I-VASC
I-VASC announces the first clinical use of VELEX™, the Empty Vein Ablation (EVA) technology device to treat Chronic Venous Insufficiency (CVI).
I-VASC, the Italy based start-up company which has developed and CE Marked its innovative percutaneous VELEX™ system to treat CVI, a condition that includes varicose veins disease, announces today that VELEX™ has entered clinical use, with the first two cases performed last week in Milan at the Policlinico San Donato center, the renowned institution of medical science.
These first two cases represent the start of the V.A.S.C. post-market clinical trial, that will be executed in a group of qualified centers, coordinated by Policlinico San Donato, that notably includes the San Raffaele Hospital in Milan and other international sites.
VELEX™ is an innovative minimally invasive catheter system which performs an advanced form of sclerotherapy (chemical ablation) based on the Empty Vein Ablation concept, invented and developed by Mario Salerno (MD), who is also the founder of I-VASC and the chairman of the board.
The EVA technology allows a fully controlled application of the sclerosant drug in the segment of vein to be treated. Before injection of the drug this segment is emptied from blood and isolated from the rest of the venous system, a solution conceived to increase both efficacy and safety of sclerotherapy through performing a simple and quick procedure.
“We are proud of having started the clinical use of VELEX™ as per our product roll-out plans” stated Daniele Zanotti, I-VASC's CEO, “and having done that at such a qualified center as San Donato, with an investigator of the experience Paolo Righini (MD) and the impressive team of Prof. Giovanni Nano. This for us, is only the first step of a market introduction path that will lead VELEX™ to be progressively introduced in the European market first, as it is already CE Marked, as well as the US market by pursuing the FDA approval too”.
Paolo Righini (MD), principal investigator of the V.A.S.C. trial, has stated “We have been following the development of this technology for a while and we were very interested in verifying its clinical performance. VELEX™ is based on a simple and elegant concept that has the potential to make endovascular chemical ablation more effective from every point of view, especially for patients with larger vessels such as the large saphenous veins treated today in this study. These veins would be the most challenging for current sclerotherapy. They would perhaps be alternatively treated with thermal/mechanical ablation, that however, require the use of anaesthesiologic drugs because of considerable intra-procedural discomfort. While only follow-up on all the approximate 30 patients to be enrolled in the study will provide sufficient data for an adequate evaluation, the procedural success and the short-term evidence give us hope for the best”.
“I am thrilled that the EVA technology has been eventually become available to CVI patients” said Mario Salerno (MD), inventor of the technology, founder of I-VASC and a vascular surgeon himself. “I have devised this concept after many years of experience with various techniques, especially sclerotherapy, that systematically fall short not only in efficacy, especially for the larger vessels to treat, but sometimes also their safety, difficulty to be used, patients’ compliance, and lastly not to mention the costs for the most recent ones. With the EVA concept I intended to strike a new level of performances that could overcome all these compromises and establish a novel therapeutic paradigm. Only the clinical use will tell us whether we have succeeded, but after the first two cases our expectation has definitely risen”.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220614005546/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
FEELM1.7.2022 10:09:09 CEST | Press release
SMOORE Becomes One of the Shortlisted Enterprises in Shenzhen Municipal Industrial Design Development Support Program
DEXLEVO1.7.2022 09:23:13 CEST | Press release
DEXLEVO Strengthens Global Reputation of GOURI at IMCAS, the World’s Largest Beauty Anti-Aging Society
MA-TAKEDA-PHARMACEUTICAL1.7.2022 00:03:13 CEST | Press release
Takeda’s TAKHZYRO® (lanadelumab) Demonstrated Positive Results in the Prevention of HAE Attacks in First and Only Open-Label Phase 3 Trial in Children Ages 2 to <12 Years
CA-NEXON-AMERICA30.6.2022 22:22:06 CEST | Press release
Venerable MMORPG Mabinogi Enters The Great Era Of Commerce With The First Of Two Summer Game Updates
VA-VERISIGN30.6.2022 22:08:04 CEST | Press release
Verisign Reports Internet Has 350.5 Million Domain Name Registrations at the End of the First Quarter of 2022
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom