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Physeon Receives Institutional Review Board Approval to Commence US “VIVA” Trial for Veinplicity at Second Site
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, Nov. 06, 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 its second Institutional Review Board (“IRB”) Approval to commence its “VIVA” (Veinplicity for Improved Venous Access) Trial in the United States for the Veinplicity® Device.
The Company’s second site will be a free-standing infusion therapy site in the greater Minneapolis-St. Paul, MN area serving patients requiring IV infusion therapy for a variety of therapies. This standalone clinic will balance the Company’s plans for a hospital-based emergency department site and up to three additional hospital-based sites in the future.
“We are very pleased to have received IRB approval for our second targeted trial site to commence our US based “VIVA” Trial. The Food and Drug Administration has categorized the trial as a Non-Significant Risk (NSR) study, allowing local IRBs to serve as the approval to move ahead with the randomized clinical trial. We look forward to our second site soon commencing the VIVA Trial shortly.” says Patrick Kullmann, CEO of Physeon.
The VIVA Trial design is similar to a successful, previous European Union (EU) randomized trial structure. It is structured as a comparison of standard tourniquet practice versus Veinplicity + tourniquet with 246 total patients for IV Cannulation. A primary end point is first stick IV Cannulation success for superiority. Other key end points include total number of attempted IV sticks to successful vein cannulation, total procedure time, patient and clinician satisfaction, patient pain and anxiety scoring, and change in the vein quality score from baseline to post-stimulation as well as health care economics.
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 and 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 handheld 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