AuriGen Medical, a medical device company specializing in left atrial appendage occlusion (LAAO) technology, today announced the successful treatment of their first patient in its first-in-human clinical study. The procedure, performed by Dr Matt O’Connor, Cardiologist and Electrophysiologist at Auckland City Hospital New Zealand, marks a significant milestone in the clinical validation of AuriGen’s novel “Zenith” LAAO device.
Atrial fibrillation (“AF”) affects over 60 million people worldwide and significantly increases stroke risk, with over 90% of stroke-causing clots originating in the left atrial appendage (“LAA”). This makes LAA closure vital for patients who cannot tolerate long-term anticoagulation therapy. The Zenith device simplifies LAA closure, crucial for reducing stroke risk in AF patients.
Zenith is implanted through a quick, minimally invasive procedure via a small groin incision. The delivery system guides the implant to the heart sealing the LAA and offers fully controllable deployment which adapts to each patient’s unique anatomy for a precise fit. Zenith is designed for non-traumatic repositioning, allowing physicians to perform leak-checks and real-time adjustments. Zenith’s unique self-closing covering encourages heart tissue-growth, designed to support healing and long-term LAA closure.
“I am very encouraged by how the Zenith device performed in this important first case. The patient recovered exceptionally well and has been discharged home” said Dr Matt O’Connor. “From a physician’s perspective, Zenith’s independent anchors provide a distinct advantage by allowing easy repositioning and placement optimization of the implant without risking injury to the heart. This in combination with the intra-procedural leak analysis, represents a significant advance in the left atrial appendage occlusion technology available to our AF patients who are at significant stroke risk.”
“This first-in-human procedure of the Zenith device is a huge milestone for AuriGen Medical,” said the company’s Chairman Pierre Chauvineau. “It marks a critical step forward in LAAO technology. As we advance our clinical trials, we are committed to improving outcomes for our LAAO patients and exploring new Zenith applications that can benefit a wider range of cardiac patients.”
