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

Cyberonics’ Vagus Nerve Stimulators

Posted on by Posted in Cyberonics, Epilepsy, Vagus Nerve Stimulation

Image credit: Cyberonics

Cyberonics was founded in Houston, TX in 1987 to develop an implantable device for the treatment of epilepsy.  In July 1997, The FDA approved the VNS Therapy System (formerly known as the NCP® NeuroCybernetic Prosthesis System) as an adjunctive epilepsy treatment for adults and children over 12 years of age with partial onset seizures refractory to drugs.

Cyberonics currently markets the VNS Pulse and VNS Demipulse IPGs, which offer approximately 6 years of longevity at nominal stimulation settings (2 mA, 20 Hz, 500 msec, 10% duty cycle into a 4 kOhm load).

Continue reading→

Respicardia’s remedē Implantable Device for the Treatment of Central Sleep Apnea

Posted on by Posted in Central Sleep Apnea, Heart Failure (CHF), Respicardia, Sleep Apnea

Image Credit: Respicardia

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 medical device that is being investigated in a clinical research study for the treatment of Central Sleep Apnea in patients with Heart Failure.  It consists of three implantable components:

  • remedē Pulse Generator comprised of electronic circuitry components and a battery, which are hermetically sealed in a titanium case
  • remedē Stimulation Lead that is implanted in a vein close to one of the phrenic nerves
  • a sensing lead to detect respiration Continue reading→

ImThera Medical’s Aura6000 Implantable System for the Treatment of Sleep Apnea

Posted on by Posted in ImThera Medical, Obstructive Sleep Apnea, Rechargeable Batteries, Sleep Apnea
ImThera Aura 6000 implantable device for the treatment of obstructive sleep apnea

Image Credit: Imthera

The aura6000 is based on ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy™ delivering neurostimulation to the tongue during sleep. The system is comprised of a surgically‐placed multi‐contact electrode specifically designed for the Hypoglossal nerve, and a lead that connects the electrode to a programmable implantable pulse generator (IPG) that is placed in the anterior chest wall. The device delivers muscle tone to key tongue muscles, preventing the tongue from collapsing into the upper airway, thus permitting normal breathing during sleep. Continue reading→

Apnex Medical’s Implantable Device for Treatment of Sleep Apnea

Posted on by Posted in Apnex Medical, Obstructive Sleep Apnea, Sleep Apnea

Image Credit: Apnex Medical

MedicalApnex Medical, Inc. is located in St. Paul, MN. It was founded in 2006 and has developed the Hypoglossal Nerve Stimulation System (HGNS® System) for the treatment of obstructive sleep apnea (OSA). The HGNS System has been evaluated in feasibility studies and is now being assessed in an Investigational Device Exemption (IDE) Study (Apnex®Clinical Study).

The Apnex HGNS System is an implantable therapy that is intended to work by activating the muscles in the upper airway to ensure that the airway remains open during sleep. During sleep, the system detects the patient’s breathing and delivers mild stimulation to the hypoglossal nerve, the nerve that controls the muscles of the tongue, to keep the airway open. The stimulation is timed to a patient’s own breathing pattern. The HGNS System is programmed to work only when the patient is asleep, or it can be turned on and off as needed through a handheld controller. Continue reading→

Inspire Medical’s IPG for the Treatment of Sleep Apnea

Posted on by Posted in Inspire Medical, Sleep Apnea

Image credit: Inspire Medical

Inspire Medical Systems, based in Minneapolis, Minnesota, develops implantable neurostimulation systems to treat Obstructive Sleep Apnea (OSA).  Inspire Medical Systems was formed when the Inspire intellectual property and technology was licensed and spun out from Medtronic in 2007.

Inspire therapy is designed to deliver physiologically-timed, mild stimulation to the hypoglossal nerve on each breathing cycle to prevent airway obstruction during sleep.

Continue reading→

Angel Medical’s Guardian Implantable Heart Attack Monitor

Posted on by Posted in Acute Coronary Syndrome, Angel Medical, Heart Failure (CHF)

Photo Credit: PRNewsFoto/Angel Medical Systems

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 is designed to alert patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings.  The AngelMed Guardian system is intended to address the challenge of patients not recognizing nor responding quickly to heart attacks. Continue reading→

Brainsgate’s Spheno-Palatine Ganglion Stimulator

Posted on by Posted in Brainsgate, Dementia, Ischemic Stroke, Wireless Power Transmission, Yossi Gross (Rainbow Medical)

Image Credit: Brainsgate Website

Brainsgate‘s implantable pulse generator is designed to stimulate the Spheno-Palatine Ganglion.   It is activated by an external transcutaneous energy transmitter.  Brainsgate is evaluating the system’s capability to  augment cerebral blood flow as a treatment of ischemic stroke or dementia. Continue reading→

AIMD Companies Founded by Yossi Gross

Posted on by Posted in BetaStim, BioControl, Brainsgate, CerebralRx, Diabetes, Enopace Biomedical, Epilepsy, Heart Failure (CHF), Hypertension, Obesity, Vagus Nerve Stimulation, Yossi Gross (Rainbow Medical)

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 drug-delivery technology
  • BioControl Medical, developing neurostimulation devices
  • Enopace Biomedical, developing implantable devices for heart failure treatment through stimulation of the aorta
  • CerebralRx, a spin-off from Biocontrol developing vagus nerve stimulators for the treatment of epilepsy

 

AIMD Companies Founded by Dr. Shlomo Ben-Haim

Posted on by Posted in Diabetes, Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics, MetaCure, My Portfolio, Obesity

Dr. Shlomo Ben-Haim has held faculty appointments as a Professor of Medicine, Physiology and Biophysics, at both Harvard University and the Technion – Israel Institute of Technology. His formal education is in the fields of nuclear physics, mathematics, biomedical engineering, philosophy, and medicine. Dr. Ben-Haim has published his research in over 100 scientific papers, in peer-reviewed journals. He holds over 180 patents and patent applications.

Currently, two companies led by Dr. Ben-Haim are focusing on active implantable medical devices:

  • Impulse Dynamics, which developed the OPTIMIZER System for the treatment of heart failure
  • MetaCure, which developed the TANTALUS System for the treatment of metabolic syndrome

AIMD Companies Founded by Mir A. Imran (InCube)

Posted on by Posted in Atrial Flutter/Fib, Corhythm, Intrapace, Mir A Imran (InCube), Neurolink, Obesity, Pain, Spinal Modulation

Mir A. Imran (born 1956, Hyderabad, India), is an Indian entrepreneur and venture capitalist. Imran has formed 19 companies since the early 80s and holds over 140 patents.  He is the founder and Chairman of InCube Laboratories, Inc., a research laboratory and business incubator for medical and technology companies

Currently, four InCube companies are focusing on active implantable medical devices:

  • Intrapace, which is developing an implantable device to treat obesity
  • Spinal Modulation, which is developing a novel therapy for the management of chronic pain with an implantable microstimulator
  • Neurolink, which is developing a novel therapy for epilepsy
  • Corhythm, which is focused on the treatment of AFIB

Spinal Modulation Neuromodulation System

Posted on by Posted in Mir A Imran (InCube), Pain, Spinal Modulation
Spinal Modulation Neurostimulator

Photo credits: Obtained from Spinal Modulation's site

Spinal Modulation is a company based in Menlo Park, CA.  It has developed a neurostimulator for chronic intractable pain management.

According to the company, the Spinal Modulation System utilizes low-level electrical signals to modulate neural structures of primary sensory neurons located within the dorsal root ganglion (DRG). These cell bodies have been implicated in the development and maintenance of chronic pain conditions. Continue reading→

MTC’s Piezos Used for Wireless Power Transmission in EBR’s Wireless Pacemaker

Posted on by Posted in Bradycardia, EBR Systems, Engineering & OEM Services, Heart Failure (CHF), Wireless Power Transmission

Morgan Technical Ceramics (MTC) announced that its Bedford, Ohio site manufactures the piezoelectric ceramic materials used in EBR Systems, Inc.’s innovative new WiCS® Wireless Cardiac Stimulation System. The PZT (lead zirconate titanate) material made by MTC is critical to the efficiency of the WiCS system, which is powered by a battery with a 10-year lifespan.

The WiCS technology, which recently began clinical trials, is the first truly wireless pacing device. It was developed to eliminate cardiac pacing leads, historically a major source of complications and reliability issues. Continue reading→

ST Microelectronics Developing Implantable SOCs

Posted on by Posted in Engineering & OEM Services, Ultra-Low-Power ICs

Medical Product Manufacturing News announced that ST Microelectronics is developing ultra-low-power Systems On Chip (SOCs) suitable for implantable medical devices.  ST Microelectronics’ 65nm features a Vt of only 0.6V that can be used very near threshold.  The REISC processor consumes barely 10.8pJ/cycle at 0.6V.  This type of technology will certainly enable many new implantable devices that must operate at extremely low powers and squeeze every bit of juice out of their batteries or energy-harvesting means.  Click here for link to article.

NEXUS Pacemaker with Hemodynamics Sensing and Patient Alert

Posted on by Posted in Bradycardia, Intermedics (1974-1999), My Portfolio

(c) 2011 David Prutchi

Intermedics’ next-generation pacing platform would have been full of neat features such as: hemodynamic sensing (impedance-based hemodynamic sensor), autocapture (capture verification), autothreshold (self-tuning based on automatic strength-duration curve generation), high-quality digital telemetry, large-volume memory for electrogram storage, non-volatile memory for self-recovery and patient information, advanced noise detection, etc. My favorite feature though was “Patient Alert”. That saddle-shaped electrode in the picture was used to stimulate the patient’s pectoral muscles whenever the pacemaker wanted to alert the patient of a problem (e.g. low battery, fractured lead, etc.). The project was canceled when Guidant (now Boston Scientific) purchased Intermedics in 1998.