The Latest Cardiac and Vascular News
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 […]
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 […]
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. […]
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 the Optimizer® Smart System, today announced the appointment of Ishu Rao, […]
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 […]
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 […]
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 supplement for its next generation, two-lead Optimizer Smart System for […]
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 Administration was successfully implanted. The procedure, which occurred on Monday, May […]
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 (link to FDA announcement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm). Designed to address a significant unmet […]
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 therapy to restore a normal timing pattern of the heartbeat. […]
