Marvao Medical receives a 4th FDA Clearance for their NexSite™ HD Catheter product line
Galway, Ireland, April 22, 2015 – Marvao Medical Devices has announced that they have received FDA 510(k) clearance for their new NexSiteTM HD Split Tip Catheters. This new product range is expected to launch in the US in Q3 2015 and will be available in 24cm, 28cm, 32cm, 36cm, 40cm and 55cm lengths, complimenting the previously cleared NexSiteTM HD Step Tip product range.
“Many physicians prefer to use a split tip catheter, especially in patients who have a history of catheter patency complications. Adding these six Split Tip codes to our NexSiteTM HD product line enables these physicians to utilize NexSiteTM ESMTM technology in this more challenging patient population” stated company co-founder and CEO Chris Davey, “and further signals Marvao’s commitment to providing clinicians with best in class HD catheter products”.
About NexSite ESMTM
Many types of catheters exit the patient’s body through an open wound in the skin, exposing the patient to complications as a result of infection. Effective management of the catheter exit site using antibiotic ointments or antimicrobial dressings has been shown to significantly reduce the risk of potentially deadly catheter related bloodstream infections (CRBSI). To date, logistical and cost barriers have prevented these clinically effective methods from being widely utilized.
Marvao Medical’s NexSiteTM technology is an innovative and natural form of exit site management (ESMTM). It is based on the promotion of tissue ingrowth, and features our patented DISC (Dermal Ingrowth Support Collar) that enables the wound at the catheter exit site to heal. Marvao Medical is working to incorporate NexSite TM technology on a broad range of long term implantable medical devices in an effort to improve patient outcomes and reduce hospital costs.
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 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 (Roscommon, Ireland) to manufacture NexSite catheter products.
More information can be obtained at www.marvaomedical.com.