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.
Boston Scientific Reports Q3 2019: CRM up 0.6%, Neuromodulation up 17.5%
Boston Scientific announced today its financial results for Q3 2019. According to the press release, Cardiac Rhythm Management went up from $475M in Q3 2018 to $478M in Q3 2019.
In its neuromodulation business, Q3 2019 brought $222M compared to $189M for the same period last year.
Among recent developments, Boston Scientific “Announced the U.S. Food and Drug Administration (FDA) approval of ImageReady™ MRI labeling for the Vercise Gevia™ Deep Brain Stimulation (DBS) System to be used in a full-body magnetic resonance imaging (MRI) environment .”
GTX and NeuroRecovery Technologies Merge
Image Credit: GTX Medical
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
Image Credit: Medtronic
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
Image Credit: Medtronic
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.
First Clinical Implant of Synchron’s Stentrode® Minimally-Invasive Neural Interface
Image Credit: Synchron
Synchron Inc. announced today the first successful clinical implantation of the Stentrode®, a minimally-invasive neural interface technology, a component of the Synchron Brain-Computer Interface. This is the first clinical feasibility trial evaluating this technology for its potential to restore communication in people with severe paralysis.
iota Biosciences’ “Neural Dust”
Image Credit: iota Biosciences
iota Biosciences was established in 2017, building up on the concept of “neural dust” technology invented at the University of California, Berkeley by iota co-founders and co-CEOs Jose Carmena, Ph.D. and Michel Maharbiz, Ph.D.
iota’s “neural dust” consists of a small implantable device (a few mm long) that is powered from an external ultrasound generator. According to iota, their devices can record electrical information, stimulate nerves and communicate with other machines through ultrasound. Iota claims that “neural dust” devices can modulate the information transmitted through nerves, enabling doctors to better treat conditions from arthritis to cardiovascular disease
In 2018 iota completed a $15 million series A funding round aimed at developing a sensing platform. In September 2019, iota entered into a joint R&D agreement with Japanese Astellas Pharma to “design detailed specifications of implantable medical devices and conduct preclinical studies for several diseases with high unmet medical needs.”
Eventually, iota hopes to shrink the device to the size of grain of sand that can simultaneously sense neural activity and stimulate nerves to enable highly-targeted closed-loop therapies.
iota Biosciences’ website is at: https://iota.bio/
Can the Government Really Read Your Mind using Brain Implants? (Spoiler Alert: NO, they Can’t!)
I’ve stopped watching CNN, because it has become as bad and radically polarized as FOX news is on the other side of the spectrum, so it was an external reference that sent me to the following CNN article by Dominic Rech:
“Brain implants could give governments and companies power to read your mind, scientists warn“
So… now CNN is not only the mouthpiece for the far left, but like FOX News (which I consider a parody channel) has also turned into a pusher of ridiculous conspiracies.
Sure, neural implants can read specific motor patterns that, with exhaustive training of the subject, can be used as a brain-machine interface. However, that is an extremely far cry from being able to surreptitiously read someone’s mind or implant thoughts into people (AKA “synthetic telepathy”).
CNN’s Rech quotes a report by Dr. Tim Constandinou and his colleagues at the Next Generation Neural Interfaces (NGNI) Lab at Imperial College London. However, the report doesn’t imply anything of the sort of the sensationalistic title chosen by CNN.
Bottom line: NO, the Government and Private Companies will not be able to either read or place thoughts into your mind any time soon through brain implants!
Now, my main issue isn’t that CNN is using a ridiculous headline as click bait, but rather it is the fact that such reporting is irresponsible and outright dangerous.
Despite a clear notice that I won’t address such queries, I still receive copious amounts of e-mail messages from people who believe that they have been surreptitiously implanted with electronic devices to harass and spy on them. Mr. Rech’s article recklessly provides fuel for such psychotic thoughts, and legitimizes a conspiracy that discourages these people from receiving the psychiatric care they so critically require.
Shame on you Dominic Rech and CNN!
Axonics Receives FDA Approval for its r-SNM Implantable Sacral Neurostimulator for 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. Axonics announced today that it had received FDA approval for the clinical indication of fecal incontinence. The 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. Axonics has an additional pre-market approval (“PMA”) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term.
BackBeat Medical Gains CE-Mark for Moderato Device for Treating Hypertension
BackBeat® Medical in New Hope, PA, a subsidiary of Orchestra BioMed, Inc. announced that it received the CE Mark for its Moderato® device. BackBeat’s Cardiac Neuromodulation Therapy (CNT) is a patented implantable cardiac stimulation-based treatment for hypertension that immediately and substantially lowers blood pressure. The stimulation algorithms in the Moderato® device are designed such that they simultaneously modulate autonomic nervous system responses that normally drive and maintain blood pressure higher. The Moderato® device also provides standard DDDR pacemaker functions.
The Cardiovascular Research Foundation (CRF) selected the MODERATO II clinical study for a late-breaking science presentation at TCT 2019 (September 28, 2019) by Karl-Heinz Kuck, MD., Ph.D., Director of Cardiology at the Lans Medicum, Hamburg, Germany and principal investigator for the MODERATO Studies.
The website for BackBeat is at: https://orchestrabiomed.com/technology/backbeat-cnt/
FDA Approves Boston Scientific’s ImageReady™ MRI For Vercise Gevia™ DBS
Image Credit: Boston Scientific
Boston Scientific announced the U.S. Food and Drug Administration (FDA) approval of its ImageReady™ MRI labeling for the Vercise Gevia™ Deep Brain Stimulation (DBS) System to be used in a full-body MRI (1.5 Tesla MRI conditional when all conditions of use are met). This system, with the Vercise Cartesia™ Directional Lead, is designed to treat the symptoms of Parkinson’s Disease (PD) by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects.
Medtronic Q1 FY2020: Cardiac Rhythm & Heart Failure Down 3.1%, Pain Therapies Down 7%
Medtronic announced today its financial results for its first quarter of fiscal year 2020. As a whole, the company reported first quarter worldwide revenue of $7.493 billion, an increase of 1.5 percent.
However, Cardiac Rhythm & Heart Failure decreased 3.1 percent as reported (1.2 percent on a constant currency basis). According to the press release”
“Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by mid-single digit growth in Pacemakers, including mid-twenties growth of the Micra® transcatheter pacing system, as well as mid-thirties growth of the TYRX® absorbable antibacterial envelope, high-single digit growth of the Reveal LINQTM insertable cardiac monitoring system, and high-single digit growth in AF Solutions, all on a constant currency basis. Arrhythmia Management growth was offset by low-double digit declines in Heart Failure, including high-forties declines in sales of left ventricular assist devices (LVADs), both on a constant currency basis.”
Pain Therapies, the other area of Medtronic’s business that depends heavily on active implantable medical devices also took a hit, with first quarter revenue of $292 million decreased 7.0 percent as reported or 6.1 percent on a constant currency basis. The announcement explains:
“Pain Stimulation declined in the low-double digits, reflecting channel destocking and the overall slowdown of the spinal cord stimulation market.”
CVRx Receives FDA Approval for its BAROSTIM NEO™ to Treat Heart Failure
Image Credit: CVRx
Minneapolis-based CVRx received FDA approval yesterday for its BAROSTIM NEO™ device to treat Heart Failure.
The BAROSTIM NEO™ implantable pulse generator is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck, targeting its baroreceptors. The proposed mechanism of action is that the activation of baroreceptors cause the brain to relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.
The no-panel approval was based on results from CVRx’s BeAT-HF phase III trial on 264 patients randomized to two arms: 130 subjects randomized to receive a BAROSTIM NEO™ were compared to 134 subjects randomized to stay on guideline-directed medical therapy. The implanted group showed the following improvement in symptomatic endpoints as compared to the control group:
- Improved their MLWHFQ score by 14 points,
- Improved their 6-minute hall walk by 60 meters, and
- Improved their NYHA status.
According to FDA’s press release, the BAROSTIM NEO™ System is indicated for the improvement of symptoms in patients with advanced heart failure (EF≤35%) who are not suited for treatment with other heart failure devices.
CVRx website: www.cvrx.com
Berlin Heals First-In-Man Pilot Trial of its C-MIC Device
Image Credit: Berlin Heals
Berlin Heals GmbH – a private Switzerland-based company with an R&D branch in Berlin, Germany – started a FIH-Pilot-Trial of its C-MIC device at AKH Vienna and at the Hospital Center Dedinje in Belgrade.
The C-MIC is an implantable electroceutical device intended to readjust the disturbed myocardial electrical gradient that, according to Berlin Heals, occurs in heart failure patients.
Dr. Peter Göttel from Berlin Heals told me that as of today, 4 patients have been implanted between the two sites.
Berlin Heals website: http://berlinheals.de/
Berlin Heals announcement: http://berlinheals.de/pilot-study-initiated/
C-MIC Device. Image Credit: Berlin Heals
Boston Scientific Reports Weak CRM and Neuromodulation Growth
Boston Scientific’s Q2 2019 results are out, and they show very weak growth for Cardiac Rhythm Management.
According to the announcement, Q2 2019 CRM sales were $498M, compared to $494M for the same period last year, which constitutes a 0.6% increase on reported basis.
Neuromodulation grew from $202M last year to $204M, or 1.0% on reported basis.