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

Category Archives: Telemetry

Relief Cardiovascular’s IVC flow modulation for HF treatment

Posted on by Posted in Heart Failure (CHF), IVC flow modulation, IVC Monitoring, Relief Cardiovascular
Render of Relief Cardiovascular's Relief System for the treatment of heart failure congestion through modulating inferior vena cava flow and monitoring venous hemodynamics

Render of what Relief Cardiovascular’s RELIEF System may look like. Based on image presented by Professor Alex Rothman at CSI congress’ Focus D-HF. Note: this is not an official Relief Cardiovascular image.

Relief Cardiovascular is a private early-stage company founded in 2022 and focused on transcatheter implants for heart-failure congestion, especially volume-overload and diuretic-resistant disease. It is backed by cardiovascular-focused investors including Broadview Ventures, Advent Life Sciences, Good Growth Capital, and Heartwork Capital.

The company’s lead product is the RELIEF System, which it describes as a permanently implanted transcatheter valve-and-sensor system intended to improve fluid management in heart failure by modulating inferior vena cava flow and monitoring venous hemodynamics. Relief says the implant is placed in the IVC below the renal veins, where it can reduce venous pressure, increase renal perfusion, and collect daily pressure waveforms for clinician-directed therapy through a cloud-enabled interface. Continue reading→

Fire1’s Inferior Vena Caval Size Monitor

Posted on by Posted in FIRE1, Heart Failure (CHF), IVC Monitoring
Fire 1 Inferior Vena Caval Size Monitoring

Image Credit: Fire 1

FIRE1 is an Ireland-based company developing an implantable Inferior Vena Cava (IVC) size sensor for heart failure monitoring.   The FIRE1 System is a device designed to directly measure a patient’s volume status by measuring the IVC, which is the largest vein in the body where most fluid is stored.

The FIRE1 sensor is implanted at the abdominal level and works by measuring the size of the IVC to give a marker of the amount of fluid in the body. High levels can increase the risk of breathing difficulties and a build-up of fluid in the lungs which lead to an emergency hospital admission. The patient wears a belt reader around the abdomen for around a minute a day to take a reading from the sensor and the data is sent to the patient’s clinical team at the hospital. The system is designed to alert whenever the patient’s condition deteriorates.

In March 2024, FIRE1 announced that it has completed patient enrollment in the U.S. Early Feasibility Study (FUTURE-HF2) of its system. Results presented at CRF’s THT showed that all enrolled patients (n=8) met their safety and effectiveness endpoints.

Endotronix Reaches 100 Implants of the Cordella™ Pulmonary Artery Pressure Sensor

Posted on by Posted in Endotronix, Heart Failure (CHF), Sensors, Telemetry

Endotronix, a privately held company based in Illinois, recently announced that it had reached 100 implants of the Cordella™ Pulmonary Artery Pressure Sensor.  These sensors provide heart pressure readings to the Cordella™ Heart Failure System to empower clinicians to proactively adjust therapy and medications remotely without the need for office visits.

According to the announcement:

“The Cordella System enables scalable remote heart failure management and aims to increase guideline directed medical therapy (GDMT) adherence and provide early detection of worsening heart failure. The platform consists of a comprehensive patient management system that securely collects non-invasive daily health data, coupled with a seamlessly integrated, next-generation implantable PA pressure sensor. Together, they deliver the necessary information for clinicians to proactively titrate medications and improve patient care between office visits while supporting reimbursement for care delivery activities.”

The Cordella PA implantable sensor is still an investigational device.

Endotronix website: endotronix.com

 

iota Biosciences’ “Neural Dust”

Posted on by Posted in iota Biosciences, Neural Stimulation, Telemetry, Ultrasound

Image Credit: iota Biosciences

iota Biosciences was established in 2017, building up on the concept of “neural dust” technology invented at the University of California, Berkeley by iota co-founders and co-CEOs Jose Carmena, Ph.D. and Michel Maharbiz, Ph.D.

iota’s “neural dust” consists of a small implantable device (a few mm long) that is powered from an external ultrasound generator.  According to iota, their devices can record electrical information, stimulate nerves and communicate with other machines through ultrasound.  Iota claims that “neural dust” devices can modulate the information transmitted through nerves, enabling doctors to better treat conditions from arthritis to cardiovascular disease

In 2018 iota completed a $15 million series A funding round aimed at developing a sensing platform.  In September 2019, iota entered into a joint R&D agreement with Japanese Astellas Pharma to “design detailed specifications of implantable medical devices and conduct preclinical studies for several diseases with high unmet medical needs.”

Eventually, iota hopes to shrink the device to the size of grain of sand that can simultaneously sense neural activity and stimulate nerves to enable highly-targeted closed-loop therapies.

iota Biosciences’ website is at: https://iota.bio/

Destron Fearing Bio-Thermo Pet ID + Temperature Sensor Implantable Tag

Posted on by Posted in Destron Fearing, RFID, Telemetry

BioThermo implantable temperature sensor RFID tag

“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.

BioThermo implantable temperature sensor RFID tag

Continue reading→

Interesting Article in Medical Design Briefs: Designing an ASIC Chip to Control an Implantable Glucose Measurement Device

Posted on by Posted in Diabetes, Drug Delivery, Senseonics, Sensors, Sensors for Medicine and Science, Telemetry, Ultra-Low-Power ICs

Senseonics implantable glucose sensor www.implantable-device.com David Prutchi PhDSenseonics implantable glucose sensor www.implantable-device.com David Prutchi PhD

The current issue of Medical Design Briefs carries an interesting article titled “Designing an ASIC Chip to Control an Implantable Glucose Measurement Device” by Uwe Guenther of ZMDI (Dresden, Germany) and Andrew DeHennis of Senseonics (formerly known as “Sensors for Medicine and Science, Inc.” in Germantown, MD).

Zentrum Mikroelektronik Dresden AG (ZMDI), Dresden, Germany, partnered with Senseonics and developed a new microchip for use in Senseionics’ fluorescence-based implantable glucose sensor. According to the article, “ZMDI’s design specifications for this application-specific integrated circuit (ASIC), which is implemented as a system- on-a-chip (SoC) for control and analysis had to meet the following main requirements: LED driver, measurement and analysis of reflected light, data pre-processing, memory, wireless interface for data transfer, no battery due to extremely low power and low voltage requirements, medical certification, and special form factor.”

Click here for the online article.  Click here for a local pdf printout.

FDA Panel Majority Votes Against Effectiveness of CardioMEMS CHAMPION HF Monitoring Device

Posted on by Posted in CardioMEMS, Heart Failure (CHF), St. Jude Medical, Telemetry

CardioMEMS miniature implantable sensor for heart failure and aneurism management

Although the FDA advisory panel found CardioMEMS’ CHAMPION HF Pressure Measurement System to be safe, on October 9, 2013, the majority of panel members decided that the implantable sensor monitor to help guide treatment in patients with congestive heart failure is not effective.

According to Forbes, one panel member said it was difficult to connect the dots between use of the monitor and decreased hospitalization and lack of data on use in women.

This is not the first time that CardioMEMS attempts to receive PMA approval.  In 2011 FDA rejected the Champion implantable monitoring system for heart failure for premarket approval, in part due to questions about the validity of presented data. Last year, CardioMEMS received an FDA Warning Letter.

Implantable Blood Analyzer Chip Developed at École Polytechnique Fédérale de Lausanne

Posted on by Posted in Cancer, Diabetes, Telemetry
Implantable blood analyzer chip

Image Credit: EPFL. This implant measures about 14mm and comprises five sensors, a coil for wireless power as well a miniaturized electronics for radio communication

From Wired:

Written by Liat Clark

Edited by Nate Lanxon

“A multidisciplinary Swiss team has developed a tiny, implantable device that instantly analyses the blood before wirelessly sending the data to a doctor.

The device can be used for monitoring general health, but the team also sees immediate applications in monitoring the efficacy of treatments such as chemotherapy in order to tailor drug delivery to a patient’s unique needs.

Continue reading→

Biotronik Launches Implantable BioMonitor for Monitoring Arrhythmias

Posted on by Posted in Atrial Flutter/Fib, Biotronik, Dementia, ECG Monitoring, Tachycardia, Telemetry

Biotronik BioMonitor to diagnose arrhythmias. David Prutchi PhD www.implantable-device.comBiotronik announced the European market release of BioMonitor®, an implantable cardiac device designed for the highly accurate and reliable monitoring and management of patients with atrial fibrillation (AF) or unexplained syncope.

According to Biotronik’s press release:

“BioMonitor® is a subcutaneous implantable leadless cardiac monitor for the long-term continuous remote monitoring of patients with arrhythmias such as AF, bradycardia, sudden rate drop, asystole and tachycardia.

As sensitivity and specificity are essential in the detection of arrhythmias such as AF, BIOTRONIK has developed ClearSense Technology with a unique three-vector signal detection that produces highly precise and reliable arrhythmia monitoring.

Continue reading→

Remon Medical’s Implantable Pulmonary Pressure Sensor (1997-2007)

Posted on by Posted in Boston Scientific, Heart Failure (CHF), History, Remon Medical (1997-2007), Telemetry

Remon Medical (now Boston Scientific) implantable pulmonary artery pressure sensor

Remon Medical Technologies, Ltd. was founded in 1997 in Caesarea, Israel to develop implantable, wireless pressure sensors.

Remon developed an implantable hemodynamic monitor, which allowed on-demand, non-invasive, leadless self-monitoring of pulmonary artery pressure by the patient at home. ImPressure devices were placed in the pulmonary artery, and transmitted pressure readings to a hand-held monitor.  It was hoped that the system would provide early warning of the need for treatment, avoiding hospitalization and deterioration in the patient’s condition. Continue reading→

SMSI® Implantable Glucose Sensor

Posted on by Posted in Diabetes, Sensors for Medicine and Science, Telemetry

SMSI implantable glucose sensor Sensors for Medicine and Science, Inc. (SMSI)  of Germantown, MD was founded in 1997 to develop chemical sensing technologies based on fluorescence sensing.

SMSI® is now developing an implantable glucose sensor that is designed to automatically measure interstitial glucose every few minutes. The sensor implant communicates wirelessly with a small external reader, allowing it to track the rate of change of glucose levels and warn the user of impending hypo- or hyperglycemia. According to SMSI, the target operational life of the sensor implant will be 6-12 months, after which it would be replaced. Continue reading→

Medtronic’s Chronicle Implantable Hemodynamic Monitor for Heart Failure Monitoring

Posted on by Posted in ECG Monitoring, Heart Failure (CHF), History, Medtronic, Telemetry
Medtronics Chronicle Implantable Hemodynamics Monitor
Image Credit: Medtronic

The Medtronic Chronicle implantable hemodynamic monitor used a specialized RV lead/sensor.  The device was able to monitor and telemeter:

  • Systolic and diastolic pressure
  • Estimated pulmonary artery diastolic pressure
  • RV dp/dt (positive & negative)
  • Heart rate & activity
  • Core body temperature
  • Continuous remote monitoring
  • Continue reading→

CardioMEMS Miniature Implantable Wireless Sensors

Posted on by Posted in Aneurysm, CardioMEMS, Heart Failure (CHF), Telemetry

CardioMEMS miniature implantable sensor for heart failure and aneurism management

CardioMEMS was founded by Dr. Jay S. Yadav and Dr. Mark G. Allen in Atlanta, GA in 2000 to develop implantable micro-electromechanical sensors to improve the management of severe chronic cardiovascular diseases such as heart failure and aneurysms.

The miniature wireless sensors can be delivered through a catheter.  Once in place, they transmit cardiac output, blood pressure and heart rate data that are critical to the management of patients. Due to their small size, durability, and lack of wires and batteries, CardioMEMS’ sensors are designed to be permanently implanted into the cardiovascular system. An external reader is used to interrogate the sensors. Continue reading→