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

Category Archives: Cardiac Pacing

Cardiac pacemakers

St. Jude Implants First US Patient with its Nanostim Leadless Cardiac Pacemaker

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

IMAGE_Nanostim_Product_Shot[1]

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.

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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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European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure

Posted on by Posted in BioControl, Cardiac Pacing, Cardiac Stimulation (other), CardioMEMS, CVRx, Heart Failure (CHF), Impulse Dynamics, Spinal Cord Stimulation, Vagus Nerve Stimulation

Implantable devices for the treatment of heart failure, David Prutchi, PhD

 

A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association.

The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:

 Several new devices for the treatment of heart failure (HF) patients have been introduced and are increasingly used in clinical practice or are under clinical evaluation in either observational and/or randomized clinical trials. These devices include cardiac contractility modulation, spinal cord stimulation, carotid sinus nerve stimulation, cervical vagal stimulation, intracardiac atrioventricular nodal vagal stimulation, and implantable hemodynamic monitoring devices. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients.

The report places special focus to patients with HF New York Heart Association (NYHA) Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex (who are candidates for treatment with cardiac resynchronization therapy – CRT).

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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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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.

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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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TYRX receives FDA Approval for Fully Resorbable AIGISRx R Antibacterial IPG Envelope

Posted on by Posted in Cardiac Pacing, Cardioversion/Defibrillation, Drug Delivery, Infection, TYRX Inc

Tyrx IPG antimicrobial pouch David Prytchi www.implantable-device.com

AIGISRx® is an Antibacterial Envelope that is made from knitted polypropylene mesh substrate, coated with a polyarylate bioresorbable polymer containing two antimicrobial antibiotics, minocycline and rifampin. AIGISRx is a dual component (resorbable and non-resorbable), sterile prosthesis designed to reduce infection and to stabilize the implantable pacemaker or defibrillator when implanted in the body.

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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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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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