The SYNERGY Circulatory Support System is a micro-blood pump that provides up to 4.25 liters of blood per minute and reduces the heart’s workload, while improving blood flow to vital organs. The system is surgically implanted using a mini-thoracotomy and the micro-pump is placed in a pacemaker-like pocket. The system’s less invasive procedure is intended to reduce the surgical risks associated with cardiopulmonary bypass support. In addition, SYNERGY is intended to reduce rehospitalizations associated with heart failure symptoms. SYNERGY is designed and manufactured in Aachen, Germany.
Category Archives: Heart Failure (CHF)
Implantable devices for the treatment of Congestive Heart Failure (CHF)
Boston Scientific Defibrillators Receive CE Mark for 10-Year Longevity Projections
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.
Boston Scientific Receives CE Mark for RELIANCE® 4-FRONT™ Defibrillation Lead
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.”
FDA Approves St. Jude’s Assura™ ICDs That Reduce Inappropriate Shocks
Image Credit: St. Jude Medical
St. Jude Medical today announced FDA approval of its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).The new implantable defibrillators feature SecureSense™ RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients with these devices.
According to St. Jude’s announcement:
St. Jude Warns Physicians of Potential Problem with QuickSite and QuickFlex LV CRT Leads
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
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:
iPacemaker Implantable Pacemaker/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
Remon Medical’s Implantable Pulmonary Pressure Sensor (1997-2007)
Remon Medical Technologies, Ltd. was founded in 1997 in Caesarea, Israel to develop implantable, wireless pressure sensors.
Remon developed an implantable hemodynamic monitor, which allowed on-demand, non-invasive, leadless self-monitoring of pulmonary artery pressure by the patient at home. ImPressure devices were placed in the pulmonary artery, and transmitted pressure readings to a hand-held monitor. It was hoped that the system would provide early warning of the need for treatment, avoiding hospitalization and deterioration in the patient’s condition. Continue reading
Medtronic’s Chronicle Implantable Hemodynamic Monitor for Heart Failure Monitoring
- Image Credit: Medtronic
The Medtronic Chronicle implantable hemodynamic monitor used a specialized RV lead/sensor. The device was able to monitor and telemeter:
- Systolic and diastolic pressure
- Estimated pulmonary artery diastolic pressure
- RV dp/dt (positive & negative)
- Heart rate & activity
- Core body temperature
- Continuous remote monitoring
- Continue reading
CardioMEMS Miniature Implantable Wireless Sensors
CardioMEMS was founded by Dr. Jay S. Yadav and Dr. Mark G. Allen in Atlanta, GA in 2000 to develop implantable micro-electromechanical sensors to improve the management of severe chronic cardiovascular diseases such as heart failure and aneurysms.
The miniature wireless sensors can be delivered through a catheter. Once in place, they transmit cardiac output, blood pressure and heart rate data that are critical to the management of patients. Due to their small size, durability, and lack of wires and batteries, CardioMEMS’ sensors are designed to be permanently implanted into the cardiovascular system. An external reader is used to interrogate the sensors. Continue reading
BioControl’s CardioFit System for the Treatment of Heart Failure via Vagus Nerve Stimulation
BioControl Medical, Ltd. was founded in 1999 by Yossi Gross, and is based in Yehud, Israel. BioControl’s first devices were developed to treat incontinence due to overactive bladder, stress, and interstitial cystitis. In 2006 American Medical Sytems acquired an exclusive license for the use of the technology in urology, gynecology and other pelvic health applications. Continue reading
EBR System’s Wireless Pacemaker
EBR Systems, Inc., founded in 2003 and headquartered in Sunnyvale, CA, is developing the WiCS® Wireless Cardiac Stimulation technology to eliminate cardiac pacing leads, historically a major source of complications and reliability issues. The startup was spun out of research by founder Debra Echt, a former professor of medicine and a cardiologist at Vanderbilt University. Continue reading
Enopace Biomedical
From Patent Application Publication: US 2011/0137370 A1
Enopace Biomedical Ltd. was founded in 2008 by Yossi Gross in Caesarea, Israel.
Very scant details are available besides that it is developing a neuromodulation system to treat patients with congestive heart failure. According to the company, its technology consists of a minimally invasive, implantable neurostimulation device that increases cardiac efficiency by reducing left ventricular workload.
From Enopace’s patent applications, it seems that Enopace’s device consists of a stimulation unit that is placed within the aorta close to the heart, and which is driven wirelessly from a coil that is placed within a vein closeby to the artery. The transmitting coil is in turn driven from an implanted control unit that is implanted subcutaneously. Continue reading
Respicardia’s remedē Implantable Device for the Treatment of Central Sleep Apnea
Image Credit: Respicardia
Respicardia, Inc. (formerly Cardiac Concepts, Inc.) is a privately held medical device company incorporated in 2006. It is located in Minneapolis, Minnesota, USA. It is developing an implantable system intended to improve the outcomes for Heart Failure patients by developing an implantable stimulation therapy to treat Central Sleep Apnea.
The remedē System is an implantable medical device that is being investigated in a clinical research study for the treatment of Central Sleep Apnea in patients with Heart Failure. It consists of three implantable components:
- remedē Pulse Generator comprised of electronic circuitry components and a battery, which are hermetically sealed in a titanium case
- remedē Stimulation Lead that is implanted in a vein close to one of the phrenic nerves
- a sensing lead to detect respiration Continue reading
Angel Medical’s Guardian Implantable Heart Attack Monitor
Photo Credit: PRNewsFoto/Angel Medical Systems
Angel Medical was founded by Dr. Robert E. Fischell and Dr. David R. Fischell. The AngelMed Guardian® system is an implantable cardiac device, designed to detect rapid ST segment shifts that may signify major cardiac events, such as coronary artery occlusions caused by life-threatening vulnerable plaque ruptures. Once an ST shift is detected, the system is designed to alert patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings. The AngelMed Guardian system is intended to address the challenge of patients not recognizing nor responding quickly to heart attacks. Continue reading