Cardialen in the News
Cardialen Receives FDA Approval to Conduct Clinical Trial of Low-Energy Atrial Fibrillation Treatment
EP Lab Digest
Minneapolis, Nov. 17, 2021 – Cardialen, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin a clinical trial of its MultiPulse™ Therapy (MPT™) to treat paroxysmal and persistent atrial fibrillation (AF).
Published: 2021
Cardialen gets FDA IDE nod for low-energy AFib treatment
Mass Device
Cardialen announces it received FDA investigational device exemption (IDE) approval for its MultiPulse therapy platform. Minneapolis-based Cardialen designed its MultiPulse therapy (MPT) to treat paroxysmal and persistent AFib through a sequence of low-energy electrical pulses that restore abnormally rapid heart rates to a normal rhythm.
Published: 2021
Cardialen gets FDA approval for study of its Multipulse Therapy for AF
Cardiac Rhythm News
Cardialen has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF). MPT is delivered as a sequence of low-energy electrical pulses designed to restore abnormally rapid heart rates to a normal rhythm in a manner potentially less painful to the patient.
Published: 2021
When They Go High We Go Low: Using Low Energy to Treat AFib
MD+DI
Cardialen is fighting to get approval for its treatment of atrial fibrillation. The Minneapolis, MN-based company has won a nod from FDA for an IDE to begin a clinical trial of its Multipulse therapy (MPT). Cardialen seeks to use Multipulse to provide a therapy for those patients already receiving an implantable cardiac resynchronization therapy (CRT) defibrillator device.
Published: 2021
Cardialen wins FDA IDE approval for low-energy pulse therapy
BioWorld
The FDA granted Cardialen Inc. an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF). MPT is a low-energy electrical pulse therapy aimed at restoring abnormally rapid heart rates, such as AF, to a regular rhythm to reduce the potential for high-energy shocks. Studies have shown that almost 1 in 4 patients experience anxiety or depression after receiving an implantable cardioverter defibrillator (ICD).
Published: 2021
Medtech Firm Cardialen to Kick Off Fifth Clinical Trial
Twin Cities Business
Minneapolis-based medtech company Cardialen Inc. is set to begin the fifth clinical trial of a new treatment for irregular heartbeats in heart failure patients. Last week, the company announced that it has received approval from the U.S. Food and Drug Administration to begin a clinical trial of a new process known as “MultiPulse Therapy.” Cardialen’s technology would work in concert with existing implantable heart failure devices on the market, says CEO and president Jeff Peters.
Published: 2021