TheHEALTH January/February 2025 | Page 7

Securing digital health systems
January-February . 2025 | The HEALTH

FOREIGN NEWS 07

New hope for PE

Securing digital health systems

ARGON Medical Devices has taken a pivotal step in addressing pulmonary embolism ( PE ) with the launch of the CLEAN-PE study , a prospective , multicenter clinical trial .

This study aims to assess the safety and effectiveness of the Cleaner™ Pro Thrombectomy System , a novel device designed to remove blood clots in patients diagnosed with pulmonary embolism ( PE ). The trial will involve over 100 participants across multiple healthcare facilities in the United States .
The study ’ s first patient procedure was conducted at Buffalo General Medical Center in New York by Dr David M . Zlotnick , an Interventional Cardiologist .
Dr Aravinda Nanjundappa , another interventional cardiologist at the Cleveland Clinic in Ohio , is leading national oversight .
PE , a life-threatening condition caused by blood clots obstructing lung arteries , affects nearly 900,000 people annually in the United States . If untreated , the mortality rate can reach 30 per cent .
Dr Zlotnick mentioned : “ We are proud to enrol the first patient
DIOSYNVAX , a clinical-stage biotechnology company , has unveiled progress in developing next-generation vaccines for influenza , including a prepandemic Bird Flu vaccine .
This innovative vaccine has shown safety and efficacy in animal models and is now ready for human trials . Using its “ Digital Immune Optimised Synthetic Vaccine ” ( DIOSynVax ) technology , the company leverages artificial intelligence to create robust vaccines targeting emerging viral threats like Bird Flu .
The company ’ s groundbreaking technology was validated during Phase 1 trials of its COVID- 19 vaccine , which demonstrated strong safety and broad immune responses .
Building on these results , DIOSynVax is now focused on influenza vaccines that offer improved safety , fewer doses , and in the CLEAN-PE study utilising the Cleaner™ Pro Thrombectomy system .
Unique treatment options are emerging for the management of this patient population . We are excited to evaluate a new device for patients diagnosed with pulmonary embolism .”
Argon Medical President and CEO George Leondis emphasised the urgency of the initiative , citing a rise in PE-related mortality over the past decade .
He stated : “ Data indicates that pulmonary embolism mortality rates have increased in the last decade .

Next-gen vaccines

adaptability to new viral strains .
With Bird Flu cases rising globally and the first U . S . fatality reported , DIOSynVax aims to provide critical protection against potential outbreaks .
A newly established advisory board , comprising industry and academic experts , will guide the company ’ s clinical and commercial strategies .
“ Our innovative approach holds significant promise both from a public health perspective
“ We aim to help physicians improve patient outcomes by developing new solutions that enable quicker and easier PE interventions .”
The Cleaner™ Pro Thrombectomy System , marketed as the CLEANER Vac™ , is designed for aspiration thrombectomy in peripheral venous vasculature . While the device is not yet FDAapproved for pulmonary use , it represents a promising development in PE treatment .
With a global presence and renowned product lines , the company remains committed to improving patient care worldwide .
and a commercial standpoint , and we are committed to accelerating its development as a vital countermeasure against future pandemics .
“ Notably , our Bird-flu vaccine has several advantages to others and should be utilised to de-risk the current pandemic threat ,” said DIOSynVax Chief Executive Officer Dr Ronald Moss , emphasising the Bird Flu vaccine ’ s potential to mitigate current threats .
THE European Commission has unveiled a strategic EU Action Plan aimed at enhancing cybersecurity in hospitals and healthcare institutions .
As one of the Commission ’ s top priorities , the plan seeks to safeguard patient data and ensure the resilience of medical systems in the face of rising cyber threats .
In 2023 , healthcare reported more cybersecurity incidents than any other sector , with 309 significant breaches across EU countries . The increasing reliance on digital health tools , such as electronic medical records and connected devices , has heightened vulnerabilities . These threats pose risks not only to patient confidentiality but also to critical healthcare operations , potentially endangering lives .
The Action Plan focuses on bolstering the healthcare sector ’ s defences against these risks . Building on existing EU cybersecurity regulations , it extends protection to general medical practices while addressing the prevention , detection , and mitigation of cyberattacks .
A key component is the creation of a pan-European Cybersecurity Support Centre to offer targeted assistance to healthcare providers . The initiative will be refined collaboratively by year-end , with implementation planned over the next two years .
Digital transformation in healthcare has brought about numerous benefits , including improved patient care and innovative medical solutions . However , it also presents challenges in ensuring data and system security .
With this Action Plan , the EU aims to balance innovation with robust safeguards , creating a safer and more reliable environment for patients and healthcare professionals alike .