Published VITAL Study on Bactiguard’s Endotracheal Tube
The study data indicates that by using a Bactiguard endotracheal tube the risk of this complication is significantly reduced”, says Professor Pierre Damas.
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The study data indicates that by using a Bactiguard endotracheal tube the risk of this complication is significantly reduced”, says Professor Pierre Damas.
Dr. K. Saumya, Principal Investigator for the trial, said “This device will be a real life-saver in India. It is small and affordable and will alert people to the need to consult a doctor about their blood pressure before they have symptoms and before it gives rise to awful consequences such as stroke, kidney damage, heart attack or blindness”.
“It is encouraging to see that our Implant System has seen significant results in pre-clinical testing, especially as we prepare for our first clinical trials,” said Seth Bogner, Chairman & CEO of HeartPoint Global.
The results of this study will complement existing international safety and effectiveness data and support a pre-market approval application (PMA) to the U.S. Food and Drug Administration (“FDA”) for approval of the Reducer device in the United States.
The patient, a 32-year-old man with paroxysmal AF and a 60-year-old man with persistent AF underwent successful pulmonary vein and posterior wall isolation using a dedicated PFCA catheter powered by the proprietary Adagio iCLAS™ cryoablation and pulsed-field ablation (PFA) consoles.
The data from the PADN-CFDA pivotal study meet the primary efficacy and safety endpoint.
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