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
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.
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
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
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
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.
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
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
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
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.
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.
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
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
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
Yossi Gross (born February 5, 1947) is an Israeli medical device innovator and entrepreneur. His medical-device companies are incubated through Rainbow Medical. Currently, the following companies led by Yossi Gross are focusing on active implantable medical devices: BetaStim, developing a new neurostimulation treatment for diabetes Brainsgate, developing an implantable device for acute stroke treatment and brain