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

Category Archives: Tachycardia

Implantable devices for the treatment of ventricular tachycardia and fibrillation (Implantable Cardioverter Defibrillators – ICDs)

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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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.

Nice Abbott Video on CONFIRM Rx ILR

Posted on by Posted in Abbott, Atrial Flutter/Fib, Bradycardia, ECG Monitoring, St. Jude Medical, Tachycardia

Image Credit: Abbott

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’s Unpinning Termination Antiarrhythmic Therapy

Posted on by Posted in Atrial Flutter/Fib, Cardialen, Tachycardia

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 Reports CRM AIMD Sales Trend Showing Stabilization + Strong Earnings from Neuromodulation AIMDs

Posted on by Posted in AIMD Business, Bradycardia, Brain Stimulation, Medtronic, Pain, Spinal Cord Stimulation, Tachycardia

Medtronic_LogoMedtronic released today its earning reports for the second quarter of fiscal year 2014, which ended October 25, 2013.

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.”

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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Biotronik Receives FDA Approval for Ilesto 7 ICD/CRT-D Series

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

Biotronik Ilesto ICD CRTD David Prutchi PhD www.implantable-device.comBiotronik announced that FDA granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. According to the press release:

“BIOTRONIK lives up to its reputation for excellence in design and manufacturing with the introduction of the Ilesto family, and the new Ilesto DX device. Physicians depend on complete and timely information, and Ilesto DX with BIOTRONIK Home Monitoring® certainly delivers. With this device, physicians can receive atrial information to ensure diagnostic accuracy and identify previously undetected atrial fibrillation. They also receive peace of mind that there is less risk of complications due to the single lead,” said Paul Woodstock, executive vice president of sales and marketing at BIOTRONIK, Inc., USA. “Ilesto’s smaller footprint will be more comfortable as well, which may present a win-win solution for patients and physicians alike.”

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Medtronic Announces FDA Approval of Next-Generation CRT-D and ICD IPG Families

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

Medtronic Evera ICD www.implantable-device.com David Prutchi PhD

Medtronic announced today the FDA approval of its new Viva® portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).  According to the press release:

“The Viva CRT-D significantly improves response rate to the therapy for many indicated heart failure patients, with a demonstrated 21 percent reduction in overall heart failure hospitalizations within the first year after implant as compared to historical CRT trials. According to economic analyses presented at ISPOR Europe, with this device both payers and hospital providers will experience reductions in overall healthcare costs as compared to CRT-D devices with traditional programming.

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Sorin Receives Conditional FDA IDE Approval to Study its Paradym CRT-D IPG and SonRtip Hemodynamic Sensor Lead

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

Sorin Paradym CRT-D David Prutchi PhD www.implantable-device.comSorin announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial that will enroll more than 1,000 patients in the United States and other geographies.

The SonR optimization system is comprised of the SonR hemodynamic sensor embedded in the SonRtip atrial pacing lead and the PARADYM RF SonR CRT-D device, which includes a unique algorithm to automatically optimize the patient’s atrioventricular (AV) delay and interventricular (VV) delay timing. While there are several CRT systems on the market, studies have shown that approximately one-third of patients with advanced heart failure do not effectively respond to CRT. The SonR system is the first and only CRT hemodynamic sensor based system designed to automatically adjust on a weekly basis. The timing of electrical impulses delivered to the heart is based on the patient’s heart activity and need – with the goal of improving the patient’s response to CRT. Typically this device re-programming is done manually in the clinic using echocardiography.

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