Tag: Impulse Dynamics

IMPULSE DYNAMICS RECEIVES APPROVAL TO SELL OPTIMIZER CCM DEVICES IN CHINA

NMPA Clears the Way for Impulse Dynamics to Deliver Hope for Heart Failure Population MARLTON, N.J., Feb. 22, 2021 (GLOBE NEWSWIRE) — Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced that the National Medical Products Administration (NMPA) approved the application for […]

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 […]

Impulse Dynamics Announces First Heart Failure Patient Treated With CCM Therapy in Brazil

Breakthrough Therapy Now Commercially Available in South America’s Most Populous Country MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to helping healthcare providers improve the lives of people with heart failure, today announced the first patient in Brazil was treated with its innovative CCM® therapy delivered by the Optimizer® system. The patient was treated […]

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

Breakthrough heart failure therapy recognized as a revolutionary innovation MARLTON, N.J.–(BUSINESS WIRE)–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 […]

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

Rule would give Medicare patients immediate access to breakthrough heart failure therapy MT. LAUREL, N.J.–(BUSINESS WIRE)–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 […]

Impulse Dynamics Announces Publication of Data from FIX-HF-5C2 Study Evaluating the Two-Lead Optimizer System

Availability of the two-lead device represents a significant advancement in the development of cardiac contractility modulation therapy for patients with heart failure MT. LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a medical device company dedicated to improving the lives of heart failure patients, today announced the publication of the FIX-HF-5C2 study in Circulation: Heart […]

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

Post-Approval Study will evaluate real-world safety and efficacy evidence for breakthrough heart failure therapy MT. LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced the first enrollment in a post-approval study of its innovative CCM™ therapy delivered by the Optimizer® system. […]

Impulse Dynamics Secures $80.25 Million Financing

Funding to Accelerate Commercialization of the Optimizer Smart System for Heart Failure MOUNT LAUREL, N.J.–(BUSINESS WIRE)–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. The proceeds will be used primarily to facilitate U.S. commercialization of the […]

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

2020 Payment Rules from the Centers for Medicare and Medicaid Services Bring CCM Therapy to Heart Failure Patients in the Outpatient Setting MOUNT LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering Cardiac Contractility Modulation (also known as CCM™ therapy), announced that it has secured transitional […]