ESM
Current strategies to combat the extraluminal route of infection are focused on Exit Site Management, or ESM.
NexSitetm
A long-term Central Venous Catheter (CVC) to reduce CRBSI by eliminating the exit site as route of infection.
Current strategies to combat the extraluminal route of infection are focused on Exit Site Management, or ESM.
A long-term Central Venous Catheter (CVC) to reduce CRBSI by eliminating the exit site as route of infection.
Marvao Medical Commences Its First Clinical Study
Monday, 11 April, 2011: Marvao Medical, a Galway-based medical device company focused on developing new products that reduce the risk of catheter related infections, commenced its First in Man clinical study of its NexSite vascular access catheter in University Hospital Galway in late March, and enrolled their first patient on April 8, 2011. Catheters equipped with NexSite technology enable the patient’s skin to fully heal into the device at its exit site, a unique advantage over conventional catheters because it prevents pathogens from entering the body though the skin. In addition to its anticipated safety benefits, NexSite catheters should be easier for care givers to maintain and result in significantly reduced healthcare costs.
According to Dr. Gerry O’Sullivan, Consultant Radiologist at UHG and Principal Investigator of the study, “Marvao Medical’s vascular access catheter is an innovative device designed to overcome a critical unmet medical need in patients who required long-term venous access. It should reduce the incidence of catheter related blood stream infection which is a serious and potentially fatal condition. We are proud that a patient from Galway University Hospital has been chosen to be the first in the world to receive this ground-breaking device.”
Chris Davey, CEO of Marvao Medical said, “A key element in Marvao Medical’s strategy has always been to conduct our First in Man studies here in Ireland, and we are delighted to have worked so successfully with the Irish Medicines Board, University Hospital Galway, NSAI, and the HRB Clinical Research Facility Galway to reach this critical milestone. Oncology patients receiving intra-venous chemotherapy are particularly vulnerable to infection, and results from this study will set the stage for additional studies of our novel medical devices in other vulnerable patient populations. The resulting data will provide the basis on which to establish a better standard of care for patients who require long term vascular access”.
Professor Frank Giles, Director of the HRB Clinical Research Facility added, “The HRB CRF at NUI Galway exists to support all aspects of Irish health research. The conduct of First in Man studies is the most demanding and complex clinical aspect of bringing innovative improvements into our local community. We are delighted to be working with Marvao Medical on this important study. The CRF is a resource that benefits our community in many ways, including being a partner to our thriving local medical devices industry.” NUI Galway President Dr James J. Browne welcomed this important development, saying ” this clinical study highlights NUI Galway’s role in translating biomedical research into better clinical outcomes for patients. Our researchers are working with industrial partners and with clinicians to bring new therapies to patients.”
Marvao Medical is based at the Innovation in Business Centre on the Galway Mayo Institute of Technology campus, and is supported by investments from Enterprise Ireland, the Western Development Commission, Enterprise Equity and private investors. Marvao Medical has partnered with Harmac Medical Products (Castlerea, Roscommon) to manufacture NexSite catheter products. More information can be obtained at www.marvaomedical.com.