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Implantable Minimally Invasive Cardiac Articles & Analysis

32 news found

Implicity Joins the AWS ISV Accelerate Program

Implicity Joins the AWS ISV Accelerate Program

Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has joined the Amazon Web Services (AWS) Independent Software Vendor (ISV) Accelerate Program, a co-sell program for AWS partners that provide software solutions that run on or integrate with AWS. The program helps AWS partners drive new business by directly connecting participating ISCs with the ...

ByImplicity


Life-Changing Watchman Procedure for Patient with Kidney Disease

Life-Changing Watchman Procedure for Patient with Kidney Disease

Like many people with atrial fibrillation (AFib), Sheldon Kittelson of Clarkfield, Minnesota, felt trapped between the fear of having a stroke and the fear of spending a lifetime on blood thinners. For people with AFib, blood doesn’t flow through the heart normally, which can result in a clot forming in the left atrial appendage (LAA) that can break loose and lead to a stroke. ...

ByEchoPixel, Inc.


V-Wave completes financing of $98m from syndicate of leading global healthcare investors

V-Wave completes financing of $98m from syndicate of leading global healthcare investors

Location: Caesarea, Israel and Agoura California V-Wave Ltd., a cardiovascular device company developing proprietary, minimally invasive interatrial shunt devicesfor treating patients with severe symptomatic heart failure (HF) and pulmonary arterial hypertension (PAH), announced today that it has successfully closed all remaining tranches of the Series C extension totaling $98M. The financing ...

ByV-Wave Ltd.


EBR Systems Raises AU$110M in Initial Public Offering on the Australian Securities Exchange (ASX)

EBR Systems Raises AU$110M in Initial Public Offering on the Australian Securities Exchange (ASX)

EBR Systems’ WiSE™ CRT System is world’s first and only wireless endocardial (inside the heart) left ventricle pacing system for heart failure EBR’s AU$110m ASX initial public offering today was strongly supported by new and existing institutional shareholders The new capital funds the completion of pivotal study, targeting FDA submission for approval in 2023 followed ...

ByEBR Systems, Inc.


EBR Systems Appoints Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler to the Board of Directors

EBR Systems Appoints Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler to the Board of Directors

Highlights: Dr Evans, Dr Steinhaus and Ms Drexler to join EBR Systems’ Board ahead of the planned A$110m IPO on the Australian Stock Exchange Board appointments follow the retirement of Mr Dave Stassen and Dr Leighton Read New EBR Systems’ Board consists of Mr Allan Will, Mr John McCutcheon, Dr Christopher Nave, Mr Trevor Moody, Dr Bronwyn Evans, Dr David Steinhaus and Ms ...

ByEBR Systems, Inc.


EBR Systems’ WiSE CRT System Demonstrates Technical Feasibility of Leadless Left Bundle Branch Area Pacing for Cardiac Resynchronization

EBR Systems’ WiSE CRT System Demonstrates Technical Feasibility of Leadless Left Bundle Branch Area Pacing for Cardiac Resynchronization

Published last month in the European Heart Journal, the case report details the successful deployment of the WiSE Electrode implanted in the LV septum of an 82-year-old male with tachyarrhythmia-induced cardiomyopathy. The patient exhibited improved electrical resynchronization on ECG and reported significant symptomatic improvement at six-month follow-up. This is the first reported case of ...

ByEBR Systems, Inc.


CorWave Attracts Global Talent, Strengthening Its Management Team in Preparation for Clinical Phase and Industrial Ramp Up

CorWave Attracts Global Talent, Strengthening Its Management Team in Preparation for Clinical Phase and Industrial Ramp Up

CorWave, a French medtech developing a next-generation heart pump, is recruiting top talent from throughout the world to strengthen its team. Two seasoned industry experts are joining the company: Paul Cornelison (USA) as Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs, and Michael Webb (Australia) as Vice President, Manufacturing. Paul Cornelison and Michael Webb have ...

ByCorWave


CorWave Presented First Successful In Vivo 60-Day Study on Its Innovative LVAD Cardiac Support Device

CorWave Presented First Successful In Vivo 60-Day Study on Its Innovative LVAD Cardiac Support Device

CorWave announced that it successfully completed its first 60-day preclinical study to evaluate its Left Ventricular Assist Device (LVAD). The results were presented at the 46th Annual Conference of the European Society for Artificial Organs (ESAO) in Hannover. Trevor Snyder, PhD, Senior Director, Translational and Clinical Research at CorWave, delivered an oral presentation, “CorWave ...

ByCorWave


FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

To regulate precise pacing from within the heart, WiSE uses a unique, wireless electrode the size of a grain of rice. It is implanted in the left ventricle wall during a minimally invasive procedure. ...

ByEBR Systems, Inc.


CARMAT announces the second center implanting its total artificial heart in the United States

CARMAT announces the second center implanting its total artificial heart in the United States

The implant was performed at UofL Health – Jewish Hospital by University of Louisville physicians within the framework of the U.S. Early Feasibility Study. CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage ...

ByCarmat


Orchestra BioMed Announces Peer-Reviewed Publication of MODERATO II Study Results Showing a Statistically Significant Reduction in Blood Pressure in Pacemaker-Indicated Patients Treated with BackBeat Cardiac Neuromodulation Therapy

Orchestra BioMed Announces Peer-Reviewed Publication of MODERATO II Study Results Showing a Statistically Significant Reduction in Blood Pressure in Pacemaker-Indicated Patients Treated with BackBeat Cardiac Neuromodulation Therapy

Double-blind, randomized trial data show a clinically meaningful and statistically significant net reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure at 6 months in treated vs. control patients Very high (85%) response rate to therapy despite 81% of treated patients having isolated systolic hypertension (ISH), a more dangerous and difficult to treat form of hypertension ...

ByOrchestra BioMed, Inc.


Adagio Medical Announces First-In-Human Use and Initiation of Multi-Center Study of Ultra-Low Temperature Cryoablation for Treatment of Recurrent Ventricular Tachycardia, Opening New Possibilities for High-Risk Patients

Adagio Medical Announces First-In-Human Use and Initiation of Multi-Center Study of Ultra-Low Temperature Cryoablation for Treatment of Recurrent Ventricular Tachycardia, Opening New Possibilities for High-Risk Patients

Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), today announced successful first-in-human use of ultra-low temperature cryoablation (ULTC) for the treatment of monomorphic VT. The two-hour mapping and ablation procedure was performed by Dr. Tom De Potter, MD, Associate Director, Cardiovascular Center ...

ByAdagio Medical, Inc.


Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

Alleviant Medical Inc., a privately-held medical device company, today announced one-month and three-month follow up data from the first in human clinical study (ALLEVIATE-HF-1) of its technology for the treatment of heart failure with preserved ejection fraction (HFpEF). The Alleviant System is a novel transcatheter device for the creation of a therapeutic interatrial shunt without a permanent ...

ByAlleviant Medical, Inc.


vMap`s Role in Optimizing Non-Invasive Radio-Ablation Therapy presented at ACC.21 and THRS 2021.

vMap`s Role in Optimizing Non-Invasive Radio-Ablation Therapy presented at ACC.21 and THRS 2021.

A dual-center study reported that vMap™, as part of a new, non-invasive workflow - with Varian’s CRA system - improved efficiency and precision for radio-ablation therapy in these study subjects. The study showed that the radio-ablation administered as a part of the enhanced workflow also significantly reduced ICD shocks for patients receiving the therapy. Presented by its lead ...

ByVektor Medical, Inc.


World’s First Leadless Left Bundle Branch Area Pacing Implant Utilizing EBR Systems’ WiSE CRT System

World’s First Leadless Left Bundle Branch Area Pacing Implant Utilizing EBR Systems’ WiSE CRT System

EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that Professor Pascal Defaye, Head of Rhythmology and Cardiac Stimulation Unit, CHU de Grenoble-Alpes, France, performed the world’s first successful Leadless Left Bundle Branch Area Pacing (LBBAP) implant performed utilizing the WiSE CRT System. LBBAP pacing has been ...

ByEBR Systems, Inc.


CardiacSense Medical Grade Watch receives CE Mark for continuous detection of Atrial Fibrillation

CardiacSense Medical Grade Watch receives CE Mark for continuous detection of Atrial Fibrillation

CardiacSense – a digital health company that developed and clinically verified a medical grade watch capable of detecting and remotely monitoring Atrial Fibrillation (A-Fib) and Heart Rate Variability (HRV) announced that it received the CE Mark for marketing & sales of the device in the European Union. The indications certified include “detection of Atrial Fibrillation ...

ByCardiacSense


Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ejection fraction ...

ByAlleviant Medical, Inc.


V-Wave completes financing of up to $98m from syndicate of leading Global Healthcare Investors

V-Wave completes financing of up to $98m from syndicate of leading Global Healthcare Investors

V-Wave Ltd., a cardiovascular device company developing proprietary, minimally invasive interatrial shunt devices for treating patients with severe symptomatic heart failure (HF) and pulmonary arterial hypertension (PAH), announced today that it has closed a Series C extension of up to $98M. The financing assures capital to complete clinical trials for the Ventura® Interatrial Shunt for the ...

ByV-Wave Ltd.


USPTO issues Patent for ground breaking polysaccharide technology platform to Endomedix.

USPTO issues Patent for ground breaking polysaccharide technology platform to Endomedix.

Endomedix announced today that it received a patent of 30 issued claims for its PLEXimine™ Polysaccharide Technology platform for a new class of biomaterials. The patent, “Methods and Compositions for Achieving Hemostasis and Stable Clot Formation”, also covers design features and mechanisms of action for its first product based on the technology. This technology platform ...

ByEndomedix, Inc.


Signifier® Medical Technologies appoints David Ritscher as Chief Engineer

Signifier® Medical Technologies appoints David Ritscher as Chief Engineer

Signifier Medical Technologies (“Signifier/the Company”), an innovator in the sleep-disordered breathing market, is pleased to announce the appointment of David Ritscher as Chief Engineer with immediate effect. He will be based in Boston and will be responsible for the Company’s hardware and software development, as well as data science capability. David’s appointment ...

BySignifier Medical Technologies Ltd

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