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

Category Archives: Cardioversion/Defibrillation

ICDs

Boston Scientific’s EMBLEM™ S-ICD System Suggested as First-Line Therapy for ICD Patients without Pacing Indications

Posted on by Posted in Boston Scientific, Cardioversion/Defibrillation, Tachycardia

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 Initiates Worldwide Pivotal Study for its Extravascular ICD

Posted on by Posted in Cardiac Pacing, Cardioversion/Defibrillation, Medtronic, Tachycardia
Medtronic EV 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 Q1 FY2020: Cardiac Rhythm & Heart Failure Down 3.1%, Pain Therapies Down 7%

Posted on by Posted in AIMD Business, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Medtronic, Neural Stimulation, Pain, Spinal Cord Stimulation, Tachycardia, Uncategorized

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.”

 

Boston Scientific Reports Weak CRM and Neuromodulation Growth

Posted on by Posted in AIMD Business, Boston Scientific, Cardiac Pacing, Cardioversion/Defibrillation, Neural Stimulation

Boston Scientific Logo

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.

My take from HRS: Leadless Pacemakers are Entering the Mainstream

Posted on by Posted in Abbott, Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, EBR Systems, Heart Failure (CHF), Medtronic, Tachycardia

Medtronic Micra™, Boston Scientific Empower™, and St Jude (Abbott) Nanostim™. Scale is approximate

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.

EBR’s WISE wireless LV pacemaker is powered from an ultrasonic generator implanted outside the heart.

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Biotronik Launches Single-Pass Dual-Chamber Defibrillation System

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

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.”

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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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 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.

TYRX receives FDA Approval for Fully Resorbable AIGISRx R Antibacterial IPG Envelope

Posted on by Posted in Cardiac Pacing, Cardioversion/Defibrillation, Drug Delivery, Infection, TYRX Inc

Tyrx IPG antimicrobial pouch David Prytchi www.implantable-device.com

AIGISRx® is an Antibacterial Envelope that is made from knitted polypropylene mesh substrate, coated with a polyarylate bioresorbable polymer containing two antimicrobial antibiotics, minocycline and rifampin. AIGISRx is a dual component (resorbable and non-resorbable), sterile prosthesis designed to reduce infection and to stabilize the implantable pacemaker or defibrillator when implanted in the body.

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St Jude Receives CE Mark for Quadra Assura MP™ Multipoint CRT-D

Posted on by Posted in Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), St. Jude Medical, Tachycardia

SJM_QuadraAssuraMPSt. Jude Medical today announced CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D). The device features MultiPoint™ Pacing (MPP) technology that enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to best optimize cardiac resynchronization therapy (CRT) pacing to meet individual patient needs.

According to the press release:

The Quadra Assura MP CRT-D is designed to work with the Quartet™ Lead, which has four electrodes to offer maximum flexibility for different pacing configurations. The new MPP capability allows physicians to program simultaneous or sequential delivery of two left ventricular (LV) pulses per pacing cycle, rather than the standard single pacing pulse. The capability to deliver two LV pulses per cycle allows physicians to tailor CRT pacing for each patient, potentially leading to more effective outcomes compared to single site pacing, which may be particularly beneficial in patients not responding to traditional bi-ventricular pacing therapy.

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FDA Approves St. Jude’s Ellipse™ and SJM Assura™ Portfolio of ICDs and CRT-D Devices

Posted on by Posted in Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), St. Jude Medical, Tachycardia

St Jude Medical Assura Ellipse ICD CRT-D www.implantable-device.com David Prutchi PhD

St. Jude Medical announced FDA approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery.

According to the announcement:

The Ellipse and SJM Assura family of devices feature the DynamicTx™ Over-Current Detection Algorithm, which automatically adjusts shocking configurations to ensure the delivery of high-voltage therapy even if an electrical short in one portion of the system were to occur. In addition, the next-generation Ellipse and SJM Assura portfolio of implantable defibrillators have a low-friction coating on the device can, which has been demonstrated in testing to significantly reduce the friction between the device and leads. As such, the low-friction coating provides an extra layer of insulation and is designed to reduce the risk for lead-to-can abrasion, the most common type of lead insulation failure in the industry.

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Sorin Receives FDA Approval for SMARTVIEW™ Remote Monitoring Solution

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

Sorin Paradym Smartview www.implantable-device.com David Prutchi PhD

Sorin today announced it received FDA approval for and is beginning the U.S. launch of the SMARTVIEW™ remote monitoring solution for patients with CRM devices.  From the press release:

“Using the secure SMARTVIEW remote monitoring solution, physicians and nurses following patients with a Sorin PARADYMTM RF device can access valuable cardiac data and alert messages from the device while the patient is at home. Sorin launched the PARADYMTM RF VR and DR implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices in the United States in May 2012.

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