Implantable devices for the treatment of bradycardia (pacemakers)
Image Credit: Medtronic
Medtronic announced results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study showing that an investigational set of algorithms in the Micra™ leadless pacemaker improves synchrony and cardiac function in patients with atrioventricular (AV) block. Continue reading
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:
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.”
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.
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.”
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.
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.
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.
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.
Medtronic 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 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.
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.
St. 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.
Sorin 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.
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.
Biotronik 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.”