Protaryx Medical, a leader in medical device innovation, is proud to announce the successful completion of its First-in-Human (FIH) study for its groundbreaking transseptal puncture technology. The study, conducted on December 3, 2024, at Sanatorio Italiano de Asunción in Paraguay, involved five patients and was approved by the Research Ethics Committee of the Paraguayan Institute of Social Studies. Dr. Adrian Ebner, Head of the Cardiovascular Department at Sanatorio Italiano Hospital, performed the procedures with guidance from Dr. Gagan Singh, an interventional cardiologist at UC Davis Health in Sacramento, California.
The study successfully met all procedural endpoints, with no adverse events reported. The device’s superior echogenicity enabled rapid and precise transseptal puncture with minimal fluoroscopic exposure. All five patients were discharged within 24 hours, reporting no complications and experiencing excellent therapeutic outcomes.
Dr. Gagan Singh praised the Protaryx device, emphasizing its superior echogenicity, atraumatic design, and ease of use. He described it as “the next evolution in transseptal puncture,” noting that the device significantly lowers the technical learning curve for clinicians. “Its simplistic design, rapid echo visualization of septal contact, and ease of negotiating the septum until the desired target is acquired make it a valuable tool for interventional procedures,” Dr. Singh explained.
Dr. James Gammie, co-founder of Protaryx and System Chief of Cardiac Surgery at Johns Hopkins Health System, also highlighted the device’s advantages, saying, “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, spoke about the broader implications of the milestone, stating, “This achievement marks a pivotal step forward for Protaryx. We are thrilled to move toward our 510(k) submission and bring this innovative device to market, where it has the potential to redefine transseptal procedures.”
The Protaryx Transseptal Puncture Device is a next-generation solution designed to simplify access to the left side of the heart via the fossa ovalis. Its innovative features include zero-exchange procedures and a proprietary RF guidewire technology compatible with standard electrosurgical generators. The device also incorporates an extendable, highly echogenic, atraumatic probe that enhances workflow efficiency. These advanced features offer unmatched precision, safety, and efficiency, making the device intuitive and accessible to operators of all skill levels.
About Protaryx Medical
Protaryx Medical is a pioneering company focused on advancing access and procedural efficiency in structural heart interventions. The company’s flagship device, the Protaryx Transseptal Puncture Device, revolutionizes transseptal puncture by simplifying access to the left side of the heart and optimizing the procedural workflow. Based in Baltimore, Maryland, Protaryx Medical is committed to driving innovation and improving patient care in structural heart procedures.
