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

Category Archives: Cardiac Pacing

Cardiac pacemakers

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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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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St. Jude Launches Allure Quadra™ CRT-P IPG with Quadripolar Lead Technology

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

St. Jude Launches Allure Quadra™ CRT-P IPG with Quadripolar Lead TechnologySt. Jude Medical today announced CE Mark approval and European launch of its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which brings the quadripolar lead technology to the pacemaker market for the first time.  According to the press release:

“Quadripolar leads allow for increased implant efficiencies, which clinical data indicates can result in fewer surgical revisions. The Allure family of devices also offer enhanced heart failure (HF) diagnostics, including CorVue™ Impedance Monitoring, for improved patient management.

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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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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.

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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.”

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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.

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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.