Protaryx Medical announced that it received FDA 510(k) clearance for its proprietary Transseptal Puncture Device.
Baltimore-based Protaryx said clearance marks a significant advancement in its mission to redefine safe, efficient and reproducible left heart access. for cardiac interventions. It hopes to enable broader adoption and improved delivery of minimally invasive therapies.
Protaryx designed its technology to support zero-exchange delivery. It features a unique atraumatic design that reduces procedural steps and the need for rewiring. The device incorporates a highly echogenic, extendable atraumatic positioning probe and a standardized RF guidewire. It has compatibility with commercially available electrosurgical generators.
The company said its offering enables precise, site-specific transseptal puncture (TSP) to optimize access and positioning for cardiac interventions. Its system can reduce the risk of suboptimal device alignment, procedural complexity and downstream clinical complications.
According to Protaryx, an early first-in-human study of five subjects demonstrated procedural success in all cases. It saw no reported device-related adverse events, minimal crossing time and reduced fluoroscopic exposure. Cardiac interventions that the technology could facilitate include mitral valve repair and replacement, left atrial appendage closure and ablation to treat cardiac arrhythmias.
“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.”
