Protaryx Medical, a medical device company developing access solutions for minimally invasive left-heart procedures, has submitted a 510(k) premarket notification to the FDA for its proprietary Transseptal Puncture Device.
The Protaryx Transseptal Puncture Device is designed to provide zero-exchange delivery of left-atrial therapy devices. It features an echogenic, extendable atraumatic positioning probe combined with a standardized RF guidewire compatible with commercially available electrosurgical generators.
The company’s first-in-human (FIH) study, conducted on December 3, 2024, in Asunción, Paraguay (five patients), achieved all procedural success endpoints, no adverse events, substantially reduced fluoroscopic exposure and rapid patient discharge.
With the 510(k) submission, Protaryx is now advancing toward U.S. regulatory clearance and the commercial launch of its device.
