Cardialen gets FDA IDE nod for low-energy AFib treatment

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.

According to a news release, the low-energy method of electrical pulse delivery provides treatment in a manner that can potentially be less painful for the patient.

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 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. …

Read more
  • 0