Protaryx Medical has announced the completion of its first-in-human (FIH) study, assessing its advanced transseptal puncture technology.
Conducted on 3 December 2024 at Sanatorio Italiano de Asunción (Asunción, Paraguay), the study enrolled five patients under approval from the Research Ethics Committee of the Paraguayan Institute of Social Studies.
The procedures were performed by Adrian Ebner, head of the cardiovascular department at the Sanatorio Italiano Hospital, under the guidance by interventional cardiologist Gagan Singh (UC Davis Heath, Sacramento, USA).
The study met all procedural success endpoints with no adverse events. The device’s superior echogenicity facilitated rapid, targeted transseptal puncture with minimal fluoroscopic exposure, Protaryx Medical said in a press release. All five patients were discharged within 24 hours, reporting no complications and excellent therapeutic outcomes.
Singh commented: “The device substantially lowers the technical learning curve for targeted transseptal puncture due to its simplistic design, rapid echo visualisation of septal contact, and ease of negotiating the septum until the desired target is acquired.”
James Gammie, Protaryx co-founder and system chief of cardiac surgery at Johns Hopkins Health System (Baltimore, USA), stated: “The Protaryx device removes barriers for clinicians of all experience levels, making transseptal puncture safer and more efficient. It outperforms existing devices and sets a new standard for transseptal puncture.”
David Mester, CEO of Protaryx Medical, highlighted the broader implications of the milestone: “This achievement marks a pivotal step forward for Protaryx. We are excited to advance toward 510(k) submission and bring our innovative device to market, where it has the potential to redefine transseptal procedures.”
