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 Medtronic product resulting in substantial factual errors.
According to the press release: Continue reading
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.
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:
FDA released its PMA/Supplement approvals for January. The edited version below has been edited to include only AIMDs. It is not the full list, and should be used only for general information purposes.
Magnetic reed switches are used in active implantable medical devices as a simple way of placing the device in a known operational mode when a programmer is not available. For example, placing a magnet on a pacemaker sets it to VVI mode with a manufacturer-specified set of parameters. In other devices (e.g. implantable cardioverter/defibrillators), placing a magnet on the IPG inhibits the delivery of high voltage defibrillation.
Although the reed switches that I use don’t come from Meder Electronics, I came across a very cool video that Meder produced regarding their manufacturing process. Continue reading
Image Credit: Imthera
ImThera Medical announced this week that it received the CE Mark for the Aura6000 System to Treat Obstructive Sleep Apnea. Continue reading
Image Credit: Boston Scientific
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 million payment upon FDA approval of the S-ICD System, plus up to an additional $1.050 billion of potential payments upon achievement of specified revenue-based milestones over a six-year period following FDA approval. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.
Image Credit: Medtronic
Medtronic today announced the receipt of CE Mark and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during MRI procedures. The newly approved leads are the smallest MR–Conditional leads available in the world with a 5.3 French isodiametric lead body. The new leads are passive-fixation leads. Previously approved Medtronic MR–Conditional leads are active fixation leads.
Click here for Medtronic’s product page for the CapSure Sense MRI™ SureScan® Pacing Leads.
Image Credit: Stanford University
Stanford Engineering assistant professor Ada Poon demonstrated a tiny, wirelessly powered, self-propelled medical device capable of controlled motion through blood. The device drives electrical current directly through the fluid, which in the presence of an external magnetic field creates a directional force that pushes the device forward. This type of device is capable of moving at just over half-a-centimeter per second.
That was the news picked up by bloggers from Poon’s presentation at the International Solid-State Circuits Conference (ISSCC). However, what caught my attention is her work on inductive transcutaneous energy transmission. From Stanford’s press release: Continue reading
Today Medtronic announced financial results for its third quarter of fiscal year 2012, which ended January 27, 2012. According to the report:
“CRDM third quarter revenue of $1.192 billion decreased 2 percent as reported or 3% on a constant currency basis. Third quarter revenue from ICDs was $674 million, down 9 percent on a constant currency basis, while pacing revenue was $467 million, an increase of 3 percent on a constant currency basis. Weaker ICD sales, primarily due to declining procedure volumes in the U.S. market versus the prior year, were partially offset by continued growth of the AF Solutions and Pacing businesses.”
…
“Neuromodulation revenue of $419 million increased 4 percent as reported and on a constant currency basis. Growth continues to be driven by strong sales of InterStim® Therapy. The RestoreSensor™ spinal cord stimulator with its proprietary AdaptiveStim™ technology continues to perform well in Europe, and was approved in the U.S. and Japan in the third quarter. The U.S. launch of this product was delayed for most of the quarter due to a supply disruption resulting from the flooding in Thailand, which has subsequently been resolved.”
Image Credit: MicroCHIPS, Inc.
Last month I posted some background on MicroCHIPS, the MIT spinoff to develop implantable sensors and drug-delivery devices. I concluded that post with the February 2011 announcement that MicroCHIPS started its clinical trial to assess the pharmacokinetics of long-term parathyroid hormone (hPTH 1-34) delivery in women with osteoporosis.
MicroCHIPS announced today the results of the first successful human clinical trial with an implantable, wirelessly controlled and programmable microchip-based drug delivery device. The MicroCHIPS study was published in today’s online edition of the journal Science Translational Medicine. Continue reading
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
In 1965, Australian medical device pioneer Noel Gray established Telectronics – Australia’s first manufacturing facility for producing pacemakers that were designed in-house. Telectronics was an innovative developer, achieving some major successes in the early cardiac pacing field, for example, Telectronics’ leads allowed narrowing the pacing pulse to its current nominal of 0.5 milliseconds; encapsulating the pacemaker in titanium instead of epoxy; using a microplasma weld to join the two halves of the pacemaker capsule; creating one of the first rate-responsive ‘demand’ pacemakers; and isolating the pacemaker’s battery in a separate compartment to deal with the problem of leaking mercury-zinc batteries. Continue reading
Image Credit: Micro Systems Technologies
Micro Systems Technologies (MST) is the vertically-integrated supplier of microelectronics and implantable-grade components to Biotronik. It now offers its development and manufacturing services to others.
Through its companies, MST offers high-reliability microelectronic modules for implantable medical devices such as pacemakers, defibrillators, neurostimulators, and cochlear implants.
MST can provide integrated solutions encompassing everything from conceptual design through high-volume surface-mount (SMT) assembly of modules. Services include design development of customer-defined electronic modules, custom ASIC design and development, and high-density-interconnect (HDI) substrate and assembly design.
As a OEM, MST offers state-of-the-art automated SMT line, an ISO 13485–compliant process and component verification and validation methodology, a manufacturing execution system that automates data collection, analysis, and process control, and comprehensive supply-chain management and monitoring with 100% traceability. Continue reading
Image Credit: VeriMed
On January 17, 2012, VeriTeQ Acquisition Corporation of Delray Beach, FL announced that it acquired the VeriChip implantable RFID technology and its related Health Link personal health record from PositiveID Corporation. Continue reading