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

Category Archives: Cardiac Pacing

Cardiac pacemakers

Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI

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

Iforia MRI-compatible ICD/CRT CRT-D David Prutchi PhD www.implantable-device.comBiotronik announced that it had received CE-approval for the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, this series contains one of the world’s smallest ICDs– the Iforia single chamber ICD.

Aside from featuring ProMRI®technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector system, which is designed to simplify and shorten the implantation procedure. The DF4 connector combines the traditional three connectors into one, allowing for a more convenient implantation procedure without compromising safety.

Click here for the press release.

Boston Scientific Defibrillators Receive CE Mark for 10-Year Longevity Projections

Posted on by Posted in AIMD Business, Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Power Sources, Tachycardia

 

Boston Scientific Incepta ICD with DF-4 connector

Image Credit: Boston Scientific

Boston Scientific has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings.

Projected device longevity exceeds 10 years for some models, approaches eight years for its CRT-D devices, and according to the press release is up to double that of comparable competitive device models. The company supports these devices with warranties of up to 10 years:

Warranties: INCEPTA and ENERGEN VR ICD: 10 years; INCEPTA and ENERGEN DR ICD: eight years; PUNCTUA and TELIGEN ICD: seven years; INCEPTA and ENERGEN CRT-D: six years; and PUNCTUA & COGNIS CRT-D: five years.

Continue reading→

Boston Scientific Receives CE Mark for RELIANCE® 4-FRONT™ Defibrillation Lead

Posted on by Posted in Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia
Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Defibrillation Lead www.implantable-device.com David Prutchi, Ph.D.

Image Credit: Boston Scientific

Boston Scientific has received regulatory approval to market the RELIANCE® 4-FRONT™ lead, its next generation implantable defibrillation lead now available in Europe and Asia.   According to the press release, “The RELIANCE 4-FRONT lead is built upon the demonstrated performance and reliability of the RELIANCE lead platform with design enhancements intended to simplify the implant procedure. With more than 350,000 implants worldwide, RELIANCE leads have demonstrated a 98.9 percent survival probability at 8 years.

“Leveraging the RELIANCE platform, we made a series of targeted design enhancements with RELIANCE 4-FRONT to improve and simplify implantation,” said Kenneth Stein, M.D., chief medical officer of Boston Scientific’s Cardiac Rhythm Management Group. “RELIANCE 4-FRONT represents our continued dedication to product innovation to meet the needs of patients and physicians.”

Continue reading→

One for History Buffs: Pacemaker Made in Brasil

Posted on by Posted in Bradycardia, Cardiac Pacing, CCC del Uruguay, CCC Medical, Museum

Implantable Pacemaker Made in Brasil. www.implantable-device.com David Prutchi Ph.D.

My friend Daniel Villamil from CCC Medical in Uruguay sent me these pictures of a very unique device in his colection.  It is a late-1960s/early 1970s pacemaker made in Sao Paulo, Brasil.

UPDATE Oct 3, 2012:

CCC’s CEO Julio Arzuaga recalled that this pacemaker was manufactured in the early 1960s by the Instituto de Cardiologia Dante Pazzanese in Sao Paulo, Brasil.  The physicians leading the pacemaker team were Dr. Decio Kormann and Dr. Adib Jatene.

Dr. Orestes Fiandra used to implant these Brasilian pacemakers in Uruguay.  However, they were not very reliable.  For this reason, and with help from Drs. Kormann and Jatene, Dr. Fiandra started CCC del Uruguay as a more industrial environment for the production of pacemakers.

Implantable Pacemaker Made in Brasil. www.implantable-device.com David Prutchi Ph.D.

St. Jude Starts Trial of Accent MRI Pacemaker and Tendril MRI Lead

Posted on by Posted in Bradycardia, Cardiac Pacing, MRI-safe, St. Jude Medical
St Jude's ACCENT MRI MRI-compatible pacemaker. Report by David Prutchi PhD

Image Credit: St. Jude Medical

Today St. Jude announced the first implant in its Accent MRI(R) Pacemaker and Tendril MRI(R) Lead IDE Study (MRI Study). The ultimate goal of the study is to determine if patients with these devices can safely undergo full-body, high resolution Magnetic Resonance Imaging (MRI) scans to better accommodate their medical needs. The investigational Accent MRI Pacemaker system from St. Jude Medical offers an advanced pacing platform that provides wireless telemetry and algorithms to help address individual patient conditions.

Continue reading→

Digikon’s History

Posted on by Posted in Bradycardia, Cardiac Pacing, Digikon, History, Museum

Digikon model LD451 Ventricular Inhibited Pulse GeneratorIn response to my post “A Challenge to History Buffs:  Who Was Digikon?“, Paolo Pagani sent me the following message:

“Digikon was in the years 1977-1985 the brand name product in Italy by Biotec Biomedical Technologies of Bologna – ITALY.

Pacemakers were a Digikon O.E.M. production for the trading company of Milan Italy KONTRON already a distributor in Italy of Medtronic.

Biotec developed the first pacemaker VVIR based on physiological changes in thoracic impedance due to respiration. (Biotec RDP-3)

Biotec-Bologna was acquired by Medtronic in August 1985.”

Thank you Paolo!

 

St. Jude Warns Physicians of Potential Problem with QuickSite and QuickFlex LV CRT Leads

Posted on by Posted in Cardiac Pacing, Heart Failure (CHF), St. Jude Medical
St Jude QuickFlex lead

Image Credit: St. Jude Medical

St. Jude announced it is proactively informing physicians about visual observations of externalized conductors on the silicone end of QuickSite® and QuickFlex® Left-Ventricular Leads, used to connect Cardiac Resynchronization Therapy devices to the heart.

The announcement noted that there have been no reports of patient injury or loss of therapy due to externalized conductors in these leads, but as a conservative measure, St. Jude Medical is communicating with physicians about the incidence rate so they have the most updated lead performance information with which to make important patient care decisions.

According to the announcement, “St. Jude Medical has confirmed 39 cases of externalized conductors, out of 171,000 QuickSite and QuickFlex leads sold worldwide, resulting in a current reported incidence rate of 0.023 percent, or 2.3 in 10,000. Because these leads continue to function normally, the company expects that this rate is under-reported. Based on an analysis of leads returned to the company and recent fluoroscopic images of implanted leads still in clinical use, St. Jude Medical estimates that 3 to 4 percent of QuickSite and QuickFlex leads may exhibit externalized conductors. As a result of this estimated rate, the company felt it was prudent to communicate with physicians about the externalized conductors at this time.”

St. Jude also announced they will no longer sell these lead models.

St. Jude Medical Announces Clinical Benefits of Quadripolar CRT Pacing at ACC

Posted on by Posted in Cardiac Pacing, Heart Failure (CHF), St. Jude Medical
Quadrapolar cardiac resynchronization pacing St Jude Medical Unify Quadra www.implantable-device.com

Image Credit: St. Jude Medical

St. Jude Medical announced that clinical findings on quadripolar pacing will be presented at the 61st Annual Scientific Sessions of the American College of Cardiology (ACC, Chicago, March 24-27 2012).

According to St. Jude’s announcement, quadripolar pacing allows physicians the ability to use multisite left-ventricular (LV) pacing.  Studies that examined the role of multisite pacing in improving hemodynamics and reducing dyssynchrony as compared to traditional bi-ventricular pacing will be presented in the following two posters:

Continue reading→

Medtronic Receives CE Mark for CapSure Sense MRI™ SureScan® Pacing Leads

Posted on by Posted in Cardiac Pacing, Medtronic, MRI-safe
Medtronic SureScan Sense MRI Passive Fixation Leads. www.implantable-device.com

Image Credit: Medtronic

Medtronic today announced the receipt of CE Mark and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during MRI procedures.  The newly approved leads are the smallest MR–Conditional leads available in the world with a 5.3 French isodiametric lead body.  The new leads are passive-fixation leads.  Previously approved Medtronic MR–Conditional leads are active fixation leads.

Click here for Medtronic’s product page for the CapSure Sense MRI™ SureScan® Pacing Leads.

iPacemaker Implantable Pacemaker/ICD Database for the iPhone

Posted on by Posted in Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), News, Tachycardia
iPacemaker implantable pacemaker and ICD database for the iPhone

Image Credit: iPacemaker

My friend and colleague Dr. Irit Yaniv alerted me to this iPhone app that was just released.  It is an implantable pacemaker and defibrillator database that, according to its author, displays up to 70 parameters for each model, includes battery and longevity data, and links directly to product manuals. Continue reading→

The Australian Pacemaker: Telectronics (1965-1995)

Posted on by Posted in Bradycardia, Cardiac Pacing, History, Museum, St. Jude Medical, Telectronics (1965-1995)

Telectronics model 150B VVI pacemaker photographed by David Prutchi, Ph.D. www.implantable-device.comIn 1965, Australian medical device pioneer Noel Gray established Telectronics – Australia’s first manufacturing facility for producing pacemakers that were designed in-house.  Telectronics was an innovative developer, achieving some major successes in the early cardiac pacing field, for example, Telectronics’ leads allowed narrowing the pacing pulse to its current nominal of 0.5 milliseconds; encapsulating the pacemaker in titanium instead of epoxy; using a microplasma weld to join the two halves of the pacemaker capsule; creating one of the first rate-responsive ‘demand’ pacemakers; and isolating the pacemaker’s battery in a separate compartment to deal with the problem of leaking mercury-zinc batteries. Continue reading→

Elema-Schoenander and the Very First Human Implants of a Pacemaker in Sweden (1958) and Uruguay (1960)

Posted on by Posted in Bradycardia, Cardiac Pacing, CCC del Uruguay, Elema-Schonander (-1959), History, Museum, Pacesetter, Siemens-Elema (1959-1994), St. Jude Medical

First pacemaker to be implanted in a human patient (1958)

This is a picture of the first pacemaker to be implanted in a human patient.  It was developed by Dr. Rune Elmqvist (1906–1996), a physician by training, but working for the Swedish company Elema-Schonander as an engineer.   Dr. Elmqvist  developed the device in cooperation of Åke Senning, senior physician and cardiac surgeon at the Karolinska University Hospital in Solna, Sweden. Continue reading→

Crazy Pacemaker Hack: d.i.y. High-Speed Photography

Posted on by Posted in Cardiac Pacing, My Portfolio, Tech Talk

High speed photography by David Prutchi using pacemaker as interval timer

This is a hack that combines three of my favorite passions: pacemakers, photography, and coffee!

I took this photograph by feeding the output of an infrared barrier to the atrium input of an old DDD pacemaker, setting an appropriate AV delay, and using the ventricular output to trigger a camera flash (via a optoisolator).  In a darkened room, I opened my camera’s shutter for 2 seconds.  I then let one drop of milk fall through the infrared barrier, starting the AV delay in VAT mode.  The flash then fires as the drop enters the coffee in the cup, freezing the action. Continue reading→

Intermedics’ First Pacemakers (Mid 1970s)

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

Intermedics InterLith Pacemakers from the mid-1970s

In 1973, former Medtronic sales representative Albert Beutel founded Intermedics in Freeport, TX.  The first product was a small, mercury-cell-powered pacemaker.  In 1974 Intermedics introduced a lithium-powered version, and in 1976 it introduced InterLith which was hermetically sealed, and weighed just 65 grams.  At the time, InterLith’s size was a breakthrough, and became a very popular device, solidifying Intermedics’ position in the industry.