia CRT-D, Claria CRT-D, Compia CRT-D, Concerto CRT-D, Concerto II CRT-D, Consulta CRT-D, Evera ICD, Maximo II CRT-D and ICD, Mirro ICD, Nayamed ND ICD, Primo ICD, Protecta ICD and CRT-D, Secura ICD, Virtuoso ICD, Virtuoso II ICD, Visia AF ICD, Viva CRT-D, the CareLink 2090 Programmer, the 2490C version of its CareLink Monitor and versions 24950 and 24952 of its MyCareLink Monitor.

Medical Advisory (ICSMA-19-080-01) can be read at: https://ics-cert.us-cert.gov/advisories/ICSMA-19-080-01

 

FDA Approves breakthrough Optimizer® Smart System Delivering CCM™ Therapy for Treatment of Heart Failure

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Stimulation (other), David Prutchi's Portfolio, Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics

I have led the development of devices to deliver CCM™ therapy from the very beginning, so it is with great pleasure and pride that I share with you the exciting news that Impulse Dynamics just received approval from the United States Food and Drug Administration (FDA) for our Optimizer® Smart System for heart failure patients!  An official FDA announcement was made through the publication of a press release that you can find here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm.

Impulse Dynamics’ press release is as follows:

Impulse Dynamics receives FDA approval for breakthrough Optimizer® Smart System delivering CCM™ therapy for treatment of heart failure

Orangeburg, New York, March 21, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System.

Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device designation from the FDA in 2015. It was the first breakthrough device to go before the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee, on Dec. 4, 2018, receiving a 12-0 vote on the benefit-to-risk ratio of the device.

“With the FDA’s approval of the Optimizer System for the delivery of CCM, we finally have available in the US an effective device-based therapy for advanced heart failure patients with mildly to moderately reduced left ventricular ejection fractions who are not eligible for CRT,” said Professor William T. Abraham, MD, Professor of Medicine, Physiology, and Cell Biology, and College of Medicine Distinguished Professor at the Ohio State University Wexner Medical Center. “The Optimizer System, along with guideline-directed medical therapies, can improve the lives of many heart failure patients in the US who previously did not have access to this therapy. As such, it represents a real game-changer for these patients.”

The Optimizer Smart System is the first and only CCM device approved by the FDA to improve 6-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT, and have an LVEF ranging from 25% to 45%. Only 30 percent of moderate to severe chronic heart failure patients are candidates for CRT, which historically has left 70 percent of patients with few options to help them manage their disease.

“FDA approval is the culmination of many years of clinical development for this disruptive technology, addressing a significant unmet need in today’s heart failure treatment paradigm,” commented Dr. Daniel Burkhoff, Impulse Dynamics’ Medical Advisor. “We continue to develop the technology with ongoing clinical trials designed to evaluate CCM therapy in additional heart failure populations.”

CCM is a unique electrical pulse delivered during the absolute refractory period, which is just after the heart contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm.

Dr. Simos Kedikoglou, Impulse Dynamics’ CEO, announced that the Company will launch the device in the US later this year.  “We are extremely excited that the Optimizer Smart System with CCM therapy is now available in the United States,” he said. “We look forward to growing our commercial presence in the US and globally.”

About the Optimizer and CCM Therapy
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 80 papers in leading medical journals.

About Impulse Dynamics
Impulse Dynamics is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, and Asia. For more information please visit www.impulse-dynamics.com.

Impulse Dynamics (USA), Inc.
30 Ramland Road South, Suite 204
Orangeburg, NY 10962

Nyxoah Receives CE Mark for Genio® System for Treating Obstructive Sleep Apnea

Posted on by Posted in Nyxoah, Obstructive Sleep Apnea
Nyxoah's miniature implant Genio implantable bilateral hypoglossal nerve stimulation for treatment of Obstructive Sleep Apnea

Nyxoah’s Genio implantable bilateral hypoglossal nerve stimulation for treatment of Obstructive Sleep Apnea
Image Credit: Nyxoah

I previously described efforts by Nyxoah, which was founded in 2009 by Robert Taub and Dr. Adi Mashiach in Mont-Saint-Guibert, Belgium, to develop neurostimulation treatments focused for Obstructive Sleep Apnea.

Nyxoah developed a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage during sleep. The implant is powered and controlled by a disposable external adhesive patch. Every evening the OSA sufferer uses a new disposable patch that carries an “Activation Chip” that is positioned every night by the patient under the chin. The Activation Chip has its own battery and has enough energy to wirelessly activate the implanted neurostimulator for a full night sleep session.

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WEL Neuci-3M – An Ukrainian Neurostimulator for Nerve Regrowth

Posted on by Posted in Pain, Paralysis, Spinal Cord Stimulation, WEL (Kiev)

Neuci-3M by WEL

I was recently invited to visit a company in Kiev, Ukraine which manufactures implantable neurostimulators intended to cause nerve regrowth after spinal-cord or peripheral-nerve injury.

WEL was founded in 1993 for the development and production of electronics and microelectronics products. Its design and manufacturing facilities are located within a Soviet-era microelectronics manufacturing complex that is now largely abandoned.

WEL’s bread-and-butter is the production of industrial power control systems, but got into the medical implantables business after a request from a local hospital treating spinal-cord injury war casualties.

WEL’s main neurostimulator system is the “Neuci-3M” two-channel, externally RF-powered system. The implant is a simple two-frequency passive receiver potted in epoxy and overmolded with silicone rubber. The external transmitter is responsible for controlling all stimulation parameters. WEL also produces their own leads, including one with “petal” electrodes specifically for the stimulation of nerve regrowth.

WEL’s homepage is at: http://www.wel.net.ua/  They don’t have an English webpage, but Google translate does pretty well when viewing the page through Chrome.

Clinical work with this neurostimulator is conducted mainly by the Academician A. P. Romodanov Institute of Neurosurgery of the Academy of Medical Sciences of Ukraine.

FDA Approves Biotronik’s Acticor and Rivacor CRM Device Families. Biotronik Changes IPG Shape?

Posted on by Posted in Biotronik, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia

Image Credit: Biotronik

FDA has approved Biotronik’s Acticor and Rivacor high-voltage CRM Device Families. According to the press release the six new tachycardia solutions include Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX.

The Acticor and Rivacor IPGs have a smooth, elliptical “BIOshape” and are the smallest and slimmest 3 Tesla (3T) MR-conditional CRM devices currently on the market. The devices also feature extended longevity—nearly 15 years for VR-T, 13.5 years for DR-T, 14 years for DX and nine years for CRT.

The Acticor family offers Biotronik’s “DX technology”, which provides atrial diagnostics without an atrial lead. DX systems can detect silent atrial fibrillation for stroke prevention, enhance diagnostic accuracy for better clinical decision-making and allow for dual-chamber supraventricular tachycardia (SVT) discrimination to prevent unnecessary shocks.

The Rivacor HF-T QP offer 20 LV pacing vectors and cardiac resynchronization therapy (CRT) optimization with intelligent CRT AutoAdapt programming to automatically adjust to changes in patient conditions.

Acticor and Rivacor also feature MRI AutoDetect technology, which automatically recognizes when a patient enters an MRI environment and adjusts therapy for the duration of the scan.

Biotronik’s website: https://www.biotronik.com

NewPace Medical Developing the “Implantable Subcutaneous String Defibrillator” (ISSD™)

Posted on by Posted in Cardioversion/Defibrillation, Tachycardia

From: P Neuzil, “First-In-Man Feasibility Study of Subcutaneous Defibrillation Utilizing and Integrated Flexible String Defibrillator”, Heart Rhythm, 2017, 1948, C-LBCT03-01

A few years ago (2016, I think), a mockup of a curious device reminiscent of the InnerPulse PICD was displayed at HRS by NewPace, a company based in Caesarea, Israel. Their Implantable Subcutaneous String Defibrillator (ISSD™) device is meant to be implanted subcutaneously with no leads connected directly to the heart. It is described by NewPace as “unitary and flexible: totally integrated (no can, nor leads) and flexible string shape device”. According to NewPace, the device will be rechargeable, requiring a one hour session once yearly, and will have a longevity of 10 years before needing replacement.

In contrast to standard S-ICDs, the device could be easily implanted with only 3 small incisions and no need to create a pulse generator pocket. This implant is expected by NewPace to have minimal anatomical protrusion, resulting in better patient comfort and aesthetic appearance compared to a standard S-ICD.

At HRS 2017, NewPace presented a human study whereby the electrode configuration envisioned for the ISSD was used to defibrillate patients using an external defibrillator prior to the implantation of a standard ICD. In this acute study, the electrode configuration proposed for the ISSD resulted in an average DFT of 26J (n=22, SD=11J). The abstract described a protocol with 70J as the maximum energy to be used for DFT, and the presenter discussed the probability of defibrillation success at 60J making me believe that the ISSD will have its maximum energy at 60J (as a reference, Boston Scientific’s EMBLEM S-ICD delivers 80J shocks)

Dr. Neuzil from the Czech Republic, who conducted the acute study on the electrode configuration, gave some additional details on the proposed device:

“The configuration consists of an integrated and flexible structure with a string which is 45fr, including the active segment, and two shocking coils of 10cm each at 15fr and 9fr. The two coils are to the mid sternum and lateral axillary line. These are connected to the cable string, which contains all the batteries, capacitors, and communication system. So it is one body. This is implanted subcutaneously.”

NewPace’s website: https://www.newpacemedical.com

Historical Piece: InnerPulse’s Percutaneous Intravascular Cardioverter-Defibrillator (PICD)

Posted on by Posted in Cardioversion/Defibrillation, InnerPulse, Museum, Tachycardia

InnerPulse Percutaneous Implantable Crdioverter Defibrillator PICD (c) David Prutchi, Ph.D. www.implantable-device.com

 

InnerPulse was founded in Raleigh, North Carolina, in 2003 to develop an intravascular defibrillator placed completely within the vasculature.

The idea was that unlike typical CRM devices, the InnerPulse fully intravascular defibrillator (PICD™) technology would be implanted percutaneously utilizing a catheter-based procedure. Additionally, the implant procedure would be familiar to both electrophysiologists (who currently implant the majority of CRM devices) and other implanting cardiologists, and was thought to have significantly lower infection rates than surgical procedures. The intravascular device was also touted by InnerPulse as having potential reliability advantages, including the virtual elimination of performance issues associated with cardiac leads and device headers. In addition, because the IID does not require a surgical pocket, patients would benefit through lower post-procedure discomfort and improved cosmesis. In the end, the device would be imperceptible to the patient and will address known barriers to patient acceptance of an implanted device.

By 2008, backed with $85M by Industry giants such as Johnson & Johnson Development Corporation, Medtronic, Inc., Synergy Life Science Partners, Ascent Biomedical Ventures, Delphi Ventures, Frazier Heathcare Ventures, Boston Scientific, and Greatbatch, Inc. InnerPulse had developed an intravascular, percutaneously placed implantable defibrillator (InnerPulse percutaneous intravascular cardioverter-defibrillator [PICD]) with a right ventricular (RV) single-coil lead and titanium electrodes in the superior vena cava (SVC) and the inferior vena cava (IVC).

InnerPulse Percutaneous Implantable Crdioverter Defibrillator PICD (c) David Prutchi, Ph.D. www.implantable-device.com

The device itself was a masterpiece of engineering, featuring a completely hermetical but flexible enclosure. The flexible interfaces between the cylindrical segments was provided by titanium bellows with internal flexible wiring. The batteries and defibrillation capacitors were custom-made for this device. Circuitry was all laid-out in flexible boards that would be folded to accommodate the cylindrical geometry.

InnerPulse Percutaneous Implantable Crdioverter Defibrillator PICD (c) David Prutchi, Ph.D. www.implantable-device.com

Control Module for the InnerPulse PicD

The PICD’s control circuit was powered by a CFx battery, while energy for defibrillation was produced by a stack of two SVO cells.

InnerPulse Percutaneous Implantable Crdioverter Defibrillator PICD (c) David Prutchi, Ph.D. www.implantable-device.com

SVO Cell Stack for the InnerPulse PICD

 

InnerPulse Percutaneous Implantable Crdioverter Defibrillator PICD (c) David Prutchi, Ph.D. www.implantable-device.com

CFx battery used to power the PICD’s Control Circuitry

 

InnerPulse Percutaneous Implantable Crdioverter Defibrillator PICD (c) David Prutchi, Ph.D. www.implantable-device.com

HV Capacitor for the InnerPulse PICD

Tests in human subjects showed similar defibrillation thresholds compared to a standard ICD. In a 10-subject study, PICD DFT was 7.6 ± 3.3 J, and the conventional ICD system demonstrated a mean DFT of 9.5 ± 4.7 J (N = 10; paired t test, P = .28). Unfortunately however, a chronic animal study revealed problems of lead dislodgement, loss of capture, and perforation.

Ultimately, Boston Scientific decided to acquire Cameron’s Subcutaneous ICD (S-ICD) and stopped backing InnerPulse. InnerPulse was dissolved after it had no money left for resolving the technical issues and conducting chronic human clinical trials.

Saluda Medical’s Closed-Loop Evoke SCS Device for Pain

Posted on by Posted in Pain, Saluda Medical, Spinal Cord Stimulation

Image credit: Saluda Medical

Back in 2013 I reported that Sydney, Australia-based Saluda Medical had started the development of a closed-loop SCS system for pain.

Since then, Saluda has gone through a number of financing rounds, the latest being all-equity $40M from Action Potential Venture Capital (APVC, a GSK fund that invests in companies developing bioelectronic medicines) and Medtronic.

Saluda’s rechargeable Evoke Spinal Cord Stimulator is meant to detect the neural signals evoked by the stimulation system to maintain effective stimulation levels. The idea is that based on the evoked-potential feedback, as well as its knowledge of the user’s preferences, will allow the system to personalize therapy for optimal response against pain.

Saluda has presented long-term clinical data from its first chronic implant study, which was conducted in Australia. According to the presented results, at 6 months, subjects with axial back pain experienced an average sustained improvement of 80% relief. In addition, the 32-patient cohort showed clinically meaningful improvements in function, disability, and sleep.

Saluda Medical’s website: https://www.saludamedical.com

BackBeat® Medical’s Cardiac Neuromodulation Therapy (CNT) for Hypertension

Posted on by Posted in BackBeat Medical, Cardiac Neuromodulation, Hypertension

Image Credit: BackBeat Medical

BackBeat® Medical in New Hope, PA is a subsidiary of Orchestra BioMed, Inc.   BackBeat’s Cardiac Neuromodulation Therapy (CNT) is a patented implantable cardiac stimulation-based treatment for hypertension that the company claims immediately and substantially lowers blood pressure. The stimulation algorithms are designed such that they simultaneously modulate autonomic nervous system responses that normally drive and maintain blood pressure higher.  This is explained in the following video:

According to a paper presented at AHA in 2017:

“The Moderato System (BackBeat Medical, New Hope, PA), is a dual-chamber, rate-responsive pacemaker implantable pulse generator (IPG), which incorporates PHC algorithms that pace the heart with a series of variably timed, alternating shorter (eg, 20–80 ms) and longer (eg, 100–180 ms) atrioventricular intervals. Details of PHC therapy optimization are discussed below; in general, the pacing sequence consists of 8 to 13 beats with the shorter atrioventricular delay followed by 1 to 3 beats with the longer atrioventricular delay. The device is active 24 h/d and paces the right ventricle on nearly every beat.”

BackBeat presented results from its Moderato trial at TCT 2018. Clinical results with 2-year follow-up from the European MODERATO I clinical trial showed that BackBeat® CNT can reduce systolic blood pressure measured in office by an average of 23.4 mmHg, an amount that has the potential to reduce risk of heart attack and stroke by at least 50%.

According to BackBeat, the technology can be readily incorporated into existing cardiac rhythm management devices such as pacemakers using standard implant and lead placement techniques. BackBeat has indicated that it is pursuing the CE Mark for its Moderato IPG.

The website for BackBeat is at: https://orchestrabiomed.com/technology/backbeat-cnt/

Mainstay’s Medical ReActiv8® for Lumbar Spine Muscle Stimulator for Chronic Low Back Pain

Posted on by Posted in Muscular Stimulation, Pain

Image Credit: Mainstay Medical

Mainstay is a European medical device company headquartered in Dublin, Ireland. Mainstay has developed the ReActiv8® implantable neurostimulator intended for helping people with disabling Chronic Low Back Pain.

The ReActiv8® implantable neurostimulator is designed to electrically stimulate nerves to key stabilizing muscles of the lumbar spine thereby activating these muscles. The concept is that restoration of muscle activation is an important step in the treatment of chronic low back pain.

The ReActiv8® includes two leads which are placed bilaterally near the medial branch of the dorsal ramus nerve at the L3 vertebra, and are connected to the IPG. CE approval for the device was granted in May of 2016.

According to Mainstay, the therapy is similar to exercise programs used to restore muscle control in that ReActiv8 sessions are delivered twice a day for about 30 minutes under the patient’s via a handheld wireless remote control.

Mainstay expects that over time, the stimulated activation will help the patient’s brain and body learn how to better control the muscles in between sessions, and thus recover from chronic low back pain.

Mainstay’s Medical website: http://www.mainstay-medical.com

MicroTransponder’s VNS Vivistim™ System Intended for the Treatment of Stroke

Posted on by Posted in Micro Transponder, Stroke, Tinnitus, Vagus Nerve Stimulation

Image credit: MicroTransponder

Back in 2013 I reported about MicroTransponder’s Serenity System™, which pairs Vagus Nerve Stimulation (VNS) with listening to tones. During the therapy, an individual sits in a comfortable chair and wear headphones. They listen to tones while receiving small bursts of neurostimulation from the implantable vagus-nerve stimulator. UT Dallas says that “preclinical tests demonstrated that this approach “rewires” damaged brain circuitry associated with tinnitus, potentially yielding long-term reversal of symptoms. The initial human trial in Belgium provided encouraging results.”

More recently, MicroTransponder developed the Vivistim™ system intended for the treatment of stroke.   The implant is based on the idea that synchronizing vagus nerve stimulation with movement increases neural plasticity in the brain, resulting in enhanced recovery.

In May 2017 MicroTransponder presented results from its Vivistim™ Stroke Rehabilitation trial. The objective of this multicenter, double-blind, randomized, active-controlled trial was to improve upper limb mobility in stroke survivors suffering chronic disability. The data showed 75% of patients had a clinically meaningful response on the Fugl-Meyer Upper Extremity Scale (FMUE) at the end of a six weeks of physical therapy compared to 33% for the control group. 90 days after the six weeks of physical therapy ended 88% of VNS patients had responded compared to 33% in the control arm. And during the long-term portion of the study average FMUE scores continued to increase, with the 6 month and 9 month data showing further gains. All responders indicated they believed their overall health had improved and were satisfied with the therapy.

At the same time, MicroTransponder announced that it had received IDE approval from the FDA to run a 120-patient pivotal trial on the Vivistim™ system.

MicroTransponders website: http://www.microtransponder.com

Operation of Vivistim System
Image credit: MicroTransponder

Axonics’ r-SNM Implantable Sacral Neurostimulator for Urinary and Bowel Dysfunction

Posted on by Posted in Axonics, Bowel Discfunction, Incontinence, Sacral Root Stimulation
Axonics' r-SNM Implantable Neurostimulator for Urinary and Bowel Dysfunction

Image Credit: Axonics

Axonics Modulation Technologies is an Irvine, CA company founded in 2013 that developed a novel implantable sacral nerve stimulator to treat patients with urinary and bowel dysfunction disorders.

The Axonics r-SNM system is a miniaturized rechargeable implantable stimulator with a longevity of at least 15 years. The system also features a charging system designed for quick charge times and a user-friendly remote control and programming interface.

The r-SNM device won CE Mark approval in June 2016, and is currently pursuing FDA approval using its “literature-based PMA submission”.  This type of submission relies on supporting literature that is “sufficient, detailed, objective, and directly applicable to the subject device.”  Axonics is quoting the Medtronic InterStim II device, which is the only U.S.-approved sacral neurostimulator. Axonics also provided to FDA one-year post-market data from its 51-patient European Relax-OAB study.

In February 2019 Axonics announced that its IDE pivotal clinical study demonstrated that patients implanted with the r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of life, met all secondary endpoints, and no serious device-related adverse events were reported.

Axonics had an Initial Public Offering in November 2018 which yielded $138M.

Axonics website:  http://www.axonicsmodulation.com/

Image Credit: Axonics