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

Category Archives: Heart Failure (CHF)

Implantable devices for the treatment of Congestive Heart Failure (CHF)

Impulse Dynamics receives full-body MRI-conditional approval for OPTIMIZER Smart Mini System

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, MRI-safe, My Portfolio

OPTIMIZER Smart Mini whole-body MRI

Impulse Dynamics, the company for which I am the CTO, announced that FDA has approved full-body MRI-conditional labeling for the OPTIMIZER Smart Mini IPG.  According to the announcement:

“The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.”

Impulse Dynamics Announced First Implant for Integra CCM-D™ Clinical Trial in May 2023

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Pacing, Cardiac Stimulation (other), Cardioversion/Defibrillation, David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics, My Portfolio, Tachycardia
Impulse Dynamics OPTIMIZER Integra CCM-D IPG

Image credit: Impulse Dynamics

Impulse Dynamics, the company where I am the CTO and Executive VP of Product Development, announced on May 18, 2023 the completion of the first implantation for the INTEGRA-D clinical trial, designed to evaluate the safety and efficacy of two proven cardiac therapies combined — CCM® and an implantable cardioverter defibrillator (ICD) — in a single device (CCM-D). The Optimizer® IntegraTM CCM-D System delivers CCM therapy to improve quality of life and reduce heart failure symptoms, and ICD therapy to treat life-threatening arrhythmias that may cause sudden cardiac death. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.

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Impulse Dynamics Launched Optimizer Smart Mini in April 2022

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Stimulation (other), David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics, My Portfolio
Impulse Dynamics OPTIMIZER Smart Mini IPG by Impulse Dynamics

Image Credit: Impulse Dynamics

Back on April 29, 2022, Impulse Dynamics, the company where I am the CTO and Executive VP of Product Development, announced both FDA and CE Mark approval and the official commercial launch of the Optimizer® Smart Mini System.

According to the press release:

The Optimizer Smart Mini delivers CCM therapy — Impulse Dynamics’ proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.

The OPTIMIZER Smart Mini offers increased battery longevity of 20 years (compared to 15 years in the previous generation), advanced HF diagnostic monitoring capabilities (e.g., heart rate, heart rate variability, patient posture and position), and remote patient monitoring features that will be activated in the near future.

Impulse Dynamics Implants First Patient in AIM HIGHer Trial to Treat HF with High EF

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, My Portfolio

On March 14, 2022, Impulse Dynamics (of which I am the CTO and Executive VP) conducted the first implant of a patient in its AIM HIGHer trial.  The goal of the blinded study is to evaluate the performance of CCM Therapy  to treat heart failure in a population with high ejection fraction (LVEF between 40% and 60%, inclusive).

According to the press release:

“Patients can have HF with severely reduced, moderately reduced, or even preserved ejection fraction (e.g., EF close to the normal range of 60% or above.) Those patients with severely reduced or moderately reduced EF have therapeutic options, including many classes of pharmaceuticals and device therapies such as CCM. However, HF patients with higher EF (e.g., above 40%) have had few therapeutic options thus far to alleviate their symptoms and treat their disease. The purpose of AIM HIGHer is to assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients.

…

The Optimizer delivers cardiac contractility modulation therapy — a proprietary technology of Impulse Dynamics — to the heart. Impulse Dynamics has designed CCM therapy to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. This breakthrough device has demonstrated its capability of enhancing the quality of life for HF patients no longer responding adequately to medication meant to manage their symptoms.”

AIM HIGHer is the largest randomized sham-controlled therapeutic cardiac device trial to ever be conducted.

Heart Failure Left-Ventricle Wireless Pacing Company EBR System Raises AU$110M in the Australian Securities Exchange

Posted on by Posted in AIMD Business, Cardiac Pacing, EBR Systems, Heart Failure (CHF), Ultrasound

On November 24, 2021, EBR Systems went public in the Australian stock exchange.  According to the press release, the IPO raised AU$110M (around $78.5M).  EBR pland to use these funds to complete its pivotal study, targeting FDA submission for approval in 2023 followed by rapid U.S. commercial launch.

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Boston Scientific Recalls 48,000 Ingenio Pacemakers

Posted on by Posted in Boston Scientific, Bradycardia, Cardiac Pacing, Heart Failure (CHF)

Boston Scientific has recalled approximately 48,000 Ingenio pacemakers and cardiac resynchronization devices distributed between November 2011 and August 2020.  The potentially defective devices, which were manufactured only through December 2018, are no longer available for implant. The recall was initiated on June 3, 2021, and now FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

There have been 65 reported incidents, including three injuries which required patients to receive temporary external pacing. There have been no reports of death.

The issue is that after several years of use, the batteries  reach a high level of internal impedance. At that point, a sudden decrease in battery voltage may occur during telemetry, incorrectly triggering a system reset. If the system resets three times within 48 hours, it’s sent into safety mode.  However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device goes into safety mode, the device cannot be reprogrammed and must be replaced.

According to FDA, the use of affected product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate with serious or life threatening injury (for example, need of temporary pacing where a healthcare provider delivers controlled electric pulses to pace a heart), worsening of heart failure and death.

Abbott’s St Jude Medical to Pay $27 Million to Settle DOJ Claims they Knowingly Sold Defective ICDs

Posted on by Posted in Abbott, Cardioversion/Defibrillation, Heart Failure (CHF), St. Jude Medical, Tachycardia

In October 2016, St. Jude Medical (now Abbott) issued an advisory on a family of ICD and CRT-D devices that may develop Lithium deposits within the battery leading to a short circuit and result in premature and potentially rapid battery depletion.  However, according to the DOJ, St. Jude was already aware of the issue by 2013.   In 2014 St Jude asked the FDA to approve an update to the devices to mitigate the battery issue. In its request, St. Jude claimed that the issue had not caused any serious injuries or deaths, but the DOJ claimed that the company had been informed of two injuries and one death caused by the issue.

The lawsuit covers the period between November 2014 and October 2016, during which the DOJ claims St. Jude was fully aware of the device’s issues but continued selling thousands of devices.  By August 2016, St. Jude reported to FDA two more deaths linked to this issue, and over 700 cases of premature battery depletion.

The federal case was brought under the False Claims Act based on the allegation that by continuing to sell the potentially harmful products to healthcare facilities and implanted in patients enrolled in Medicare and Medicaid, St. Jude played a role in securing government payments for devices that they knew were defective. It was announced on July 8, 2021 that St. Jude Medical agreed to pay $27 million to settle this case.

 

CVRx Files Intention to IPO with SEC

Posted on by Posted in AIMD Business, Baroreceptor Stimulation, CVRx, Heart Failure (CHF)

Image Credit: CVRx

Back in August of 2019, Minneapolis-based CVRx received a no-panel FDA approval for its BAROSTIM NEO™ device to treat Heart Failure.  CVRx has now filed documents with the SEC with plans to offer 6.25 million shares of common stock priced between $15 and $17 per share, expecting to yield approximately $91.5 million in the offering.

The BAROSTIM NEO™ implantable pulse generator is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck, targeting its baroreceptors.  The proposed mechanism of action is that the activation of baroreceptors cause the brain to relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.

CVRx’s system  is indicated for the improvement of symptoms in patients with advanced heart failure (EF≤35%) who are not suited for treatment with other heart failure devices.

CVRx website:  www.cvrx.com

UPDATE: June 30, 2021, 2:49 pm

Yesterday CVRx upsized its IPO of 7M shares of its common stock at a public offering price of $18 per share.  Trading started today and share price was $27 mid-afternoon.

UPDATE: July 9, 2021, 2:09 pm

A week after IPO CVRx’s stock has lost all of its initial gains.  It is now trading around the original offering price of $18.

 

 

Update December 13, 2021

And CVRx stock keeps on tanking…

Medtronic Stops Sale of HeartWare HVAD™ System After Multiple Class-I Recalls

Posted on by Posted in Circulatory Support, Heart Failure (CHF), Medtronic

Medtronic announced that it will stop the distribution and sale of HeartWare’s HVAD™ System.

According to the announcement:

“Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.

In addition, Medtronic previously issued an Urgent Medical Device Communication informing physicians that the HVAD pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death.”

The device has been the subject of multiple Class I recalls because of reports of 91 injuries and 15 deaths. FDA advised healthcare providers to stop new implants of the HeartWare system, stating that Medtronic has “received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was necessary.”

FDA has advised providers to use Abbott’s HeartMate 3 Left Ventricular Assist System as an alternative.

Bivacor Raises $22M to Start Human Trials of its Total Artificial Heart

Posted on by Posted in AIMD Business, Bivacor, Circulatory Support, Heart Failure (CHF)

Image Credit: Bivacor

Houston-based Bivacor, which was founded in 2008, has raised a total of $22M through a $19M series B funding round (co-led by Cormorant Asset Management and OneVentures) and a $3M NIH small-business grant from the National Heart, Lung and Blood Institute.  This money will be used to continue testing Bivacor’s Total Artificial Heart and expand the company’s workforce, as it prepares to begin its first human trials.

The device is unique in that it features a single moving part.  Two centrifugal impellers placed on a single rotor provide perfusion to the left and right sides of the body.  According to the company, active magnetic levitation provides precise, stable operation with no mechanical wear, while the device’s patented left-right flow-balancing system allows dynamic adaptation to changes in the patient’s physiology.

The centrifugal pump is powered by an external battery and controller connected via a transcutaneous cable. According to Bivacor, the device is small enough for a child but also powerful enough for a physically active adult.

Bivacor website: www.bivacor.com

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

 

Berlin Heals Publishes Results of First-In-Human C-MIC Study

Posted on by Posted in Berlin Heals, Cardiac Stimulation (other), Heart Failure (CHF), Microcurrent
Berlin Heals C-MIC

C-MIC Device. Image Credit: Berlin Heals

Berlin Heals just published the results of its first-in-human study of its C-MIC device, which was conducted in 10 NYHA Class III heart failure patients with LVEF<35%.  The C-MIC is an implantable electroceutical device intended to readjust the disturbed myocardial electrical gradient that, according to Berlin Heals, occurs in heart failure patients.

In the study follow‐ups, a rapid and significant signal of efficacy (P < 0.005) was present with improvements in LVEF, left ventricular end‐diastolic diameter, left ventricular end‐systolic diameter, and distance walked. For eight patients, NYHA classification improved from Class III to Class I (for seven, as early as 14 days post‐operatively); for one, to Class II; and for one, to Class II/III. 36‐Item Short‐Form Health Survey questionnaire scores also improved highly significantly.

Berlin Heals has now initiated a randomized, controlled trial in 100 DCM patients, which will take place in Germany, Austria, Serbia, and Poland.

In addition, the FDA has granted Breakthrough Device designation for the C-MIC system

Berlin Heals website: http://berlinheals.de/

Corvion’s Fully Implanted Left Ventricular Assist Device

Posted on by Posted in AIMD Companies, Circulatory Support, Corvion, EverHeart, Heart Failure (CHF)

Image Credit: Corvion

Corvion is a pre-clinical stage company based in Webster, Texas.  They are developing a fully-implantable LVAD that incorporates a highly efficient implantable rotary blood pump (Corvion claims 3X more efficient than competitors) coupled with a thin battery that gives 3 hours of free operation, and a robust transcutaneous energy transmission system.

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FDA/CE MR-Conditional Approvals for Impulse Dynamics’ OPTIMIZER Smart IPG

Posted on by Posted in Heart Failure (CHF), Impulse Dynamics, MRI-safe, My Portfolio

Impulse Dynamics – the company for which I am CTO and Executive VP – received MR-conditional approval (1.5 T head/limbs with peripheral coils) from both FDA and the European Union.

From the press release:

IMPULSE DYNAMICS ANNOUNCES FDA APPROVAL FOR MAGNETIC RESONANCE IMAGING FDA

Clears Potential Hurdle for Many Heart Failure Patients

MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval represents a significant advance because the population that benefits most from cardiac contractility modulation therapy (patients with moderate to severe HF) often requires advanced diagnostic imaging procedures.

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