Intelligent Health.tech Issue 23 | Page 6

NEWS

SUCCESSFUL FIRST IN-HUMAN IMPLANTATION OF THE BIVACOR TOTAL ARTIFICIAL HEART BY BAYLOR AND THI DOCTORS

The Texas Heart Institute ( THI ),

BiVACOR , a clinical-stage medical device company , Baylor St . Luke ’ s Medical Center and Baylor College of Medicine have announced the successful first-in-human implantation of the BiVACOR Total Artificial Heart ( TAH ) as part of the US Food and Drug Administration ( FDA ) Early Feasibility Study ( EFS ). BiVACOR ’ s TAH is a titanium-constructed biventricular rotary blood pump with a single moving part that utilises a magnetically levitated rotor that pumps the blood and replaces both ventricles of a failing heart .
The first-in-human clinical study aims to evaluate the safety and performance of the BiVACOR TAH as a bridge-totransplant solution for patients with severe biventricular heart failure or univentricular heart failure in which left ventricular assist device support is not recommended . Following this first implantation completed at Baylor St . Luke ’ s Medical Center by Baylor College of Medicine surgeons , four additional patients are to be enrolled in the study .
“ As for the implantation in the human , it went as expected with no complications . Clinically , the device performed very well ,” said Dr Alexis Shafii , Surgical Director of Heart Transplantation at Baylor St . Luke ’ s Medical Center and Associate
Professor of Surgery – cardiothoracic transplant & circulatory support at Baylor College of Medicine . “ Having this technologically advanced device is offering something special in the field .”
“ The Texas Heart Institute is enthused about the groundbreaking first implantation of BiVACOR ’ s TAH . With heart failure remaining a leading cause of mortality globally , the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant ,” added Dr Joseph Rogers , President and Chief Executive Officer of The Texas Heart Institute and National Principal Investigator on the research .

STRYKER ANNOUNCES LAUNCH OF PANGEA PLATING SYSTEM

Stryker , a global leader in medical technologies , has announced the launch of its Pangea Plating System , which received FDA clearance in late

2023 . Pangea offers a comprehensive and versatile portfolio , providing variable-angle plating for a variety of patient populations .
“ The launch of the Pangea Plating System marks a significant milestone for Stryker , our customers and the patients they serve ,” said Eric Tamweber , Vice President and General Manager of Stryker ’ s Trauma business . “ With the addition of Pangea , Stryker is the go-to partner for everything trauma – nails , plates , external fixation devices and more , backed by our dedicated team and exceptional service .”
The Pangea Plating System is indicated for the internal fixation and stabilisation of bone fractures , osteotomies and arthrodesis in normal and osteopenic bone . Offering an evidence-based design for implant fit , the system was designed to enhance plate fit and screw placement while elevating the plating market through anatomically contoured implants in patient populations with a wide variety of fracture patterns . The intuitive and streamlined instrumentation and implant trays include 20 anatomic plates and 13 utility plates all accessible in one platform .
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