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.
Miniature, ultra-flexible electrode (credit: EPFL)
Aleva Neurotherapeutics is a spinoff of the Swiss Federal Institute of Technology (EPFL) Microsystems Laboratory. Aleva is developing unique microfabricated devices to more specifically target deep-brain stimulation.
kurtzweilai.net recently published an interesting blog about the technology. From the post:
“Miniature, ultra-flexible electrodes could be the answer to more successful treatment for Parkinson’s diseases, according to Professor Philippe Renaud of the École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland.
He has developed soft arrays of miniature electrodes in his Microsystems Laboratory that open new possibilities for more accurate and local deep brain stimulation (DBS).
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Mainstay Medical was founded in 2008 by entrepreneur Dr. Danny Sachs. The company’s ReActiv8 neurostimulator is intended to treat chronic low back pain caused by arthrogenic muscle inhibition. This is a neuroprotective condition in which the brain reflexively attempts to limit motor stimulation and movement in muscles surrounding a joint in response to damage or injury to the joint. In patients with this type of back pain, an initial injury triggers this reflexive inhibition, and the brain tries to limit painful movement by altering nerve transmissions to the deep stabilizing muscles of the spine, causing a loss of motor control, an unstable spine, and greater susceptibility to reinjury.
Neuros Medical, a Cleveland, Ohio based neuromodulation company, developed the Altius implantable system to deliver Electrical Nerve Block therapy for the treatment of chronic pain in a variety of applications including neuroma/residual limb pain, chronic post surgical pain, and chronic migraine.
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Medtronic’s press release:
MINNEAPOLIS – June 26, 2013 – In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
The United States Food and Drug Administration (FDA) has classified three of these notifications as Class I recalls.The fourth notification is an update to a 2011 action related to pump refill which was previously classified by the FDA as a Class I recall.
Patients are encouraged to maintain regular follow-up appointments with their physicians; however, if they experience a change or return of symptoms or hear a device alarm, they should contact their physician immediately. No action is required of physicians beyond the recommendations provided in the notifications.
Medtronic’s intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin. These notifications do not involve Medtronic external insulin pumps for diabetes.
Specifically, the Neuromodulation business of Medtronic has initiated the following field corrective actions:
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) 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.
Sorin 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.
Image Credit: Boston Scientific
Boston Scientific announced today the first implantation of its Vercise™ DBS System as part of the INTREPID clinical trial. INTREPID is a prospective, multi-center, double-blinded, randomized, controlled study to evaluate the safety and effectiveness of motor function and overall quality of life in patients with the Vercise DBS System for the treatment of Parkinson’s disease. According to the press release:
Not new, but recently came across while researching some information about related devices…
The NASA Tech Briefs of May 1999 described a device that telemeters pressure changes to detect intrauterine contractions. According to the brief:
A biotelemetric system for monitoring key physiological parameters of a fetus and its uterine environment is undergoing development. The main purpose of the monitoring is to detect preterm labor in order to enable timely treatment. At the present stage of development, the system monitors pressure changes and temperature. The pressure changes serve as direct indications of intrauterine contractions that could be associated with the onset of preterm labor. Future versions of the system are expected to monitor additional parameters, including pH and the heart rate of the fetus.
I have been honored with an invitation to present at the Fourth IEEE CASS Summer School on Wearable and Implantable Biomedical Circuits and Systems in Bogotá, Colombia (July 9 – 12, 2013).
I will be giving two 1 hour and 20 minute talks on “A Practical Perspective on Developing Novel Commercial Active Implantable Medical Devices”. Unlike other commercial devices, developing medical implantable devices takes place in a heavily regulated environment which requires decisive proof of the devices’ safety and efficacy. Costs, schedules, and clinical strategies must be planned accordingly to achieve a successful exit. This two-part lecture will focus on the practical technical and business-oriented aspects of planning and executing the development of implantable medical devices intended for a commercial application.
FDA has published a draft of the guidance document that it has developed to assist industry by identifying issues related to cybersecurity that manufacturers should consider in preparing premarket submissions for medical devices. This guidance document is intended to supplement FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and “Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software”
According to the guidance, “The need for effective cybersecurity to assure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information.”
Comments from the public are due to the FDA by September 12, 2013.
Click here for a pdf copy of the guidance document.
In June 2012 Neurotech s.a. (http://www.neurotech-int.eu), a Belgium based developer and manufacturer of neurostimulation devices, obtained the CE Mark for its ADNS-300 system for the treatment of refractory epilepsy. According to the press release:
“Advens therapy” uses the ADNS-300 stimulator as a therapeutic option for those patients who are refractory to anti-epileptic drugs and are not eligible for epilepsy (brain) surgery. The ADNS-300 is the world’s first rechargeable neurostimulator for vagus nerve stimulation. The device includes an innovative electrode and a promising “sensing” feature that may prove to be a significant technological breakthrough in the control of response to the therapy. Patients use a remote controller and charger to turn the system on/off and to recharge the neurostimulator. “Rechargeable systems may prove to be more cost-effective, especially if surgical operations to replace batteries are avoided over time. This helps patients to maintain a more independent life, with a lower risk of potential complications associated with battery replacement surgery.” ‘The role of Rechargeable Systems in Neuromodulation Paul Eldridge et al.’
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.
St. Jude Medical and privately-held Spinal Modulation, Inc., today announced that they have entered into a series of agreements under which St. Jude Medical made a $40 million equity investment in Spinal Modulation, a company that has developed an innovative neuromodulation therapy that provides a new pain management option for patients with chronic, intractable pain.
According to the announcement, “the agreement provides St. Jude Medical with an exclusive option to distribute the Axium™ Neurostimulator System, developed and manufactured by Spinal Modulation, in international markets where it is approved for sale. Additionally, St. Jude Medical will have the exclusive option to acquire the company for up to $300 million plus certain revenue-based milestones following U.S. commercialization.
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.