Cardiac 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:
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.”
BackBeat® Medical in New Hope, PA, a subsidiary of Orchestra BioMed, Inc. announced that it received the CE Mark for its Moderato® device. BackBeat’s Cardiac Neuromodulation Therapy (CNT) is a patented implantable cardiac stimulation-based treatment for hypertension that immediately and substantially lowers blood pressure. The stimulation algorithms in the Moderato® device are designed such that they simultaneously modulate autonomic nervous system responses that normally drive and maintain blood pressure higher. The Moderato® device also provides standard DDDR pacemaker functions.
The Cardiovascular Research Foundation (CRF) selected the MODERATO II clinical study for a late-breaking science presentation at TCT 2019 (September 28, 2019) by Karl-Heinz Kuck, MD., Ph.D., Director of Cardiology at the Lans Medicum, Hamburg, Germany and principal investigator for the MODERATO Studies.
The website for BackBeat is at: https://orchestrabiomed.com/technology/backbeat-cnt/
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’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.
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.
Image Credit: Medtronic
Medtronic announced today that it has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left heart lead, and is designed for precise lead placement and stability. Medtronic said that the lead will be commercially available in the U.S. in summer 2019.
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: 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.
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
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
Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA. There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation:
I can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it is documented by Kirk Jeffrey in “Machines in our Hearts”:
“In 1968, Robert Fischell, of the Applied Physics LOaboratory at Johns Hopkins University, and cardiologist Kenneth B. Lewis had begun a collaboration that led in 1973 to a new kind of Ni-Cad battery able to function more effectively at body temperature and hermetically sealable. Alfred E. Mann, a California entrepreneur with background in the aerospace industry, had provided some financial support to the Hopkins group. Eventually Mann founded a small company to develop a pacemaker for the rechargeable battery; this was the origin of Pacesetter Systems. The rechargeable pacemaker reached the market in the summer of 1973, just as CPI introduced its lithium pacer.”
![IMAGE_Nanostim_Product_Shot[1]](https://www.implantable-device.com/wp-content/uploads/2013/10/IMAGE_Nanostim_Product_Shot1.jpg)
St. Jude today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for FDA approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy. The LEADLESS II pivotal trial is a prospective, non-randomized, multi-center, international clinical research trial designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in patients indicated for the device. It is being conducted under an Investigational Device Exemption (IDE) from the FDA, and will enroll approximately 670 patients at 50 centers in the U.S., Canada and Europe.
According to the press release:
The Nanostim leadless pacemaker is designed to be placed directly in the heart without the visible surgical pocket, scar and insulated wires (called leads) required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device offers physicians the same pacing therapy through a less-invasive approach as compared to traditional pacemaker procedures that require more extensive surgery. The device is designed to be fully retrievable, so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.
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.