Heart Failure (CHF) – Page 4 – The World of Implantable Devices

Medtronic Receives FDA Approval for World’s First Quadripolar Active Fixation Left Heart Lead

Posted on May 1, 2019 by David Prutchi Posted in Cardiac Pacing, Heart Failure (CHF), Medtronic

Image Credit: Medtronic

Medtronic announced today that it has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left heart lead, and is designed for precise lead placement and stability. Medtronic said that the lead will be commercially available in the U.S. in summer 2019.

Biotronik Launches Single-Pass Dual-Chamber Defibrillation System

Posted on April 30, 2019 by David Prutchi Posted in Biotronik, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia

Biotronik announced yesterday the full commercial launch of the Acticor device family, including Acticor DX and CRT-DX devices. The unique feature of the system is the single-pass lead with its floating atrial sensing rings. According to the press release:

“When implanted with Biotronik’s Plexa ProMRI S DX lead, the hybrid ICD Acticor systems offer dual-chamber diagnostics without the need for an atrial lead. Importantly, all three Acticor DX devices feature a new DF4 header configuration with a penta-polar electrode lead cable design that simplifies the implant procedure for physicians.”

Leviticus Cardio’s Coplanar Energy Transfer for Powering Ventricular Assist Devices

Posted on April 22, 2019 by David Prutchi Posted in Coplanar Energy Transfer, Heart Failure (CHF), Jarvik Heart, Leviticus Cardio, Ventricular Assist Device, Wireless Power Transmission

Image Credit: Composite of images by Leviticus Cardio

Leviticus Cardio, a company based in Petach Tikva, Israel, has been developing a wireless power transfer technology that they call “Coplanar Energy Transfer” (CET). The system supports high-efficiency (up to 75%) power transfer levels of up to 30 Watts, making it suitable for powering ventricular-assist devices.

Like other transcutaneous energy transfer systems, Leviticus is used on inductive power transfer between an external primary coil and an implanted secondary coil. However, instead of the traditional pancake coil subcutaneous implant, the CET coil is placed around the lung. The unique engineering of the coplanar energy transfer system is characterized by two large rings utilizing a coil-within-the-coil topology, ensuring robust resonance energy transfer Continue reading→

FDA Approves breakthrough Optimizer® Smart System Delivering CCM™ Therapy for Treatment of Heart Failure

Posted on March 22, 2019 by David Prutchi Posted in Cardiac Contractility Modulation, Cardiac Stimulation (other), David Prutchi's Portfolio, Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics

I have led the development of devices to deliver CCM™ therapy from the very beginning, so it is with great pleasure and pride that I share with you the exciting news that Impulse Dynamics just received approval from the United States Food and Drug Administration (FDA) for our Optimizer® Smart System for heart failure patients! An official FDA announcement was made through the publication of a press release that you can find here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm.

Impulse Dynamics’ press release is as follows:

Impulse Dynamics receives FDA approval for breakthrough Optimizer® Smart System delivering CCM™ therapy for treatment of heart failure

Orangeburg, New York, March 21, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System.

Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device designation from the FDA in 2015. It was the first breakthrough device to go before the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee, on Dec. 4, 2018, receiving a 12-0 vote on the benefit-to-risk ratio of the device.

“With the FDA’s approval of the Optimizer System for the delivery of CCM, we finally have available in the US an effective device-based therapy for advanced heart failure patients with mildly to moderately reduced left ventricular ejection fractions who are not eligible for CRT,” said Professor William T. Abraham, MD, Professor of Medicine, Physiology, and Cell Biology, and College of Medicine Distinguished Professor at the Ohio State University Wexner Medical Center. “The Optimizer System, along with guideline-directed medical therapies, can improve the lives of many heart failure patients in the US who previously did not have access to this therapy. As such, it represents a real game-changer for these patients.”

The Optimizer Smart System is the first and only CCM device approved by the FDA to improve 6-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT, and have an LVEF ranging from 25% to 45%. Only 30 percent of moderate to severe chronic heart failure patients are candidates for CRT, which historically has left 70 percent of patients with few options to help them manage their disease.

“FDA approval is the culmination of many years of clinical development for this disruptive technology, addressing a significant unmet need in today’s heart failure treatment paradigm,” commented Dr. Daniel Burkhoff, Impulse Dynamics’ Medical Advisor. “We continue to develop the technology with ongoing clinical trials designed to evaluate CCM therapy in additional heart failure populations.”

CCM is a unique electrical pulse delivered during the absolute refractory period, which is just after the heart contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm.

Dr. Simos Kedikoglou, Impulse Dynamics’ CEO, announced that the Company will launch the device in the US later this year. “We are extremely excited that the Optimizer Smart System with CCM therapy is now available in the United States,” he said. “We look forward to growing our commercial presence in the US and globally.”

About the Optimizer and CCM Therapy
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 80 papers in leading medical journals.

About Impulse Dynamics
Impulse Dynamics is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, and Asia. For more information please visit www.impulse-dynamics.com.

Impulse Dynamics (USA), Inc.
30 Ramland Road South, Suite 204
Orangeburg, NY 10962

FDA Approves Biotronik’s Acticor and Rivacor CRM Device Families. Biotronik Changes IPG Shape?

Posted on March 18, 2019 by David Prutchi Posted in Biotronik, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia

Image Credit: Biotronik

FDA has approved Biotronik’s Acticor and Rivacor high-voltage CRM Device Families. According to the press release the six new tachycardia solutions include Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX.

The Acticor and Rivacor IPGs have a smooth, elliptical “BIOshape” and are the smallest and slimmest 3 Tesla (3T) MR-conditional CRM devices currently on the market. The devices also feature extended longevity—nearly 15 years for VR-T, 13.5 years for DR-T, 14 years for DX and nine years for CRT.

The Acticor family offers Biotronik’s “DX technology”, which provides atrial diagnostics without an atrial lead. DX systems can detect silent atrial fibrillation for stroke prevention, enhance diagnostic accuracy for better clinical decision-making and allow for dual-chamber supraventricular tachycardia (SVT) discrimination to prevent unnecessary shocks.

The Rivacor HF-T QP offer 20 LV pacing vectors and cardiac resynchronization therapy (CRT) optimization with intelligent CRT AutoAdapt programming to automatically adjust to changes in patient conditions.

Acticor and Rivacor also feature MRI AutoDetect technology, which automatically recognizes when a patient enters an MRI environment and adjusts therapy for the duration of the scan.

Biotronik’s website: https://www.biotronik.com

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

Posted on March 4, 2019 by David Prutchi 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

VisCardia’s VisONE® Asymptomatic Diaphragmatic Stimulation

Posted on February 12, 2019 by David Prutchi Posted in Asymptomatic Diaphragmatic Stimulation, Heart Failure (CHF), Viscardia

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.

Berlin Heals’ C-MIC Microcurrent Device

Posted on February 12, 2019 by David Prutchi Posted in Berlin Heals, Heart Failure (CHF), Microcurrent

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/

FIX-HF-5C Late-Breaking Clinical Trial Data Presented at HRS 2018 with Simultaneous Publication in the Journal of the American College of Cardiology: Heart Failure

Posted on May 10, 2018 by David Prutchi Posted in Heart Failure (CHF), Impulse Dynamics, My Portfolio

From Impulse Dynamics today:

FIX-HF-5C Late-Breaking Clinical Trial Data Presented at HRS 2018 with Simultaneous Publication in the Journal of the American College of Cardiology: Heart Failure

Orangeburg, New York, May 10, 2018 – Impulse Dynamics (USA), Inc. announced results from its FIX-HF-5C randomized, Controlled Trial of Cardiac Contractility Modulation in Heart Failure. The study results were presented by Prof. William Abraham, MD, Professor of Internal Medicine and Director, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, at the Heart Rhythm Society Late-Breaking Clinical Trials today in Boston, Massachusetts, with a simultaneous publication in the JACC: Heart Failure Journal.

CCM™ is a therapy unique to the Optimizer® family of devices that deliver electrical signals to the heart that are intended to reduce symptoms and improve exercise tolerance in patients with heart failure. The FIX-HF-5C study was designed to prospectively confirm a subgroup analysis of the prior FIX-HF-5 pivotal trial, showing that CCM™ significantly improved exercise tolerance and quality of life in patients with NYHA class III and IV heart failure symptoms, ejection fraction 25-45%, and a QRS <130ms. A Bayesian statistical analysis plan was developed to combine the data already available from the original FIX-HF-5 study with the FIX-HF-5C study data. The results presented today at HRS supplement and confirm the results from the prior study, meeting the safety and effectiveness objectives of the study.

Highlights of the results include:

CCM™ is safe; the study met its primary and secondary safety endpoints.

Patients receiving CCM™ showed significantly better exercise tolerance and quality of life compared to their control-group counterparts.

The composite of cardiovascular deaths and heart failure hospitalizations was statistically significantly reduced in comparison to the control group.

Clinical effectiveness was even greater in patients with EF >35%.

“The results of the FIX-HF-5C study exceeded my expectations by not only confirming the benefits of CCM™ on important patient-centered endpoints such as exercise capacity and quality of life, but also in demonstrating the potential for CCM™ to reduce heart failure morbidity and mortality” said Prof. Abraham. “These findings support the use of CCM™ as a breakthrough therapy for heart failure patients with moderately reduced left ventricular systolic function and narrow QRS durations, who currently have no other options for improvement.”

“I would like to thank the FIX-HF-5C Study Investigators and the Impulse Dynamics’ team for completing this important study with its very encouraging results.” said Dr. Simos Kedikoglou, Impulse Dynamics’ CEO.“We anticipate submission of the final PMA module to the U.S. FDA in June 2018.”

About the Optimizer® and CCM™ Therapy
CCM™ is the brand name for the nonexcitatory electrical pulses delivered by the implantable Optimizer® device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer® system has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India and several other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 70 publications in leading medical journals. The Optimizer® is limited to Investigational use only in the United States.

About Impulse Dynamics
Impulse Dynamics N.V. is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, and Asia. For more information please visit http://www.impulse-dynamics.com

Impulse Dynamics (USA), Inc.
30 Ramland Road South, Suite 204
Orangeburg, NY 10962

For media enquiries
Mrs. Sharon Alon
Tel: +1-347-761-3342

First Implant of Impulse Dynamics’ OPTIMIZER Smart IPG

Posted on November 24, 2016 by David Prutchi Posted in Cardiac Stimulation (other), Heart Failure (CHF), Impulse Dynamics, My Portfolio

OPTIMIZER Smart IPG David Prutchi PhD

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.

Dr. Markus Reinartz at the Herz-Jesu Hospital in Dernbach, Germany.
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.

Abrupt Increase in Thoratec HeartMate II LVAD Thrombosis Reported in NEJM

Posted on November 30, 2013 by David Prutchi Posted in Circulatory Support, Heart Failure (CHF), Thoratec

A study published on Nov 27, 2013 in the New England Journal of Medicine reports on a sudden increase in the incidence of pump thrombosis with the Thoratec HeartMate II LVAD.

The study shows an unexplained increase in thrombosis when comparing LVAD patients at three centers from January 2004 to March 2011 vs. those implanted March 2011 to April 2013. During these periods, the rate of confirmed thrombosis three months after LVAD implantation increased sharply from 2.2% to 8.4%, and median time from implantation until the development of blood clots with the devices decreased from 18.6 to 2.7 months. The increasing incidence of early thrombosis with the HeartMate II is reported to be associated with substantial morbidity and mortality.

The study was initiated by the outcome of a quality review whereby the Cleveland Clinic detected an unexpected abrupt increase in the incidence of device thrombosis. The results were reported to Thoratec and the FDA. To confirm these findings, implant data were reviewed for 895 HeartMate II devices implanted in 837 patients from 2004 to 2013 at the Cleveland Clinic, Washington Barnes-Jewish Hospital, and Duke University Medical Center. The frequency of device thrombosis increased steeply around March 2011 at the three institutions.

Dr. Randall C Starling (Cleveland Clinic, OH), the first listed author, told heartwire that the research groups are working with the Thoratec to try to identify an explanation for this issue.

European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure

Posted on November 21, 2013 by David Prutchi Posted in BioControl, Cardiac Pacing, Cardiac Stimulation (other), CardioMEMS, CVRx, Heart Failure (CHF), Impulse Dynamics, Spinal Cord Stimulation, Vagus Nerve Stimulation

Implantable devices for the treatment of heart failure, David Prutchi, PhD

A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association.

The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:

Several new devices for the treatment of heart failure (HF) patients have been introduced and are increasingly used in clinical practice or are under clinical evaluation in either observational and/or randomized clinical trials. These devices include cardiac contractility modulation, spinal cord stimulation, carotid sinus nerve stimulation, cervical vagal stimulation, intracardiac atrioventricular nodal vagal stimulation, and implantable hemodynamic monitoring devices. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients.

The report places special focus to patients with HF New York Heart Association (NYHA) Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex (who are candidates for treatment with cardiac resynchronization therapy – CRT).

Continue reading→

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

Posted on October 12, 2013 by David Prutchi 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.

Enopace Receives Additional $5M Investment for Development of Stimulator for Treatment of Heart Failure

Posted on July 15, 2013 by David Prutchi Posted in Aortic Stimulation, Enopace Biomedical, Heart Failure (CHF), Sorin, Yossi Gross (Rainbow Medical)

From Patent Application Publication: US 2011/0137370 A1

Sorin recently announced a $5 million investment in Israeli startup Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure. Back in October 2011 Sorin invested $7 million to finance the initial clinical studies of Enopace’s technology as well as ongoing product development.

Very scant details are available besides that it is developing a neuromodulation system to treat patients with congestive heart failure. According to the company, its technology consists of a minimally invasive, implantable neurostimulation device that increases cardiac efficiency by reducing left ventricular workload.

From Enopace’s patent applications, it seems that Enopace’s device consists of a stimulation unit that is placed within the aorta close to the heart, and which is driven wirelessly from a coil that is placed within a vein closeby to the artery. The transmitting coil is in turn driven from an implanted control unit that is implanted subcutaneously.

Israeli business news website “Globes” interviewed Enopace’s CEO Amir Dagan, and reported in February 2013:

Continue reading→

Neuromodulation Startup NeuroTronik Raises $13.1M for Development of System for Treating Acute Heart Failure Syndrome

Posted on July 14, 2013 by David Prutchi Posted in Heart Failure (CHF), Neural Stimulation, NeuroTronik

NeuroTronik, a recent spin-off from Synecor, a Chapel Hill business accelerator, announced that it has raised $13.1M for the development of a neuromodulation system intended for the treatment of acute heart failure syndrome.

Douglas Reed, a partner in the VC group backing NeuroTronik said that the device aims to shorten hospital stays and reduce the need of patients to return to the hospital a few weeks later. According to Reed:

“It’s a way of stimulating the heart to increase the pumping effectiveness, the effectiveness of the contractions, so it improves cardiac function while the device is in place.”

Category Archives: Heart Failure (CHF)