Dr. Ishu Rao is the Medical Director for Impulse Dynamics – the company where I am Executive VP of Product Development. Medgadget featured a very interesting interview with Dr. Rao where he described the use of CCM™ therapy for the treatment of Heart Failure.
Category Archives: Treated Conditions
Implantable Devices to treat specific conditions
SCS Companies Developing “Low Dose” Recharge-Free Spinal Cord Stimulation Devices
Spinal Cord Stimulation uses quite a bit of power, which is why SCS IPGs have either been rechargeable, or operated from a primary cell, but compromised on longevity.
Because recharging is sometimes perceived by patients as a hassle, SCS companies have been developing and testing “low-dose” stimulation regimens with the intention of yielding high-longevity SCS IPGs that don’t require recharging.
In September 2019 FDA approved Abbott’s Proclaim™ XR neurostimulation system which uses Abbott’s proprietary, low energy BurstDR™ therapy coupled with the BoldXR™ low dosing protocol for safe, effective pain relief and a battery that lasts up to 10 Years (at low-dose settings).
Approval was based on the results of the “BurstDR micrOdosing stimuLation in De-novo” patients (BOLD) study, which showed 100% of 24 enrolled patients on a low-energy BurstDR dosing program experienced pain relief with less than six hours of battery use per day, while approximately 50% of those patients achieved pain relief with the lowest effective dose (less than two hours of battery use per day). Even at the highest settings, the systems were still in use only 25% of the time.
SCS Company Nuvectra Filed for Bankruptcy
Back in 2013, implantable-grade component manufacturer Greatbatch Medical (now Integer Holdings) briefly entered the finished devices market with its own Algostim Spinal Cord Stimulator.
However, when Greatbatch acquired CCC Medical in 2014, having the Algostim SCS was seen as a conflict of interest by some of CCC’s SCS customers (e.g. Nevro), so in 2015/2016 Greatbatch divested its SCS business into a new company called Nuvectra.
Nuvectra never caused much of an impact in the SCS market, and trailed well behind Abbott, Boston Scientific, Medtronic, and Nevro. After limping along for a number of years, on November 12, 2019, Nuvectra filed for Chapter 11 bankruptcy.
James Cavuoto, Editor and Publisher of Neurotech Reports, wrote about possible reasons for Nuvectra’s failure:
“… Some critics of Nuvectra have cited management problems and quality control issues with its Algovita device as factors leading to the filing. Fred Parks, a medical device industry veteran with little experience in the SCS market, took over for founding CEO Scott Drees in January. Others have pointed to problems managing the company’s suppliers and an overly burdensome agreement Greatbatch required as part of the spinoff. …” [2019]
Bioness StimRouter CE-Marked to Treat Fecal Incontinence
Bioness announced that its StimRouter received the CE-Mark to Treat Fecal Incontinence.
Unlike most externally-powered neurostimulators, 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. Continue reading
Medtronic’s Percept™ PC Neurostimulator DBS System with BrainSense™ Receives CE-Mark
Medtronic announced that it received the CE Mark for Percept™ PC neurostimulator. The Percept™ PC neurostimulator; is the only Deep Brain Stimulation (DBS) system to be launched in the European Union (EU) with BrainSense™ technology that can sense and record brain signals while delivering therapy to patients with neurologic disorders, such as Parkinson’s disease.
According to the press-release:
“BrainSense technology enables physicians to track patient-specific brain signals and correlate these with patient-recorded events, such as symptoms or side-effects associated with their disease or the medications to treat it. This enables more personalized, data-driven neurostimulation treatment. The Percept PC neurostimulator is approved in the EU for the treatment of symptoms associated with Parkinson’s disease (PD), essential tremor, primary dystonia as well as epilepsy and obsessive-compulsive disorder (OCD). It is currently under review by the U.S. Food and Drug Administration.
“DBS is proven to significantly improve motor function in people with Parkinson’s disease compared to standard medication alone – but with currently-available systems, physicians need to make therapeutic decisions mostly based on clinical assessments and patient-reported information,” said Professor Andrea Kühn, head of Movement Disorders and Neuromodulation, Charité University Hospital, Berlin. “Percept PC with BrainSense technology is a game changer. Patients and their care teams will have objective patient-specific brain signal data – including data recorded outside the clinic in patients’ everyday lives. With this technology, doctors could tailor therapy more precisely to the individual needs of each patient based on data from neuronal activity.” “
GERD-Treatment EndoStim is Liquidated
EndoStim was a medical device company based in Dallas, Texas, and Nijmegen, The Netherlands, developing and commercializing a treatment for gastroesophageal reflux disease (GERD).
On October 15, 2019 EndoStim terminated its Clinical Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System due to lack of funding. According to a letter sent by EndoStim to its investigators, clinical and technical support will no longer be available for the devices after January 14, 2020
EndoStim terminated operations and entered into an Assignment for Benefit of Creditors under Delaware law, which is a state law liquidation procedure similar to a Chapter 7 bankruptcy.
Impulse Dynamics Secures $80.25M Funding from Major Investors Including Amzac, Wellington, and Zoll
Impulse Dynamics (where I’m Executive VP of Product Development) announced today the completion of an $80.25 Million Series D financing round with major new investors, including strategics. According to the press release:
“Impulse Dynamics, developer of Optimizer® Smart System for delivering CCM™ therapy, announced the completion of an $80.25 million Series D financing with new investors. The proceeds will be used primarily to facilitate U.S. commercialization of the Optimizer Smart, an FDA-approved implantable device for treating chronic heart failure that has been proven to strengthen the heart and help it beat more forcibly. Led by well-respected medical technology investor Amzak Health Investors, the round also included Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences and Minth Holdings Limited; strategic investors Zoll Medical Corporation, Abiomed and one additional corporate investor; and the company’s chief executive and chief financial officers.”
Daré Bioscience acquires Microchips Biotech Programmable Contraceptive Device
Daré Bioscience, a clinical-stage biopharmaceutical company developing innovative products for women’s health, announced it entered into an agreement to acquire privately-held Microchips Biotech, Inc. Daré entered into the agreement to secure Microchips’ innovative, drug delivery technology, which it intends to evaluate as a programmable contraceptive.
Medtronic’s Micra AV Uses Accelerometer to Maintain AV-Synchrony
Medtronic announced results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study showing that an investigational set of algorithms in the Micra™ leadless pacemaker improves synchrony and cardiac function in patients with atrioventricular (AV) block. Continue reading
What Happens When Fido Needs a Pacemaker?
Pets are prone to the same type of electrophysiological anomalies as humans, and pacemakers are often implanted to resolve bradycardia. Implants happen most commonly in dogs, but have also been used to treat cats and ferrets.
The dog breeds that most often have electrophysiological issues that can be treated with pacemakers are Miniature Schnauzers and West Highland White Terriers (typically for sick sinus syndrome), German Shepherds and Labrador Retrievers (typically for third degree AV block).
Human-use pacemakers (including resterilized devices explanted from patients who have passed away) are often used, but there are at least two brands of devices made specifically for veterinary use:
Impulse Dynamics Secures Transitional Pass-Through for OPTIMIZER Smart
Impulse Dynamics – the company for which I’m Executive VP of Product Development – announced that it has secured transitional pass-through (TPT) payment for the OPTIMIZER Smart System for the treatment of heart failure.
CMS has affirmed the substantial clinical improvement that Cardiac Contractility Modulation (CCM™ therapy) offers to patients with heart failure and adjusted the payment offered for the technology accordingly to facilitate access. The new payment, issued on Friday, Nov. 1, 2019 in CMS’s calendar year 2020 Outpatient Prospective Payment System (OPPS) final rule, eases access to CCM therapy in the hospital outpatient setting, with improved reimbursement taking effect on Jan. 1, 2020.
FDA Approves Impulse Dynamics’ Next-Generation 2-Lead OPTIMIZER Smart
Impulse Dynamics – the company where I am Executive VP of Product Development – announced the FDA approval of a PMA supplement for the next-generation, two-lead Optimizer Smart System for treating heart failure.
GTX and NeuroRecovery Technologies Merge
GTX Medical of The Netherlands and Switzerland, and NeuroRecovery Technologies, of San Juan Capistrano, California announced they intend to merge as GTX Medical with the goal of developing devices for restoring movement and the ability to walk in patients with paralysis and spinal cord injuries.
Shareholders and investors include the Christopher and Dana Reeve Foundation, LSP, Inkef, Wellington Partners, and GIMV.
The joint company will focus on developing two technologies to improve the functional recovery of people with spinal cord injuries:
- Targeted Epidural Spine Stimulation (TESS) – an implantable spinal cord stimulation system with real-time motion feedback
- Transcutaneous Spinal Cord Stimulation (tSCS) – a noninvasive device aimed at restoring upper limb movement and hand function
Medtronic Initiates Worldwide Pivotal Study for its Extravascular ICD
Medtronic announced today that it started a worldwide pivotal study evaluating its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system. The EV ICD system is designed to deliver lifesaving defibrillation and pacing therapy via a device the same size as traditional, transvenous ICDs, but with an extravascular lead placed outside the heart and veins.
According to the press release:
“The EV ICD pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that will assess the Medtronic EV ICD system in up to 400 patients at up to 60 sites in North America, Europe, the Middle East, Asia, Australia and New Zealand.
The study’s primary effectiveness endpoint is defibrillation testing success rate at implant. The primary safety objective is freedom from major system and/or procedural complications at six months after implant. Patients will be assessed at two weeks, three months, six months, and every six months thereafter.”
Medtronic Submits InterStim™ Micro Neurostimulator to FDA
Medtronic announced today that it had submitted its new InterStim™ Micro neurostimulator and matching InterStim™ SureScan™ MRI leads for PMA approval by FDA.
According to the press release:
“InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The SureScan™ leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval.”
It’s not common for companies to announce their submissions – usually one waits for approval – but this may be Medtronic’s way of signaling the market that it’s not far behind Axonics, which received FDA approval for a similar device last month.