Medtronic announced today that it has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left heart lead, and is designed for precise lead placement and stability. Medtronic said that the lead will be commercially available in the U.S. in summer 2019.
Category Archives: AIMD Companies
Biotronik Launches Single-Pass Dual-Chamber Defibrillation System
Biotronik announced yesterday the full commercial launch of the Acticor device family, including Acticor DX and CRT-DX devices. The unique feature of the system is the single-pass lead with its floating atrial sensing rings. According to the press release:
“When implanted with Biotronik’s Plexa ProMRI S DX lead, the hybrid ICD Acticor systems offer dual-chamber diagnostics without the need for an atrial lead. Importantly, all three Acticor DX devices feature a new DF4 header configuration with a penta-polar electrode lead cable design that simplifies the implant procedure for physicians.”
Synchron’s Stentrode™ Endovascular Neural Interface for BCI
Synchron is a Silicon Valley company that spun out of the University of Melbourne, Australia in 2012. It was started by Thomas Oxley, MD, PhD to develop a new concept for a Brain-Computer Interface
Synchron’s Stentrode™ is an endovascular neural interface. It is essentially an electrode array shaped as an endovascular stent that can be implanted via the jugular vein and advanced into the brain to the motor cortex. Neural signals are detected by the electrodes on the Stentrode™ and sent to a processing and communications unit implanted subcutaneously in the chest, and then wirelessly to an external receiver. The idea is that the device can interpret signals from the brain for patients with paralysis to control a computer operating system and set of applications that interact with assistive technologies.
Synchron is currently preparing for pilot clinical trials of the Stentrode™ to evaluate the safety and efficacy of this breakthrough technology.
Synchron’s website is at: https://www.synchronmed.com
Leviticus Cardio’s Coplanar Energy Transfer for Powering Ventricular Assist Devices
Leviticus Cardio, a company based in Petach Tikva, Israel, has been developing a wireless power transfer technology that they call “Coplanar Energy Transfer” (CET). The system supports high-efficiency (up to 75%) power transfer levels of up to 30 Watts, making it suitable for powering ventricular-assist devices.
Like other transcutaneous energy transfer systems, Leviticus is used on inductive power transfer between an external primary coil and an implanted secondary coil. However, instead of the traditional pancake coil subcutaneous implant, the CET coil is placed around the lung. The unique engineering of the coplanar energy transfer system is characterized by two large rings utilizing a coil-within-the-coil topology, ensuring robust resonance energy transfer Continue reading
Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV ICD)
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.
The Continuing CMS Coverage Saga of Cyberonics/LivaNova’s Vagus Nerve Stimulation for Treatment-Resistant Depression
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.”
Bioness’ StimRouter Implantable Neurostimulator Reroutes TENS Pulses
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.
DHS Warns of Cybersecurity Exploits Against Some Medtronic Devices
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
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
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.
WEL Neuci-3M – An Ukrainian Neurostimulator for Nerve Regrowth
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?
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
Historical Piece: InnerPulse’s Percutaneous Intravascular Cardioverter-Defibrillator (PICD)
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).
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.
The PICD’s control circuit was powered by a CFx battery, while energy for defibrillation was produced by a stack of two SVO cells.
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
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
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/