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 […]
Tag: Impulse Dynamics
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, […]
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 […]
Impulse Dynamics Appoints Medical Director to Leadership Team
Ishu Rao, M.D., brings wealth of clinical expertise during time of rapid company growth MOUNT LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure and developer of the innovative CCM™ therapy delivered by […]
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 […]
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 […]
Impulse Dynamics Announces U.S. FDA Supplemental-PMA Approval of its Next Generation Optimizer® Smart System
Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients MOUNT LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering CCM™ (Cardiac Contractility Modulation) therapy, announced today that it has received FDA approval of a PMA […]
Impulse Dynamics Announces Successful Implantation of First Patient Since FDA Approval of Optimizer® Smart System
NEW YORK, May 8, 2019 /PRNewswire/ — 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 […]
Impulse Dynamics Receives FDA Approval for Breakthrough Optimizer® Smart System Delivering CCM™ Therapy for Treatment of Heart Failure
ORANGEBURG, New York, March 21, 2019 /PRNewswire/ — 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 […]
FDA approves new device for treating moderate to severe chronic heart failure in patients
SILVER SPRING, Md., March 21, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization […]