Physeon Positive Clinical Trial Results for its Veinplicity® Device to be Published in The Journal of Vascular Access
SCHAFFHAUSEN, Switzerland, April 01, 2019 (GLOBE NEWSWIRE) -- Physeon GmbH, (“Physeon” or the “Company”), a leading developer of medical technology products for venous access, today announced that the positive results from its second clinical trial with Veinplicity®, have been accepted for publication in the highly respected Journal of Vascular Access.
Lead Investigator for the trial was Rick van Loon, Clinical Epidemiologist and Nurse Anesthetist at Catharina Hospital, Eindhoven, The Netherlands. Van Loon and colleagues had previously developed and published a scoring system called the A-DIVA scale to predict the risk of failed cannulation in pre-operative patients.
According to Van Loon, “Patients at low risk don’t need special intervention, and patients at high risk may need escalation to specialist staff or more invasive procedures, so we wanted to focus on patients in the middle, with medium risk of failed cannulation, to see if we could increase our first attempt success with Veinplicity.”
Results of the trial showed that when using Veinplicity prior to tourniquet in that group of patients, first attempt cannulation success increased from 78% to 92%. Van Loon said, “This means we got a significantly better result when using Veinplicity before applying a tourniquet. Our research tells us that Veinplicity is a really useful tool for patients at medium risk of a failed first attempt.”
Because failed cannulation can result in unnecessary pain for patients and potentially lengthy delays and procedural problems in the pre-op setting, van Loon said, “We believe it’s important to use tools such as the A-DIVA scale to predict difficult venous access and then use available technology such as Veinplicity to prevent it.”
Physeon’s Chief Executive Officer Patrick Kullmann stated, “These results, to be published in The Journal of Vascular Access, show that by reducing first stick failure, Veinplicity is a benefit to both patients and practitioners.”
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 is designed to address 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 which has a physiological effect on veins.
Kullmann went on to say, “This is the second of perhaps multiple clinical papers establishing the efficacy of Veinplicity. The results are impressive and give us confidence that Veinplicity will one day be a standard part of the vascular access toolkit.”
The Veinplicity device is CE Marked and is available in the EU, but it 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.
About The Journal of Vascular Access
The Journal of Vascular Access is a peer-reviewed journal published six times a year, reporting clinical and laboratory studies in the field of vascular access. This includes vascular access for all applications including chemotherapy, haemodialysis, critical care, apheresis, home infusion therapy, and emergency room applications. www.vascular-access.info/
About The A-DIVA scale
“Development of the A-DIVA Scale: A Clinical Predictive Scale to Identify Difficult Intravenous Access in Adult Patients Based on Clinical Observations” by FHJ van Loon et.al. is published in Medicine (Baltimore) 2016
CONTACTPhyseon GmbH Patrick Kullmann+1 763-516-1029 firstname.lastname@example.org