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

Category Archives: Sensors

FDA approves Endotronix’s Cordella PA Sensor

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

Endotronix announced that it received FDA’s PMA approval for its Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of NYHA class III heart failure patients. According to Endotronix, “The Cordella platform is the first and only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.”

According to the announcement:

“Cordella is a proactive HF management platform that delivers daily PA pressure and other vital data via an implantable sensor and user-friendly, non-invasive health tools, respectively, to a managing HF clinician for remote patient care. This information guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes. Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a markedly low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months.”

Senseonics receives FDA iCGM Designation for Eversense® CGM System

Posted on by Posted in Diabetes, Glucose Monitoring, Senseonics, Sensors
Eversense® Implantable Continuous Glucose Monitoring System

From: Lorenz, Carrie & Sandoval, Wendolyn & Mortellaro, Mark. (2018). Interference Assessment of Various Endogenous and Exogenous Substances on the Performance of the Eversense Long-Term Implantable Continuous Glucose Monitoring System. Diabetes Technology & Therapeutics. 20. 10.1089/dia.2018.0028.

Senseonics in Germantown, MD announced that its Eversense® Implantable Continuous Glucose Monitoring System has received the iCGM designation by the FDA.  iCGM status indicates that Senseonics’ Eversense iCGM product can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system.

According to the announcement:

“As the first fully implantable device in the category, Eversense has been authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future for devices of the same type.

…  The companies plan to advance partnership discussions with various pump manufacturers, with plans to offer people who choose to integrate their diabetes devices a new interoperable CGM option that is exceptionally well suited for AID systems. This is because Eversense addresses common limitations of AID systems outlined in the 2022 Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.”

The Eversense subcutaneously implantable glucose sensor has been validated for up to 180-day implant periods.  Unlike other  CGM systems that use
electrochemical- and enzymatic- (i.e., glucose oxidase and glucose dehydrogenase) based methods to measure glucose concentrations, the Eversense CGM sensor uses an abiotic (non–enzyme based), fluorescent glucose-indicating polymer to measure glucose.

The CARSS OpenNerve Device: An Open-Source Neuromodulation System for Autonomic Nerves

Posted on by Posted in CARSS, Med-Ally, Medipace Inc., Neural Stimulation, Sensors

Image Credit: CARSS

The University of Southern California, Medipace Inc., and Med-Ally LLC are the CARSS collaborative team part of NIH’s Human Open Research Neural Engineering Technologies (HORNET) initiative for open-architecture, open-source implantable neuromodulation system.  This team is developing the OpenNerve implantable neuromodulation platform, which consists of an IPG with an associated charging device. The OpenNerve IPG will perform current-based neuromodulation, measure impedance, monitor electronic biosignals, and interface with chemical and physical sensors.

All files relevant to the design and manufacture of the CARSS OpenNerve Platform are available on a Github repository. Details are posted on the project’s Wiki.

Image Credit: CARRS

Endotronix Submits PMA Application for the Cordella PA Sensor

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

Endotronix, announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the FDA.

According to the announcement:

“Cordella is an innovative HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home. Its user-friendly devices securely transmit daily health information to the managing clinician, supporting optimal dosing of guideline-directed medical therapy (GDMT) to reduce congestion and engaging patients with trended health data to enable healthy lifestyle choices.”

In April 2023 Endotronix completed the enrollment of its PROACTIVE-HF pivotal study.  Primary endpoint data from the trial is expected to support the PMA Application.

 

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

 

Vectorius Medical’s V-LAP Left Atrial Filling Pressure Sensor

Posted on by Posted in Heart Failure (CHF), Sensors, Vectorius Medical

Image Credit: Vectorius Medical

Vectorius Medical was founded in 2011 in the RadBioMed incubator in Tel-Aviv, Israel. It developed the V-LAP implantable device for the measurement of Left Atrial Filling Pressure (LAP).

The device is implanted in the left atrium, has no battery, and is able to communicate with an external interrogator from deep within the body using high-resolution waveform morphology. According to Vectorius Medical:

“Since the pressure of the heart’s left atrium is the earliest and most accurate real-time indication of heart failure exacerbation, the actionable feedback provided by the V-LAP will enable a significant improvement in ongoing management of heart failure patients. Once patients are implanted with the V-LAP, they will be able to measure left atrial pressure (LAP) daily at home via an easy, non-invasive method using a small, portable external unit.

…

Left atrial pressure has been scientifically established as the most specific physiological indication for heart failure exacerbation. Approximately 90% of patients admitted to the hospital for heart failure have pulmonary congestion related to elevated left atrial filling pressure (LAP). The increase of LAP is the earliest sign of impending heart failure exacerbation – long before clinical symptoms occur.”

The Vectorius system is intended to provide daily readings patient hemodynamic pressure to provide early, accurate physiological indication of cardiac decompensation. Physicians can access data through a Cloud-based system.

On February 4, 2019, Vectorius announced the initiation of the VECTOR-HF First-in-Human (FIH) clinical trial, and the successful first ‘in-human’ implantation of the V-LAP monitoring device. According to Vectorius Medical:

“Implantation of the device in this first “In-Human” trial was completed in just six minutes. It was fixated within the patient’s interatrial septum of the heart using a standard minimally-invasive percutaneous procedure under fluoroscopy and echocardiographic guidance, with the application of local anesthesia.”

Vectorius’ website is at: http://vectoriousmedtech.com

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.