FDA OKs Protaryx’s Transseptal Puncture Device

Protaryx Medical, a company developing disruptive access solutions for minimally invasive left-heart procedures, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Transseptal Puncture Device.

The system was designed for zero-exchange delivery and features an atraumatic design that reduces procedural steps as well as the need for rewiring. The device uses an echogenic, extendable atraumatic positioning probe and standardized RF guidewire compatible with commercially available electrosurgical generators.

It allows precise, site-specific transseptal puncture (TSP) to optimize access and positioning for cardiac interventions. The company said it reduces the risk of suboptimal device alignment, procedural complexity, and downstream clinical complications.

In an early first-in-human study, the device showed procedural success in every case with no reported device-related adverse events, minimal crossing time, and reduced fluoroscopic exposure. Now that FDA clearance has been gained, Protaryx plans to begin U.S. commercialization and expand clinical adoption.

“Receiving FDA 510(k) clearance is a defining moment for Protaryx,” said David Mester, CEO of Protaryx Medical. “This achievement reflects the dedication of our team to solving one of the most critical challenges in safe and efficient transseptal access procedures. We are now positioned to bring this transformative technology to physicians and patients across the United States.”