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.
St. 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)
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
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
Biotronik 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
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
Sorin Receives Conditional FDA IDE Approval to Study its Paradym CRT-D IPG and SonRtip Hemodynamic Sensor Lead
Sorin 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,
Biotronik 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
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.
On Sept. 28, 2012 Boston Scientific announced that the FDA granted regulatory approval for its S-ICD® System, the world’s first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System sits entirely just below the skin without the need for leads to be
In this TED talk, Hugo Campos explains his frustration with the fact that his ICD collects data, but he – as a patient – is unable to access these data as a diagnostic tool to help make good choices about eating, exercise and other activities.
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 Seeks Retraction of Heart Rhythm Journal Manuscript by Dr. Robert Hauser Regarding the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads
St. Jude announced it is seeking a retraction of the manuscript accepted for publication in the Heart Rhythm Journal by Dr. Robert Hauser, et al., titled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.” St. Jude claims that the research performed by Hauser undercounted and excluded MAUDE data reports for
Boston Scientific announced the exercise of its option to acquire Cameron Health. Cameron Health developed the world’s first and only commercially-available subcutaneous implantable cardioverter defibrillator – the S-ICD® System that I blogged about a few weeks ago. The agreement calls for an upfront payment of $150 million, payable upon transaction closing, an additional potential $150