FDA clears next-gen device for left-heart access
Protaryx Medical, a Baltimore-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its next-generation Transseptal Puncture Device that provides left-heart access during minimally invasive cardiac interventions.
The newly cleared device was built to support zero-exchange delivery. It includes an atraumatic design that improves efficiency by reducing the necessary number of steps. In addition, it includes an echogenic, extendable positioning probe and a standardized radiofrequency (RF) guidewire compatible with a variety of electrosurgical generators.
The FDA’s decision was based in part of an early first-in-human analysis based on five patients treated with the device. Overall, the Protaryx Transseptal Puncture Device was found to be both safe and effective, leading to no device-related adverse events, short crossing times and a reduction in fluoroscopic exposure.
“This clearance underscores the strength of the technology and its potential to set a new standard for transseptal puncture,” James Gammie, MD, Protaryx Medical co-founder and system chief of cardiac surgery at Johns Hopkins medicine, said in a statement. “By simplifying access to the left atrium, the device can expand procedural adoption while improving safety, precision, and ease-of-use.”
“This achievement reflects the dedication of our team to solving one of the most critical challenges in safe and efficient transseptal access procedures,” added David Mester, Protaryx Medical CEO. “We are now positioned to bring this transformative technology to physicians and patients across the United States.”
The company hopes to continue building momentum by commercializing the device.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.