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Mayo Clinic to Conduct US “VIVA” Trial for Veinplicity
SCHAFFHAUSEN, Switzerland, Feb. 04, 2019 (GLOBE NEWSWIRE) -- Physeon GmbH (“Physeon” or the “Company”), a leading developer of medical technology products for venous access, today announced that Mayo Clinic and Gregory Schears, M.D., have been selected as a trial site and principal investigator for Physeon’s “VIVA” (Veinplicity for Improved Venous Access) trial in the United States for its Veinplicity® Device.
“We are very pleased to have Mayo Clinic and Dr. Schears as a trial site and principal investigator for the VIVA trial. This is the most important milestone to date for Veinplicity® as we work towards a US randomized clinical trial,” says Patrick Kullmann, CEO of Physeon GmbH.
The VIVA trial design is similar to a recently conducted EU randomized trial structure. It is randomized using standard tourniquet vs. Veinplicity + tourniquet in 246 patients. The primary end point is first stick success for superiority. Other key end points include number of attempted sticks to successful vein access, total procedure time, subject and clinician satisfaction 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, resulting in needless additional pain for patients and potential damage to veins, leading to increased stress for patients and staff. First attempt failure can also be an administrative and financial burden for both hospitals and outpatient centers.
Veinplicity is intended to address these challenges by significantly increasing vessel 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.
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 Food and Drug Administration. It is not for sale in the US.
Established in 2015 and located in Schaffhausen, Switzerland, Physeon is a boutique medical device company owned by Novintum Medical Technology GmbH. It was created to guide the development and commercialization of new medical innovations. 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