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Liquet™ Medical Receives Second FDA 510(k) Clearance for Versus™ Catheter

Liquet Medical Inc., a pioneering medical device company committed to advancing patient care through innovative technologies, today announced it has received a second 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new configuration of the Versus™ Catheter. The latest clearance expands the company’s proprietary platform and opens access to a broader segment of interventional physicians. The Versus Catheter provides real-time pulmonary artery (PA) pressure measurements to empower clinicians to optimize treatment based on each individual patient’s response. This novel technology grows the new treatment category of Hemodynamics-Led Thrombolysis (HLT),” a physiology-guided approach.

As blood clot procedures evolve towards more rapid treatment strategies, the Versus™ Catheter is uniquely positioned to fit perfectly within this new paradigm.

“Current catheter-directed lytic therapy is like driving at night without headlights – you’re making important decisions without full visibility,” said Dr. Patrick Kelly, vascular surgeon and inventor. “Incorporating real-time PA pressure data provides objective physiologic feedback which can help physicians better understand patient response and has the potential to optimize therapy decisions.”

Key Features and Benefits of the Versus™ Catheter:

  • Integrated Real-Time Pulmonary Artery Pressure Monitoring: Provides physicians live data to assess patient hemodynamics before and during therapy to optimize treatment decisions.

  • Dual-Tip Telescoping Design: Enables simultaneous treatment of both lungs with a single device, offering access site alternatives to the physician, and improving healthcare efficiency.

  • New Configuration for Interventional Radiology: Enhanced torque control and compatibility with thicker guidewires to meet IR workflow preferences and expand adoption across specialties.

John Schindler, CEO of Liquet Medical, added “Pulmonary embolism therapy is evolving rapidly, but most systems still treat the clot without directly measuring physiologic response. Our platform enables physicians to see, in real time, how the patient is responding – and act accordingly. This second clearance allows us to serve both interventional cardiology and interventional radiology with purpose-built systems.”

This second FDA clearance strengthens Liquet’s future commercial offerings as it advances early clinical experiences and expands market access across interventional specialties. The company has plans to conduct a US IDE trial for the treatment of pulmonary embolism.

Read more here.

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