AIMDs classified according to general type of therapy
Image Credit: Abbott
Abbott released a very nice video on the (St Jude Medical) CONFIRM Rx Implantable Loop Recorder (ILR):
An interesting interview with Avi Fischer, M.D., divisional vice president and medical director of Abbott’s cardiac rhythm management business about the impact of the CONFIRM Rx Implantable Cardiac Monitor was published today by Medgadget.
Medtronic announced both the U.S. launch of Deep Brain Stimulation (DBS) for medically-refractory epilepsy and the first commercially implanted patient at Emory University in Atlanta, GA. According to Medtronic’s announcement:
DBS therapy for epilepsy delivers controlled electrical pulses to a target in the brain called the anterior nucleus of the thalamus (ANT), which is part of a network involved in seizures. Recently, the U.S. Food and Drug Administration (FDA) granted pre-market approval for Medtronic DBS Therapy for Epilepsy as adjunctive treatment for reducing the frequency of partial-onset seizures in individuals 18 years of age or older who are refractory, or drug-resistant, to three or more antiepileptic medications. The approval was based on results from the SANTE® (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) trial, wherein patients had a median seizure frequency reduction of 75 percent at seven years post-implant.
In addition to medically refractory epilepsy, DBS therapy is currently approved in the U.S. and Europe, for the treatment of the disabling symptoms of essential tremor and recent and longer-standing Parkinson’s disease. Under Humanitarian Device Exemption (HDE) approvals in the United States, the therapy can also be used to treat chronic intractable primary dystonia and severe, treatment-resistant obsessive-compulsive disorder.
Walking through MD&M is always fun because component and assembly companies often display implantable devices that never made it to market or technologies that they are incorporating into brand new devices that have not yet reached prime time.
AJ Medical’s CardioAlarm is a sample of an implantable device that didn’t quite made it. It was meant to automatically detect cardiac arrest and use a wirelessly-connected pager-like device to alert bystanders and call 911.
As many other alert implantable medical devices, CardioAlarm didn’t make it to market. The latest victim being Angel Medical needing to seek Chapter 11 bankruptcy protection soon after achieving FDA approval for its Guardian Implantable Heart Attack Monitor, although hopefully this is just a financial restructuring exercise to gear up for full commercialization of the device.
VisCardia Inc. is a privately held medical device developer based in Portland, Oregon. Their VisONE® implantable system delivers VisCardia’s proprietary “Asymptomatic Diaphragmatic Stimulation” (ADS) therapy to improve cardiac function. The idea is that by electrically stimulating the diaphragm in an asymptomatic manner, transient intrathoracic pressures gated to cardiac activity are applied against the cardiac walls, improving both cardiac filling and output.
VisCardia demonstrated in preclinical and early feasibility studies that ADS improves acute hemodynamic parameters and chronic left ventricular ejection fraction.
VisCardia announced the first human implant of the VisONE® IPG in the Ukraine in August 2018. They are now conducting a 12-month pilot study on moderate heart failure patients with reduced ejection fraction.
A curious device spotted at the 2019 MD&M West was the C-MIC from Berlin Heals GmbH – a private company based in Berlin, Germany.
Berlin Heals is developing an implantable electroceutical device (C-MIC) intended to readjust the disturbed myocardial electrical gradient that, according to Berlin Heals, occurs in heart failure patients. According to the company, preclinical trials have confirmed that failing hearts with an extremely remodeled myocardium show reverse remodeling with normalized heart function after a short treatment period using a DC electrical gradient applied to the myocardium.
The latest publication on the company’s technology is “Bioelectrical signals improve cardiac function and modify gene expression of extracellular matrix components”, ESC Heart Failure 2017; 4: 291–300. It is available online at https://onlinelibrary.wiley.com/doi/epdf/10.1002/ehf2.12169 An animation of the proposed therapy is available at: http://berlinheals.de/what-we-do/
Berlin Heals website: http://berlinheals.de/
Last week we performed the first human implant of the new OPTIMIZER Smart IPG intended for the treatment of Chronic Heart failure in patients that are symptomatic despite appropriate medical treatment.
The first implant of the Optimizer Smart was performed by Dr. Markus Reinartz (left in picture above) at the Herz-Jesu Hospital in Dernbach, Germany. The device’s new, two-lead configuration enables an easier and faster implantation procedure.
Notes:
• The OPTIMIZER Smart System is not currently available in the US. The OPTIMIZER IVs System is currently an Investigational Device in the US.
• I am the Executive VP of Product Development at Impulse Dynamics. However, the statements and opinions expressed in this blog are my own and do not necessarily represent those of my employer.
• This blog post is not intended to act as an advertisement for Impulse Dynamics or its products.
“Bio-Thermo” implantable tags combining animal ID and temperature measurement are manufactured by Destron Fearing (www.destronfearing.com). The Bio-Thermo tags were originally produced by a company named “Digital Angel” in Delray Beach, FL. The Bio-Thermo tag is covered under a 2006 US Patent No. 7,015,826 “Method and Apparatus for Sensing and Transmitting a Body Characteristic of a Host.”
Digital Angel merged with Veriteq in 2013. VeriTeq owned the IP to Sicel’s implantable dosimeter products. VeriTeq is no longer in the business of selling human or animal ID tags, probably as a result of the outcry by the ignorant populace claiming that implantable RFID chips are “the Mark of the Beast”. Instead, they have reinvented their tags approved for human use as UDI (unique device identifiers) for medical devices. Their website states that they plan to relaunch the implantable radiation dosimeters.
The Bio-Thermo tag is a small (12mm length) “microchip” which offers a unique numerical identity, as well as instantaneous temperature recording accurate to 0.1 degree F or C using its Bio-Thermo™ sensor. Although Bio-Thermo™ is implanted subcutaneously in the shoulder region, the correlation of the temperature with the traditional rectal reading is excellent. Multiple temperature readings can be taken with no stress to the patient, so it is ideal for monitoring temperature after surgery where minimal disturbance is desired. Non-invasive measurements also allow easy monitoring of animal health, wellness, and breeding cycle.
St. Jude Medical today announced the approval of its Protégé™ IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates. According to the press release:
Chronic pain sufferers implanted with this new device can access innovative therapies, stimulation modes, diagnostics or other features once approved through future software upgrades — without the need to surgically replace their medical device.
Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA. There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation:
I can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it is documented by Kirk Jeffrey in “Machines in our Hearts”:
“In 1968, Robert Fischell, of the Applied Physics LOaboratory at Johns Hopkins University, and cardiologist Kenneth B. Lewis had begun a collaboration that led in 1973 to a new kind of Ni-Cad battery able to function more effectively at body temperature and hermetically sealable. Alfred E. Mann, a California entrepreneur with background in the aerospace industry, had provided some financial support to the Hopkins group. Eventually Mann founded a small company to develop a pacemaker for the rechargeable battery; this was the origin of Pacesetter Systems. The rechargeable pacemaker reached the market in the summer of 1973, just as CPI introduced its lithium pacer.”
On January 20, 2014, Mass Device reported that Greatbatch filed a CE Mark application for its spinal cord stimulation system with German notified body TÜV SÜD America. The spinal cord stimulation system comes from Greatbatch’s subsidiary, QiG Group. The company also applied for pre-market approval last month.
On Jan 29, 2014, Second Sight Medical announced that it had performed the first commercial implants of the Argus II visual prosthetic at the University of Michigan’s Kellogg Eye Center. Second Sight plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete about three months of rehabilitation and training. The retinal implant, approved by the FDA in 2013, is designed to enhance vision in patients who have been progressively blinded by the condition retinitis pigmentosa.
![IMAGE_Nanostim_Product_Shot[1]](https://www.implantable-device.com/wp-content/uploads/2013/10/IMAGE_Nanostim_Product_Shot1.jpg)
St. Jude today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for FDA approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy. The LEADLESS II pivotal trial is a prospective, non-randomized, multi-center, international clinical research trial designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in patients indicated for the device. It is being conducted under an Investigational Device Exemption (IDE) from the FDA, and will enroll approximately 670 patients at 50 centers in the U.S., Canada and Europe.
According to the press release:
The Nanostim leadless pacemaker is designed to be placed directly in the heart without the visible surgical pocket, scar and insulated wires (called leads) required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device offers physicians the same pacing therapy through a less-invasive approach as compared to traditional pacemaker procedures that require more extensive surgery. The device is designed to be fully retrievable, so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.
Medtronic’s new Reveal LINQ Insertable Cardiac Monitor is a tiny implantable device that weighs less than three grams and is far less invasive than any previous loop recorder. The figure above shows its diminutive size compared to the Reveal XT device – it is a full 87% smaller!
The Reveal LINQ is a leadless device that is implanted in the region of the thorax by way of a <1cm incision. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias.
Reveal LINQ stores a total of 57 minutes of ECG, including 27 minutes of automatically-detected episodes and up to 30 minutes of patient-activated recordings with 6.5–14 min. buffers.
The device connects wirelessly with Medtronic’s MyCareLink™ Patient Monitor, making the Reveal LINQ ICM the only ICM to collect and trend data continuously and wirelessly.
According to the press release:
At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned if needed. The miniature device does not require the use of wires, known as “leads,” to connect to the heart. Attached to the heart via small tines, the pacemaker delivers electrical impulses that pace the heart through an electrode at the end of the device.
Sorin announced the CE Mark approval and first implant of its KORA 100 pacing system.
According to the press release:
KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging (MRI) safely.[1] Pacemaker patients are typically older than 65 years. This patient population is prone to other medical conditions such as arthritis, cancer or stroke that may require MRI examinations for optimal diagnosis and management.
The KORA 100 pacing system has been designed with both patients and physicians in mind. Device settings which allow safe operation during an MRI examination are automatically enabled when KORA 100 pacemakers detect the scanner’s magnetic field. Similarly the devices sense when a patient leaves the MRI field, and return to normal operation within five minutes. The Automatic MRI Mode feature, which is patented and available exclusively on Sorin Group pacemakers, limits the amount of time that KORA 100 pacemakers operate in MRI mode.