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Physeon Receives Institutional Review Board Approval to Commence US "VIVA" Trial for Veinplicity
Recent Clinical Study Indicated Device had a Dilatory Effect 38% Greater than other Common Approaches for Veins Targeted for IV Access. Other studies indicate a First IV Stick Success Much Greater Than the Standard of Care.
SCHAFFHAUSEN, Switzerland, Oct. 29, 2018 (GLOBE NEWSWIRE) -- Physeon GmbH ("Physeon" or the "Company"), a leading developer of medical technology products for venous access, today announced that it has received Institutional Review Board ("IRB") Approval to commence its "VIVA" (Veinplicity for Improved Venous Access) Trial in the United States for the Veinplicity® Device.
"We are very pleased to have received IRB approval in our first targeted trial site to commence our US based "VIVA" Trial. As the FDA does not require an IDE for Veinplicity, considering it not a significant risk device, we are permitted to use the IRB approval route with the investigational sites as our approval to move ahead with the randomized clinical trial. Our first site will start the VIVA Trial very soon," says Patrick Kullmann, CEO of Physeon.
Veinplicity is designed to alleviate one of the most common challenges in health care – Difficult Venous Access (DVA). Up to 80% of hospitalized patients need a peripheral IV cannula for the infusion of fluids and medications. Although it's the most common invasive procedure performed in health care, first attempt failure rates can be high, costly, cause needless damage to veins and lead to increased stress for patients and staff. It can also be an administrative and financial burden for the hospital, outpatient centers.
Veinplicity is intended to address these challenges by significantly increasing the size, vessel wall rigidity and stability of targeted peripheral veins, making them easier to find and easier to cannulate for an IV at first attempt. It is the only technology available which has a positive and temporary physiological effect on target veins for the placement of IVs by making the targeted vein temporarily larger, resulting in making it an easier target to hit on a first attempt to cannulate.
Veinplicity consists of a proprietary portable electronic stimulation device which passes a gentle electrical current between proprietary and dedicated electrodes placed on the palm of the hand and the bicep area of the patient.
In one of the Company's initial clinical studies, the dilatory effect of Veinplicity was compared to the dilatory effect of heat pack treatment, which has long been considered the standard of care when veins cannot be palpated. As well as dilating veins 38% more, Veinplicity's effect lasted twice as long as heat treatment, allowing clinicians' crucial extra time to perform this important procedure.
The Veinplicity Device is CE Marked and is available in several countries in the EU. It is not yet approved for use in the US by the FDA.
Established in 2015 and located in Schaffhausen, Switzerland, Physeon is a boutique medical device company created to guide the development and commercialization of new innovations in healthcare. The Company embraces research and science to bring about innovative ideas and medical products that can advance the health and well-being of patients and simplify processes for healthcare professionals. For more information, visit www.physeon.com.
Patrick Kullmann, CEO