BALTIMORE--(BUSINESS WIRE)--Protaryx Medical, a pioneer in medical device innovation, is proud to announce the successful completion of its First-in-Human (FIH) study, demonstrating the transformative potential of its advanced transseptal puncture technology. Conducted on December 3, 2024, at Sanatorio Italiano de Asunción in 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 Dr. Adrian Ebner, Head of the Cardiovascular Department at the Sanatorio Italiano Hospital, under the guidance by interventional cardiologist Dr. Gagan Singh (UC Davis Heath, Sacramento CA).
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. All five patients were discharged within 24 hours, reporting no complications and excellent therapeutic outcomes.
Dr. Gagan Singh praised the Protaryx device, emphasizing its superior echogenicity, atraumatic design, and ease of use, describing it as “the next evolution in transseptal puncture.” He further explained,“The device substantially lowers the technical learning curve for targeted transseptal puncture due to its simplistic design, rapid echo visualization of septal contact, and ease of negotiating the septum until the desired target is acquired.”
Dr. James Gammie, Protaryx co-founder and System Chief of Cardiac Surgery at Johns Hopkins Health System, 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.”
The Protaryx Transseptal Puncture Device is the next-generation solution for transseptal puncture, revolutionizing access to the left side of the heart via the fossa ovalis. This innovative device enables zero-exchange procedures, incorporates a proprietary RF guidewire technology compatible with standard electrosurgical generators. Its extendable, highly echogenic atraumatic probe results in superior workflow efficiency. These advanced features provide unparalleled precision, safety, and efficiency, making the system intuitive and accessible for operators of all experience levels.
About Protaryx Medical
Protaryx Medical is a pioneering company dedicated to enhancing access and procedural efficiency in structural heart interventions. The Protaryx Transseptal Puncture Device, delivers groundbreaking advancements in transseptal puncture, simplifying access to the left side of the heart while optimizing workflow. Headquartered in Baltimore, Maryland, Protaryx Medical is committed to driving innovation and improving patient care in structural heart interventions.
For more information, please visit www.Protaryx.com.
