Protaryx Wins FDA Clearance for Transseptal Access Device

Protaryx Medical has received 510(k) clearance from the U.S. Food and Drug Administration for its proprietary transseptal puncture device, designed to enable safer and more consistent access to the left side of the heart.

The system features a zero-exchange delivery approach, eliminating the need for rewiring and reducing procedural steps. Its design includes an atraumatic tip, an extendable echogenic positioning probe, and a radiofrequency guidewire compatible with standard surgical equipment. These features aim to improve precision, reduce complications, and streamline cardiac procedures.

Early clinical data from a small first-in-human study showed 100% procedural success with no device-related adverse events, along with reduced procedure time and lower fluoroscopic exposure.

The clearance marks a key step toward commercialization in the US, with the company aiming to expand clinical adoption and improve outcomes in minimally invasive heart procedures.

20-04-2026