Cardialen announced today that 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.
The low-energy method of electrical pulse delivery provides treatment in a manner that can potentially be less painful for the patient, Cardialen said in a news release.
Cardialen’s IDE trial builds on a previous study conducted by the company along with a companion study currently enrolling patients across seven medical centers in Australia, the company said.
The study’s principal investigator, Dr. John Hummel, said in the news release that he believes MPT has the potential to improve heart failure outcomes in AFib patients receiving a cardiac resynchronization therapy defibrillator (CRT-D) implant. Hummel is a leading clinical researcher at The Ohio State University Wexner Medical Center.
“I am pleased with Cardialen’s progress,” Cardialen founder Igor Efimov said in a news release. “This will build on the approximately 100 patients already treated. MPT has the potential to offer patients an option of pain-tolerable cardioversion.”