Marvao Medical Receives second FDA Clearance for its NexSite™ HD Catheter product line

February 10th, 2014 – Marvao Medical Devices has announced that it has received FDA 510(k) clearance for three additional lengths of its NexSite™ HD Catheter product line. These new lengths (32cm, 36cm and 40cm) complement the two previously cleared lengths (24cm and 28cm) and complete the core offering of the company’s first NexSite™ Hemodialysis Catheter product line.

“Adding these lengths enables us to accelerate clinical evaluation of NexSite™ HD Catheters’ ability to improve patient outcomes and reduce healthcare costs” stated company CEO Chris Davey, “and it signals our commitment to commercialization of a full range of NexSite™ dialysis catheters in 2014”.

About NexSite ESM – Many types of catheters exit the patient’s body through an open wound in the skin.  Effective management of the catheter exit site using antibiotic ointments or antimicrobial dressings has been shown to reduce the risk of catheter related bloodstream infection (CRBSI) associated with these catheters.  Marvao Medical’s innovative NexSite™ ESM™ technology is a novel technology for the management of the catheter exit site. It is based on tissue ingrowth and features our patented DISC™ (Dermal Ingrowth Support Collar) that enables the wound in the skin at the catheter exit site to heal. Marvao Medical is working to incorporate NexSite™ ESM™ technology on a broad range of long term implantable medical devices.
About Marvao Medical – Marvao Medical specializes in the development, manufacturing and marketing of innovative medical devices to address unmet clinical needs and deliver high quality of care to the patient population. Based at the Innovation in Business Centre on the Galway Mayo Institute of Technology campus, Marvao Medical Devices is supported by investments from Enterprise Ireland, the Western Development Commission, Enterprise Equity and private investors. Marvao Medical Devices has partnered with Harmac Medical Products (Castlerea, Roscommon) to manufacture NexSite™ catheter products.