A blog about what is new (and old) in the world of active implantable medical devices 

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Neuromodulation Startup NeuroTronik Raises $13.1M for Development of System for Treating Acute Heart Failure Syndrome

NeuroTronik, a recent spin-off from Synecor, a Chapel Hill business accelerator, announced that it has raised $13.1M for the development of a neuromodulation system intended for the treatment of acute heart failure syndrome. Douglas Reed, a partner in the VC group backing NeuroTronik said that the device aims to shorten hospital stays and reduce the need of

 
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EnteroMedics Submits PMA of the Maestro VBLOC System for Treatment of Obesity

EnteroMedics  reported that it has submitted its pre-market approval application for FDA review of its Maestro Rechargeable System’s VBLOC vagal blocking therapy as a treatment for obesity This is an important step for an implantable device company that faced very tough times in 2009 after its US clinical trial failed to meet a critical effectiveness

 
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NeuroPace Raises $18M of Planned $50M

NeuroPace is a privately-held company in Mountain View, CA. Their RNS® implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy. Unlike Cyberonics’ VNS IPGs, the RNS neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to

 
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Proposed Microgravity Testing of AIMDs

  With the popularization of space tourism, I would hereby like to propose the addition of a clause to 45502-1 to be titled “Protection of the active implantable medical device from microgravity conditions“.  I propose the following language: The implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be designed and constructed so that no irreversible

 
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TYRX receives FDA Approval for Fully Resorbable AIGISRx R Antibacterial IPG Envelope

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.

 
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Aleva Neurotherapeutic’s Ultra-Flexible Electrode Arrays for DBS

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

 
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Mainstay Medical’s Reactiv8 to Treat LBP Caused by Arthrogenic Muscle Inhibition

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

 
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Neuros Medical’s Altius™ High Frequency Electrical Nerve Block™ Pain Therapy

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 Issues Urgent Class-I Recall Notifications for the SynchroMed® Implantable Infusion System

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

 
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St Jude Receives CE Mark for Quadra Assura MP™ Multipoint CRT-D

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)

 
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Sorin Launches Reply 200 Pacemakers with Sleep Apnea Monitoring

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

 
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Boston Scientific Begins Patient Enrollment in U.S. Clinical Trial of Vercise™ DBS for Parkinson’s Disease, Presents EU Data

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. 

 
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Implantabe Preterm Labor Monitor

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

 
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IEEE Summer School on Implantable Devices – Bogotá, Colombia (July 9 – 12, 2013)

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”. 

 
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FDA Publishes Draft Guidance on Medical Device Cybersecurity

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

 
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