Announcement follows device’s FDA 510(k) clearance
REHOVOT, Israel, April 29, 2022 /PRNewswire/ — Today, Xcardia Innovation Ltd., a privately held medical device company developing innovative pacemaker and defibrillator technology, announced the first-in-man use of its novel Xtractor device in patients undergoing lead extraction procedures. Charles J. Love MD, Director, Cardiac Rhythm Device Services and Professor of Medicine at Johns Hopkins Hospital, treated two patients in Baltimore, Marylandfollowing the device’s 510(k) clearance by the Food and Drug Administration February 2022.
“Xcardia is committed to providing innovative technology to physicians when performing this complex procedure. The Xtractor device is designed to provide convenience and control to physicians while giving patients peace of mind that the physician has additional advanced tools,” said Benny Rousso, PhD, CEO of Xcardia. “We are thrilled to have received 510(k) clearance from the FDA and to have the first cases at Johns Hopkins Hospital. We believe the unique features of this device have the potential to be a game-changer for patients. lead extraction procedures and we look forward to working with other medical institutions to bring the Xtractor to more patients.”
Removal of pacemaker and ICD leads is a complex procedure that involves the potential for many complications. The procedure is becoming increasingly necessary as an increasing number of patients are surviving their pacemakers. The Xtractor is designed to make the probe extraction procedure easier for surgeons, with more advanced control, incorporating motor-assisted activation, steering capability, pedal activation, and an advanced tip mechanism.
In February 2022the FDA has granted 510(k) clearance to Xtractor, allowing Xcardia to market and sell the device in United States. The Xtractor’s single-pedal device and feature set are designed for ease of use and provide more control for surgeons working to remove pacemaker leads through intravenous procedures. Maintaining control of tip orientation along the lead and away from veins is important, and motorized operation is designed to reduce physician fatigue. As a result, the revolutionary Xtractor device could play an important role in enabling more doctors to perform the procedure on more patients.
Xcardia Innovation Ltd. is a private medical device company that develops innovative cardiovascular technologies. Its latest product, Xtractor, received 510(k) clearance from the FDA in February 2022. Any forward-looking statement is subject to risks and uncertainties. Actual results may differ materially from anticipated results.
For more information, visit www.xcardia.com
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