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

Category Archives: Bradycardia

Implantable devices for the treatment of bradycardia (pacemakers)

Historical Piece: Intermedics’ C-MOS-I Mercury-Cell Pacemaker (1973)

Posted on by Posted in Bradycardia, Cardiac Pacing, Intermedics (1974-1999), Museum

Intermedics C-MOS-I Pacemaker. Image credit: Michael Sklanowsky

In 1973, former Medtronic sales representative Albert Beutel founded Intermedics in Freeport, TX. The company’s first product was the C-MOS-I implantable pulse generator – a small (for the time), mercury-cell-powered pacemaker.

Mike Sklanowsky shared pictures of a C-MOS-I sample that he owns.  Mike was a software consultant to Intermedics in Freeport around 1974, where he developed the first computerized pacemaker tracking and product recall software.  Through his software, Intermedics tracked pacemaker  locations and movement through distribution warehouse shelves, hospitals, clinics, doctors, nurses, patient notification of expiring battery charge, product recall communications, follow-ups, etc.

Before Intermedics, Mike worked for JPL, which was his first full-time job upon graduating from UCLA.  At JPL he worked on problems related to celestial mechanics, spacecraft orbit determination, trajectory analysis, instrument operations, and human interfaces for real-time command and control.  His first project was Mariner 9 Mars, which became the first man-made satellite to orbit another planet.

Mike, and fellow UCLA graduate Bob Patterson were the only two people from their class to get hired by JPL.  Bob’s mentor, Prof. Ken Nobe involved both with Intermedics.  Dr. Robert (Bob) Patterson was an expert in long-life lithium battery technology for space exploration, and his work for Intermedics led to the 1974 development of a lithium-powered version of C-MOS-I, followed in 1976 by InterLith which was hermetically sealed, and weighed just 65 grams.

FDA Clears Vital Data Sensor in Biotronik’s Biomonitor IIIm ICM

Posted on by Posted in Atrial Flutter/Fib, Biotronik, Bradycardia, ECG Monitoring

Image Credit: Biotronik

FDA has cleared Biotronik’s Vital Data Sensor to identify body temperature increases potentially associated with fever as part of its new Biomonitor IIIm injectable cardiac monitor (ICM).

The device has shown to achieve a 72 percent reduction in false positives while maintaining 100 percent of AF-related sensitivity. It removes single ectopic beats out of the AF detection algorithm, enhancing diagnostic accuracy.

According to Biotronik, “BIOMONITOR IIIm is the industry leader in battery longevity with 5.5 years of continuous service, providing long-term post-ablation or cryptogenic stroke monitoring. It is also backed by the Patient App, which allows patients to include vital symptom data, providing physicians with symptom-rhythm correlation which strengthens diagnostic precision.”

What Happens When Fido Needs a Pacemaker?

Posted on by Posted in Bradycardia, Cardiac Pacing, Dextronix, Infinity Medical, Veterinary Use

Pets are prone to the same type of electrophysiological anomalies as humans, and pacemakers are often implanted to resolve bradycardia.  Implants happen most commonly in dogs, but have also been used to treat cats and ferrets.

The dog breeds that most often have electrophysiological issues that can be treated with pacemakers are Miniature Schnauzers and West Highland White Terriers (typically for sick sinus syndrome), German Shepherds and Labrador Retrievers (typically for third degree AV block).

Human-use pacemakers (including resterilized devices explanted from patients who have passed away) are often used, but there are at least two brands of devices made specifically for veterinary use:

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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.”

 

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.”

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.

Medtronic Performs First Human Implant of its Micra Leadless Pacemaker

Posted on by Posted in Bradycardia, Cardiac Pacing, Medtronic

Medtronic Micra TPS leadless wireless pacemaker www.implantable-device.com David Prutchi PhD

 

According to the press release:

At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned if needed. The miniature device does not require the use of wires, known as “leads,” to connect to the heart. Attached to the heart via small tines, the pacemaker delivers electrical impulses that pace the heart through an electrode at the end of the device.

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Sorin Announces CE Mark and Implant of its MRI-Compatible Kora 100 Pacemaker with Automatic MRI Mode

Posted on by Posted in Bradycardia, Cardiac Pacing, MRI-safe, Sorin

Sorin Kora 100 MRI pacemaker David Prutchi PhD www.implantable-device.com

Sorin announced the CE Mark approval and first implant of its KORA 100 pacing system.

According to the press release:

KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging (MRI) safely.[1] Pacemaker patients are typically older than 65 years. This patient population is prone to other medical conditions such as arthritis, cancer or stroke that may require MRI examinations for optimal diagnosis and management.

The KORA 100 pacing system has been designed with both patients and physicians in mind. Device settings which allow safe operation during an MRI examination are automatically enabled when KORA 100 pacemakers detect the scanner’s magnetic field. Similarly the devices sense when a patient leaves the MRI field, and return to normal operation within five minutes. The Automatic MRI Mode feature, which is patented and available exclusively on Sorin Group pacemakers, limits the amount of time that KORA 100 pacemakers operate in MRI mode.

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Medtronic Advisa and Revo MRI SureScan Pacemakers Delays Atrial Fibrillation Disease Progression

Posted on by Posted in Atrial Flutter/Fib, Bradycardia, Cardiac Pacing, Medtronic

Medtronic Advisa www.implantable-device.com David Prutchi PhD

Results for the MINERVA Trial were presented at the AHA Meeting, showing that  Medtronic Advisa and Revo MRI(TM) SureScan(TM) pacemakers reduce the progression of permanent AF by 61%.  According to the press release:

Presented as a late breaking clinical trial at the American Heart Association’s Scientific Sessions 2013, the MINERVA (MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure) study found that Medtronic pacemakers with atrial antitachycardia pacing (Reactive ATP(TM)), managed ventricular pacing (MVP®) and atrial intervention features were able to significantly decrease the incidence of mortality, cardiovascular hospitalizations or permanent AF at two years compared to pacemakers without these features. The effects of these features were most evident by a significant delay in the progression of atrial tachyarrhythmias to permanent AF, with a 61 percent relative risk reduction at two years.

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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 Acquires Nanostim, Announces CE Mark of World’s First Leadless Pacemaker

Posted on by Posted in AIMD Business, Bradycardia, Cardiac Pacing, Nanostim, St. Jude Medical

cbhayden@me.com

St. Jude Medical today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio.

httpv://youtu.be/P6PLiyzatOo

According to the press release:

Unlike conventional pacemakers that require a more invasive surgery, the Nanostim™ leadless pacemaker is designed to be implanted directly into the heart via a minimally invasive procedure. The device is delivered using a steerable catheter through the femoral vein, eliminating the need to surgically create a pocket for the pacemaker and insulated wires (called leads) that have historically been recognized as the most vulnerable component of pacing systems. The Nanostim leadless pacemaker recently received CE Mark approval and will be available soon in select European markets. It also recently received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating Nanostim leadless technology in the U.S.

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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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Sorin Launches Reply 200 Pacemakers with Sleep Apnea Monitoring

Posted on by Posted in Bradycardia, Cardiac Pacing, Sleep Apnea, Sorin

Sorin Reply 200 with apnea monitor David Prutchi PhD www.implantable-device.comSorin announced today CE mark approval and the European commercial launch of the REPLY ™ 200 family of pacemakers featuring Sleep Apnea Monitoring (SAM).  According to the press release:

Sleep apnea is highly prevalent and vastly undiagnosed in pacemaker patients. It increases the mortality risk and the risk of common cardiovascular co-morbidities such as hypertension, atrial fibrillation (AF) and heart failure (HF). Moreover, sleep apnea complicates the management of common cardiovascular co-morbidities.

The REPLY 200 SR and DR pacemakers automatically screen patients for the risk of severe sleep apnea using a highly reliable sensor that measures ventilation. The Respiratory Disturbance Index (RDI), calculated and reported by the pacemaker, has been validated against polysomnography, the gold standard method used to diagnose sleep apnea.

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