The FDA has cleared a device aimed at improving access to the heart’s outer surface for diagnostic and therapeutic interventions without the use of an exposed needle.
The device, called ViaOne and developed by CardioVia, aims to eliminate the need for an uncontrolled sharp needle to reduce the risk of heart perforation, a complication with current percutaneous techniques, according to an April 8 news release from the company.
The FDA clearance follows clinical evidence supporting the device’s safety and effectiveness, including a recent clinical study published in JACC: Clinical Electrophysiology. The company is preparing for an initial commercial launch of the device at cardiac centers across the U.S., the release said.
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