In December of 1995 FDA approved the Res-Q ACD. This was Intermedics’ first implantable defibrillator. The abdominal-implant device was a relatively late-comer, and large for the time (230 g), but it did offer the highest energy output (40 Joules). Another unique feature of the ResQ device was that it provided a connectorized sterile package which allowed complete pre-implant testing, thereby reducing the need for additional equipment.
Conceived by physicians Michel Mirowski and Morton Mower, and supported by Dr. Stephen Heilman, the first automatic implantable defibrillator was developed and manufactured under the name of “AID” by Medrad/Intec Systems in Pittsburgh, PA.
It was encased in titanium and hermetically sealed with a laser beam weld. It had a volume of 145 ml and weighed 250 gm. The device was powered by lithium batteries which had a projected monitoring life of 3 years or a discharge capability of 100 shocks.
The ICD was designed to detect ventricular fibrillation and sinusoidal ventricular tachycardia, and it attempted to using a truncated exponential 25 Joules pulse. The device could recycle three times during a single episode with the third and fourth pulses delivered at 30 Joules.
The device was meant to be connected to electrodes made from titanium and coated with silicone rubber. One defibrillating electrode was located intravascularly in the superior vena cava (SVC) at the right atrial junction. The second electrode had the configuration of a rectangular patch or a cup and was positioned over the cardiac apex.
First implants of the device were conducted at the Johns Hopkins Hospital in Baltimore in 1980. These devices were not programmable and manufactured on an individual basis. The AID was then improved with rate-counting circuitry and could synchronize shocks with the R-wave. Efforts were also made to reduce the recycling time after a failed shock. The new device was called the AID-B (shown in the picture), but was still manufactured according to individual specifications.
Acknowledgement: Thanks to Tim Carroll and Randy Armstrong at Velentium for allowing me to take a picture of this device in their collection.
Abbott today announced that the FDA has approved its next-generation Gallant™ line of ICD and CRT-D devices. According to the announcement:
“The devices bring new benefits to patients with heart rhythm disorders, including a patient-preferred design without compromising battery longevity and MRI compatibility. In addition, the new devices offer Bluetooth technology and a new patient smartphone app for improved remote monitoring, allowing for increased patient/physician engagement and streamlined communications.
The new Gallant system pairs with Abbott’s secure myMerlinPulse™, an iOS- and Android™- compatible mobile smartphone app that helps streamline communication between doctors and their patients. The app provides people with access to data, device performance, and transmission history, which helps them take an active role in their healthcare. Through the myMerlinPulse app, physicians can continuously monitor their patients remotely allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden.”
Abbott received the CE Mark for these devices back in February 2020.
Boston Scientific presented the final results from the UNTOUCHED study of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System presented at HRS 2020 SCIENCE.
The global, prospective, non-randomized UNTOUCHED study evaluated the safety and efficacy of the EMBLEM S-ICD System for primary prevention of SCD, specifically in patients with a LVEF ≤35%.
Data demonstrated S-ICD therapy had an inappropriate shock-free rate of 95.9% at 18-months post-procedure, meeting the primary endpoint with a rate comparable to or lower than those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies, conclusively showing high efficacy and safety of the EMBLEM S-ICD for patients without pacing indications.
Results for the investigator-sponsored, prospective, randomized, head-to-head PRAETORIAN trial using the EMBLEM S-ICD were also presented, indicating that the S-ICD can be the preferred therapy choice for the majority of ICD-indicated patients without a need for pacing as it offers comparable performance while avoiding lead-related complications and serious infections associated with TV-ICDs.
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 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.”
I just came back from HRS 2019 in SF, and the implantable devices buzz this year was around leadless pacemakers and defibrillators. Most importantly, they are no longer considered a technical curiosity, but rather are entering the mainstream as a serious alternative to leaded devices.
In the bradycardia field, Medtronic showed how their MICRA™- the only commercially-available leadless pacemaker at this time – is able to pace the ventricle in sequence with the atrium through the use of a 3D accelerometer that senses the atrial contraction.
Researchers using the Boston Scientific EMPOWER™ Modular Pacing System showed how it can communicate with Boston’s EMBLEM™ S-ICD System to provide brady and ATP pacing.
On its side, Abbott is said to be working to relaunch the plagued NANOSTIM™ leadless pacemaker after early battery depletion issues caused St. Jude to issue an advisory in October 2016, followed by Abbott maintaining the worldwide halt on implantations because of problems with the device’s docking button.
More mention is also being made of EBR’s LV pacemakers as an alternative to GCV leads to deliver CRT.
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.”
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.
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
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
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.
Abbott released a very nice video on the (St Jude Medical) CONFIRM Rx Implantable Loop Recorder (ILR):
An interesting interview with Avi Fischer, M.D., divisional vice president and medical director of Abbott’s cardiac rhythm management business about the impact of the CONFIRM Rx Implantable Cardiac Monitor was published today by Medgadget.
Cardialen, Inc. is a private company based in Minneapolis, MN. It was established in 2008 to develop an implantable defibrillator using low-electrical energy to restore normal heart rhythm and potentially avoid the negative side-effects of high-energy cardioversion shocks. The therapy is based on work by bioengineer Igor Efimov, whose federally-funded laboratory at George Washington University developed a way to defibrillate the heart without high-voltage shocks. Known as “unpinning termination” (UPT), the technique involves using a precisely timed series of low-voltage pulses to terminate an arrhythmia.
On October 2018 Cardialen announced that it had raised $17 million in a Series B funding round toward its goal. Cardialen stated that this funding would be used to continue clinical testing of the UPT concept in humans, and to start development of an implantable device to deliver the therapy.
Cardialen’s website: http://www.cardialen.com/
Medtronic states in the press release: “Second quarter revenue from Implantable Cardioverter Defibrillators (ICDs) was $713 million, an increase of 4 percent on a constant currency basis in a market that continues to show a trend toward stabilization. Pacing revenue was $477 million, an increase of 2 percent on a constant currency basis.”
On related news from the release: “Neuromodulation revenue of $479 million increased 6 percent on both a constant currency and an as reported basis. Growth was driven by strong performance from Activa® deep brain stimulation systems, as well as the launch of the RestoreSensor® SureScan® MRI spinal cord stimulator in the United States.”