Physeon Selects RCRI for Pivotal Study of Veinplicity Device
Recent Clinical Trial Indicated Device had a Dilatory Effect 38% Greater than Standard of Care
Physeon GmbH, a leading developer of medical technology products for venous access, today announced that it has selected The Regulatory and Clinical Research Institute, Inc., (“RCRI”) as its Clinical Research Organization (CRO) and regulatory consultant for its prospective, randomized, pivotal clinical study of the Veinplicity® device.
This Many healthcare professionals consider heat treatment, usually a heat pack applied to the forearm, one of the most effective ways of dilating vessels to aid intravenous cannulation. This study performed by Andrew Barton, Advanced Nurse Practitioner Vascular Access at Frimley Park Hospital in the United Kingdom, compared the dilatory effect of Veinplicity with this age-old standard. Using ultrasound to measure the mean maximum vein diameter increase, Barton found that Veinplicity dilated veins by 50% on average while heat pack dilated veins by 36%. Additionally, Veinplicity’s dilatory effect was more than two times longer than it was with heat pack.
“We’re excited to partner with RCRI for this important clinical trial. Selecting a high quality CRO is a critical step in the development process and we see RCRI as the partner best capable of helping us integrate all of our strategies in gaining regulatory approval in the US by delivering high quality clinical data.” Says Patrick Kullmann, CEO of Physeon.
Kullmann went on to state, “Physeon will collaborate with RCRI for its multi-center, pivotal US trial, supporting our regulatory, clinical and health care economics strategies and interactions. Study kick off meetings will start in April with patient enrollment expected to start shortly thereafter.”
Veinplicity is designed to alleviate one of the most common challenges in healthcare – difficult venous access. Up to 80% of hospitalized patients need a peripheral IV cannula for the infusion of fluids and medication. Although it’s the most common invasive procedure performed in hospitals, first attempt failure rates are high, and lead to increased stress for patients and staff as well as added administrative and financial burden for the hospital.
Veinplicity addresses these challenges by significantly increasing the size, rigidity and stability of forearm veins, making them easier to find and easier to cannulate first time. Veinplicity consists of a portable electronic stimulation device which passes a gentle current between electrodes placed on the palm and the bicep. It is the only technology available which has a physiological effect on veins.
In the Company’s initial clinical trial the dilatory effect of Veinplicity was compared to the dilatory effect of heat treatment, which has long been considered the standard of care. 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 the EU, but is not FDA approved and is not for sale in the US.
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
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