BioSig Technologies Inc said it would install a PURE EP System for evaluation at St. Elizabeth’s Medical Center in Boston.
The company said it initiated the new evaluation program under the leadership of Dr. Michael Orlov and aims to assess the PURE EP System during a series of physiologic pacing procedures.
Physiologic pacing is an emerging pacing technique designed to activate the normal cardiac conduction system and synchronize contraction of the ventricles. This approach to pacing the heart has demonstrated improved clinical and hemodynamic benefits beyond standard pacing techniques.
“The physiologic pacing procedure could benefit from advanced signal information to optimize lead placement and improve procedural outcomes,” said BioSig CEO Kenneth Londoner in a statement. “We look forward to combining our cardiac signal acquisition technology with advanced pacing therapies to treat more cardiac rhythm disorders.”
Londoner added: “This marks our 13th hospital partner, and we remain on track to achieve our 2021 goals of targeted market expansion.”
The PURE EP is a US FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, over 60 physicians have completed over 1,300 patient cases with the PURE EP System across 12 clinical sites.
The company recently completed its first multi-centered, prospective clinical trial and presented preliminary clinical data during the annual Heart Rhythm 2021 convention in July in Boston.
BioSig is in a focused commercial launch of the PURE EP System in the Northeast, Texas, and Florida and is in regular use in some of the country’s leading centers of excellence, including the Mayo Clinic in Rochester, Minnesota, and St. David’s Medical Center in Austin, Texas.
One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the US. According to the Centers for Disease Control and Prevention, atrial fibrillation causes more than 750,000 hospitalizations in the US each year, resulting in about $6 billion in healthcare spending annually.
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