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Atraverse wins FDA nod for left-heart access device

Atraverse Medical announced today that the FDA cleared its Hotwire radiofrequency guidewire left-heart access device.

The novel device enables zero exchange left-heart access while acting as a rail for catheter-based therapy systems. Steven Mickelsen, the founder of Farapulse, invented the Hotwire system with co-founder Eric Sauter. It’s the latest good news for a Mickelsen-backed company after his Field Medical pulsed-field ablation company treated its first patients last week.

Atraverse Medical’s device features universal sheath compatibility and optimized radiofrequency (RF) technology. The company aims for Hotwire to improve outcomes while streamlining procedural workflows.

“The FDA clearance of the Hotwire underscores our dedication to medical innovation and our commitment to improving the standard of care for procedures requiring transseptal access including endocardial ablation, left atrial appendage closure, and mitral valve repair,” Mickelsen said in a news release.

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