Coronary sinus

Positive results from first-in-human completely leadless CRT in the US, published in The Journal of the American College of Cardiology

Retrieved on: 
Wednesday, October 25, 2023

The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE® CRT Electrode in the left ventricle of the heart.

Key Points: 
  • The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE® CRT Electrode in the left ventricle of the heart.
  • This first use in the US of the WiSE CRT System as a first-line therapy is a future market expansion opportunity for EBR.
  • "It's great to see these positive results being published in a world-leading cardiology journal, such as The Journal of the American College of Cardiology," said John McCutcheon, President & CEO of EBR Systems.
  • "This case study highlights the potential of totally leadless CRT for patients struggling with traditional CRT, but also beyond these patient groups, the 64 million heart failure patients across the globe."

WiSE® Technology to Feature in Upcoming APHRS Scientific Session

Retrieved on: 
Thursday, November 17, 2022

The annual conference is a premier event featuring industry workshops and a core scientific programme delivered by international and regional speakers.

Key Points: 
  • The annual conference is a premier event featuring industry workshops and a core scientific programme delivered by international and regional speakers.
  • Five abstracts featuring WiSE have been accepted for presentations, highlighting the technology's position at the forefront of innovation in the cardiac rhythm management landscape.
  • The abstracts presented at this scientific session strengthen the body of data supporting WiSE while promoting our technology to a wide audience including industry partners and the broader scientific community."
  • EBR Systems' WiSE technology is the world's only wireless, endocardial (inside the heart) pacing system in clinical use for stimulating the heart's left ventricle.

Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Retrieved on: 
Tuesday, August 23, 2022

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology.

Key Points: 
  • Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology.
  • Miracor is currently recruiting 144 patients in PiCSO-AMI-I, a landmark European randomized controlled trial, with comparable endpoints as the approved US trial.
  • Miracor Medical was originally founded by a cardiac surgeon at the Medical University of Vienna, Austria, Professor emeritus Werner Mohl.
  • 8(1): p. 222-237
    Egred, M., et al., Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study.

Miracor Medical starts 2nd randomized study, targeting expanded indications. 300 patients have been treated with PiCSO®

Retrieved on: 
Tuesday, March 29, 2022

It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart.

Key Points: 
  • It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart.
  • We know that improving outcomes for patients with large heart attacks remains an important unmet need, especially because these patients often progress to develop heart failure."
  • In the study, patients will be randomized 2:1 to a group receiving PiCSO as an adjunct to their primary PCI procedure versus a conventional strategy of primary PCI alone.
  • Furthermore, OxAMI-PICSO3 showed an early improvement in coronary microvascular function post PiCSO treatment in both anterior and inferior STEMI patients.

Miracor Medical starts 2nd randomized study, targeting expanded indications. 300 patients have been treated with PiCSO®

Retrieved on: 
Tuesday, March 29, 2022

It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart.

Key Points: 
  • It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart.
  • We know that improving outcomes for patients with large heart attacks remains an important unmet need, especially because these patients often progress to develop heart failure."
  • In the study, patients will be randomized 2:1 to a group receiving PiCSO as an adjunct to their primary PCI procedure versus a conventional strategy of primary PCI alone.
  • Furthermore, OxAMI-PICSO3 showed an early improvement in coronary microvascular function post PiCSO treatment in both anterior and inferior STEMI patients.

Medtronic receives FDA expanded approval for cardiac cryoablation catheters for pediatric treatment of a common heart rhythm condition

Retrieved on: 
Friday, February 18, 2022

AVNRT is the most common form of supraventricular tachycardia (SVT), and is a life-threatening abnormal heart rhythm, with 89,000 cases each year and growing.

Key Points: 
  • AVNRT is the most common form of supraventricular tachycardia (SVT), and is a life-threatening abnormal heart rhythm, with 89,000 cases each year and growing.
  • The Freezor family of cryoablation catheters also includes the Freezor MAX cardiac cryoablation catheter, which is approved for use in conjunction with the Arctic Front Advance cryoballoon for the treatment of atrial fibrillation (AF).
  • Medtronic has pioneered cryoablation technology, with an industry-leading and extensive body of evidence, including proven safety and efficacy in treating AF and AVNRT.
  • Experience and results during transition from radiofrequency ablation to cryoablation for treatment of pediatric atrioventricular nodal reentrant tachycardia PACE Pacing Clin.

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

Retrieved on: 
Tuesday, November 23, 2021

Australian investors strong appetite for healthcare stock continues with the AU$110M listing of cardiovascular medical device company, EBR Systems, at 11am AEDT November 24 on the Australian Securities Exchange (ASX).

Key Points: 
  • Australian investors strong appetite for healthcare stock continues with the AU$110M listing of cardiovascular medical device company, EBR Systems, at 11am AEDT November 24 on the Australian Securities Exchange (ASX).
  • Its been wonderful to see such strong investor support for EBRs initial public offering, said John McCutcheon, President and CEO of EBR Systems.
  • In October, EBR successfully completed an AU$110M underwritten capital raise, which was strongly supported by new and existing institutional shareholders.
  • Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing.

Neovasc Announces Third Quarter 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 9, 2021

VANCOUVER and MINNEAPOLIS, Nov. 09, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Neovasc, Inc. ("Neovasc" or the "Company") ( NASDAQ , TSX : NVCN) today reported financial results for the third quarter ended September 30, 2021.

Key Points: 
  • VANCOUVER and MINNEAPOLIS, Nov. 09, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Neovasc, Inc. ("Neovasc" or the "Company") ( NASDAQ , TSX : NVCN) today reported financial results for the third quarter ended September 30, 2021.
  • Neovasc continued to make good progress with its value creation strategies during the third quarter.
  • Financial results for the third quarter ended September 30, 2021
    Revenues increased by 12% to $703,420 for the three months ended September 30, 2021, compared to revenues of $626,418 for the same period in 2020.
  • Neovasc will be hosting a conference call and audio webcast today at 4:30 pm ET to discuss these results.

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

Retrieved on: 
Monday, November 8, 2021

EBR Systems, Inc., developer of the worlds only wireless cardiac pacing system for heart failure, today announced the appointment of Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler to the Board as Independent Non-Executive Directors.

Key Points: 
  • EBR Systems, Inc., developer of the worlds only wireless cardiac pacing system for heart failure, today announced the appointment of Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler to the Board as Independent Non-Executive Directors.
  • Ms Drexler brings an array of operational and entrepreneurial experience to EBR Systems Board.
  • I am very excited to welcome Dr Evans, Dr Steinhaus and Ms Drexler to our Board of Directors, who together bring a wealth of clinical and commercial experience across the healthcare industry, which will be of significant value to EBR Systems.
  • Dr Steinhaus and Ms Drexler join Mr Allan Will, Mr John McCutcheon, Dr Christopher Nave and Mr Trevor Moody on the EBR Systems Board.

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

Retrieved on: 
Wednesday, October 27, 2021

EBR Systems, Inc. , developer of the worlds only wireless cardiac pacing system for heart failure, today announced the publication of a case report demonstrating the WiSE CRT Systems ability to successfully deliver leadless Left Bundle Branch Area Pacing (LBBAP).

Key Points: 
  • EBR Systems, Inc. , developer of the worlds only wireless cardiac pacing system for heart failure, today announced the publication of a case report demonstrating the WiSE CRT Systems ability to successfully deliver leadless Left Bundle Branch Area Pacing (LBBAP).
  • WiSE is the only leadless pacing technology able to achieve LBBAP, a novel form of conduction system pacing which can reverse left bundle branch block and deliver cardiac resynchronization therapy (CRT).
  • WiSE is the first and only leadless pacing system that can deliver physiologic, conduction system pacing without leads.
  • Cardiac Resynchronization Therapy by Left Bundle Branch Area Pacing in Patients with Heart Failure and Left Bundle Branch Block.