Xcardia Innovation announced the first-in-human use of its new Xtractor device in patients undergoing lead extraction procedures. Charles J. Love MD, Director, Cardiac Rhythm Device Services and Professor of Medicine at The Johns Hopkins Hospital, treated two patients in Baltimore, Maryland, following the Food and Drug Administration's 510(k) clearance of the device in February 2022.

"Xcardia is dedicated to delivering innovative technology to physicians as they perform this complex procedure. The Xtractor device is designed to offer convenience and control to physicians all while giving patients peace of mind that the physician has additional advanced tools available," said Benny Rousso, PhD, CEO of Xcardia. "We are pleased to have received the FDA 510(k) clearance and to have the first cases at The Johns Hopkins Hospital. We believe the unique features of this device have the potential to be a game-changer for lead extraction procedures and look forward to working with other medical facilities to offer the Xtractor to additional patients."

The removal of pacemaker and ICD leads is a complex procedure that involves the potential for numerous complications. The procedure is becoming more necessary as increasing numbers of patients outlive their pacemakers. The Xtractor is designed to make the lead extraction procedure easier for surgeons, with more advanced control, incorporating motor assisted activation, steering capability, pedal activation, and an advanced tip mechanism.

In February 2022, the FDA awarded 510(k) clearance to Xtractor, allowing Xcardia to market and sell the device in the United States. The Xtractor's unique pedal-operated device and collection of features are designed for ease of use and provide more control to surgeons working to remove pacemaker leads through intravenous procedures. Maintaining control of orientation of the tip along the lead and away from the veins is important, and motorized operation is designed to reduce physician fatigue. As a result, the game-changing Xtractor device could play an important role in enabling more physicians to perform the procedure on more patients.