Impulse Dynamics

29 articles about Impulse Dynamics

• Impulse Dynamics Completes $136M Financing Round

  2/14/2024

  Impulse Dynamics plc is proud to announce that it raised $136 million in financing to accelerate investment in global commercialization, technology, product innovation, and further development of clinical evidence.

• Impulse Dynamics Receives Full-Body MRI-Conditional Approval for Optimizer Smart Mini System

  10/30/2023

  Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure, announced it has received whole-body MRI-conditional approval for the Optimizer® Smart Mini system from the United States Food and Drug Administration.

• Impulse Dynamics Announces Leadership Changes

  9/19/2023

  Impulse Dynamics plc announced new leadership appointments, including Jason Spees to Chief Executive Officer, Shlomi Nachman to Chairman of the Board, and John Liddicoat, M.D., as a member of the Board of Directors.

• Impulse Dynamics Announces First Implant for CCM-D™ Clinical Trial

  5/18/2023

  Impulse Dynamics plc announced 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).

• Impulse Dynamics Announces 9,000th Patient Milestone Achieved With CCM® Therapy for Heart Failure

  5/15/2023

  Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced a worldwide milestone achievement with the 9,000th patient receiving the Optimizer® system for the treatment of moderate HF.

• Impulse Dynamics' Quality Management System Receives Certification Under European Union Medical Device Regulation

  3/22/2022

  Impulse Dynamics, a company dedicated to innovative treatments for chronic heart failure, is pleased to announce that it has successfully completed the requirements for certification of its quality management system under the new Medical Device Regulation now in force in the European Union.

• Impulse Dynamics Announces First Patient Enrolled in AIM HIGHer — Implantable Device Trial to Treat Heart Failure in Higher EF PopulationTrial Evaluates FDA-Designated Breakthrough Therapy for Patients Who Lack Treatment Options

  3/14/2022

  Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), today announced that the first patient has been enrolled in the quadruple-blinded sham-controlled AIM HIGHer IDE clinical study (Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction, NCT: 05064709) evaluating CCM® therapy for patients who have left ventricular ejection fraction ranging between 40% and 60% inclusive.

• Impulse Dynamics Announces CCM Therapy Delivered by the Optimizer System Wins R&D 100 Award

  10/6/2020

  Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced its innovative CCM ® therapy delivered by the Optimizer ® system received an award from the R&D 100 Awards, a prestigious program honoring research and development pioneers and their revolutionary ideas in science and tec

• Impulse Dynamics Announces CMS Proposed Rule Would Improve Medicare Coverage of CCM Therapy Delivered by the Optimizer System

  9/3/2020

  Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced that a proposed rule by the Centers for Medicare and Medicaid Services (CMS) could further streamline coverage of its innovative CCM ® therapy delivered by the Optimizer ® system. The proposed Medicare

• Impulse Dynamics Announces First Enrollment in Post-Approval Study of CCM Therapy Delivered by the Optimizer System

  3/17/2020

  Post-Approval Study will evaluate real-world safety and efficacy evidence for breakthrough heart failure therapy

• Impulse Dynamics Appoints Medical Director to Leadership Team

  3/10/2020

  Impulse Dynamics, a company dedicated to improving the lives of people with heart failure and developer of the innovative CCM™ therapy delivered by the Optimizer® Smart System, today announced the appointment of Ishu Rao, M.D., as medical director.

• Impulse Dynamics Secures $80.25 Million Financing

  12/3/2019

  Impulse Dynamics, developer of Optimizer® Smart System for delivering CCM™ therapy, announced the completion of an $80.25 million Series D financing with new investors

• Impulse Dynamics Secures Transitional Pass-through (TPT) Incremental Payment for the Optimizer Smart System

  11/5/2019

  2020 Payment Rules from the Centers for Medicare and Medicaid Services Bring CCM Therapy to Heart Failure Patients in the Outpatient Setting

• Impulse Dynamics Announces U.S. FDA Supplemental-PMA Approval of its Next Generation Optimizer® Smart System

  10/30/2019

  Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients

• Impulse Dynamics Announces Successful Implantation of First Patient Since FDA Approval of Optimizer® Smart System

  5/8/2019

  Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that the first patient to receive the Optimizer Smart System since the device was approved by the U.S. Food and Drug Administration was successfully implanted

• Impulse Dynamics Receives FDA Approval for Breakthrough Optimizer® Smart System Delivering CCM™ Therapy for Treatment of Heart Failure

  3/21/2019

  First-in-class device addresses significant unmet medical need in heart failure, modulates strength of heart muscle contraction rather than rhythm

• Impulse Dynamics Publishes FIX-HF-5C Clinical Trial Results

  5/10/2018

  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

• Impulse Dynamics' Optimizer Receives CFDA Approval in China

  12/18/2017

  The CFDA has approved Impulse Dynamics' Optimizer system for treatment of chronic heart failure.

• Impulse Dynamics Banks $45 Million for Heart Failure Technology

  5/12/2017

• Impulse Dynamics Completes $30 Million Financing Round

  5/13/2016